Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
276
Countries
1
Sites
11
Oncology - Breast cancer
Evaluate the zAvatar-test as a predictive model of treatment efficacy to aid therapeutical decisions, in patients with relapsed ovarian cancer and in patients with metastatic breast cancer with malignant pleural effusion and/or ascites. To achieve this, we will compare: a) Progression Free Survival (PFS) of patients wi…
Key facts
- Sponsor
- Rita Fior, Champalimaud Clinical Centre, Rita Fior
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 May 2025 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Liga Portuguesa Contra o Cancro · Champalimaud Foundation
External identifiers
- EU CT number
- 2023-509598-22-01
- WHO UTN
- U1111-1308-0481
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Evaluate the zAvatar-test as a predictive model of treatment efficacy to aid therapeutical decisions, in patients with relapsed ovarian cancer and in patients with metastatic breast cancer with malignant pleural effusion and/or ascites.
To achieve this, we will compare:
a) Progression Free Survival (PFS) of patients with relapsed ovarian cancer treated according to zAvatar-test-based therapeutic decision versus those treated according to clinical-choice (standard of care);
b) Compare PFS of metastatic breast cancer patients treated according to zAvatar-test-based therapeutic decision versus those treated according to clinical-choice (standard of care).
Secondary objectives 6
- Compare the OS of patients with relapsed ovarian cancer treated according to zAvatartest- based therapeutic decision and those treated according to clinical-choice (standard of care);
- Compare the OS of patients with metastatic breast cancer treated according to zAvatar-test-based therapeutic decision and those treated according to clinical-choice (standard of care)
- Confirm the predictive value of the zAvatar-test by comparing the patient clinical response with the response in its matching zAvatar-test, determining specificity, sensitivity, positive and negative predictive values.
- Compare Health Care Sources (HCS) utilization, namely emergency room visits and hospitalizations, of relapsed ovarian cancer patients treated according to zAvatar-testbased therapeutic decision and those treated according to clinical-choice (standard of care).
- Compare HCS utilization, namely emergency room visits and hospitalizations, of metastatic breast cancer patients treated according to zAvatar-test-based therapeutic decision and those treated according to clinical-choice (standard of care).
- Study clonal and tumor microenvironment (TME) diversity as well as signaling pathways in multi-resistant/multi-sensitive tumors and in responders/non-responders tumors, at the transcriptomic (single-cell) level (scRNAseq). Identification of these signatures may lead to new biomarkers and also discover new mechanisms of resistance and possible new therapeutical targets.
Conditions and MedDRA coding
Oncology - Breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 21.1 | PT | 10066697 | Ovarian cancer recurrent | 100000004864 |
| 27.0 | PT | 10055113 | Breast cancer metastatic | 100000004864 |
| 21.1 | PT | 10057654 | Breast cancer female | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509598-22-00 | zAvatar test-guided therapeutic decision vs standard of care, in relapsed ovarian cancer and in metastatic breast cancer - A multicentric randomized clinical study with intervention | Rita Fior |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- Ovarian cancer - Women aged ≥18 years, who are able to understand the study procedures and to provide a signed written Informed Consent Form (ICF) prior to study inclusion.
- Breast cancer - ECOG performance status 0-2 (to enable treatment).
- Breast cancer - Second line or following lines of treatment are accepted, however the patient should be included prior to starting a new line of treatment and should have at least 2 treatment options of therapy to be tested, according to guidelines.
- Breast cancer - Patients with adequate bone marrow and coagulation function, adequate liver, renal and cardiac functions to allow treatment.
- Breast cancer - Measurable disease (at least one measurable lesion per RECIST 1.1 criteria or PERCIST 1.1 criteria).
- Ovarian cancer - Inoperable high grade serous carcinoma (HGSC) or high grade endometrioid relapsed ovarian cancer, with high-volume of ascites or MPE, which warrants drainage: a. with platinum-sensitive disease: defined as disease progression ≥ 6 months following the last administered dose of platinum-based therapy. OR b. with platinum-resistant disease: defined as disease progression < 6 months following the last administered dose of platinum-based therapy. iii. ECOG performance status 0-2 (to enable treatment)
- Ovarian cancer - Patients for whom there is a decision for therapy treatment.
- Ovarian cancer - First line or following lines of treatment upon relapse are accepted, however the patient should be included prior to starting a new line of treatment and should have at least 2 treatment options to be tested, according to guidelines.
- Ovarian cancer - Patients with adequate bone marrow and coagulation function, adequate liver, renal and cardiac functions to allow treatment.
- Ovarian cancer - Measurable disease (at least one measurable lesion per RECIST 1.1 criteria or PERCIST 1.1 criteria)
- Ovarian cancer - ECOG performance status 0-2 (to enable treatment)
- Breast cancer - Women aged ≥18 years, who are able to understand the study procedures and to provide a signed written ICF prior to study inclusion.
- Breast cancer - Confirmed stage IV breast cancer (AJCC 8th edition classification), with high-volume of ascites or MPE which warrants drainage. All tumors should be HER2-negative metastatic breast cancer, independently of Estrogen Receptor (ER) status.
- Breast cancer - Patients for whom there is a decision for therapy treatment.
Exclusion criteria 4
- Exclusion criteria for Ovarian & Breast Cancer - Patients with clinical conditions that, in the physician co-investigator opinion, could compromise the participation in the study and compliance with study procedures.
- Exclusion criteria for Ovarian & Breast Cancer - Patients pregnant or breastfeeding.
- Exclusion criteria for Ovarian & Breast Cancer - Patients currently enrolled in other clinical trials, under active treatment.
- Exclusion criteria for Ovarian & Breast Cancer - Patients that need urgent treatment (visceral crisis).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- PFS of patients with relapsed ovarian cancer treated according to zAvatar-test-based therapeutic decision and those treated according to clinical-choice (standard of care).
- PFS of metastatic breast cancer patients treated according to zAvatar-test-based therapeutic decision and those treated according to clinical-choice (standard of care).
Secondary endpoints 4
- Response rate (RR) and overall survival (OS) of relapsed ovarian cancer patients treated according to zAvatar-based therapeutic decision and those treated according to clinical-choice (standard of care).
- RR and OS of metastatic breast cancer patients treated according to zAvatar-based therapeutic decision and those treated according to clinical-choice (standard of care).
- Describe HCS utilization between both treatment arms for both disease – relapsed ovarian cancer and metastatic breast cancer.
- Sequence selected multi-resistant/multi-sensitive responders/non-responders tumors, at the transcriptomic (single-cell) level (scRNAseq)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 62
SUB191213 · Substance
- Active substance
- Sacituzumab Govitecan
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg/Kg milligram(s)/kilogram
- Max total dose
- 10 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00069MIG · Substance
- Active substance
- Vinorelbine
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 80 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00069MIG · Substance
- Active substance
- Vinorelbine
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 80 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00069MIG · Substance
- Active substance
- Vinorelbine
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 30 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 120 mg/m2 milligram(s)/sq. meter
- Max total dose
- 120 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13933MIG · Substance
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13933MIG · Substance
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01915MIG · Substance
- Active substance
- Epirubicin Hydrochloride
- Pharmaceutical form
- INTRAVESICAL SOLUTION/SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 120 mg/m2 milligram(s)/sq. meter
- Max total dose
- 120 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01915MIG · Substance
- Active substance
- Epirubicin Hydrochloride
- Pharmaceutical form
- INTRAVESICAL SOLUTION/SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 120 mg/m2 milligram(s)/sq. meter
- Max total dose
- 120 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01915MIG · Substance
- Active substance
- Epirubicin Hydrochloride
- Pharmaceutical form
- INTRAVESICAL SOLUTION/SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 120 mg/m2 milligram(s)/sq. meter
- Max total dose
- 120 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01915MIG · Substance
- Active substance
- Epirubicin Hydrochloride
- Pharmaceutical form
- INTRAVESICAL SOLUTION/SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 120 mg/m2 milligram(s)/sq. meter
- Max total dose
- 120 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180707 · Substance
- Active substance
- Alpelisib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180707 · Substance
- Active substance
- Alpelisib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180707 · Substance
- Active substance
- Alpelisib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180394 · Substance
- Active substance
- Talazoparib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180394 · Substance
- Active substance
- Talazoparib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180394 · Substance
- Active substance
- Talazoparib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 175 mg/m2 milligram(s)/sq. meter
- Max total dose
- 175 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- POWDER FOR SUSPENSION FOR SOLUTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 260 mg/m2 milligram(s)/sq. meter
- Max total dose
- 260 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11191MIG · Substance
- Active substance
- Topotecan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1.5 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1.5 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11191MIG · Substance
- Active substance
- Topotecan
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 2.3 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2.3 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11191MIG · Substance
- Active substance
- Topotecan
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1.5 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1.5 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11191MIG · Substance
- Active substance
- Topotecan
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 2.3 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2.3 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 600 mg/m2 milligram(s)/sq. meter
- Max total dose
- 600 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 600 mg/m2 milligram(s)/sq. meter
- Max total dose
- 600 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Doxorubicin Hydrochloride, Liposomal
SUB126795 · Substance
- Active substance
- Doxorubicin Hydrochloride, Liposomal
- Pharmaceutical form
- CONCENTRATE FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16402MIG · Substance
- Active substance
- Bevacizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 15 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB181124 · Substance
- Active substance
- Mirvetuximab Soravtansine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02065MIG · Substance
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02065MIG · Substance
- Active substance
- Everolimus
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02065MIG · Substance
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02065MIG · Substance
- Active substance
- Everolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07492MIG · Substance
- Active substance
- Exemestane
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB188357 · Substance
- Active substance
- Trastuzumab Deruxtecan
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 5.4 mg/kg milligram(s)/kilogram
- Max total dose
- 5.4 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB31126 · Substance
- Active substance
- Eribulin Mesylate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1.23 mg/kg milligram(s)/kilogram
- Max total dose
- 1.23 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02324MIG · Substance
- Active substance
- Gemcitabine Hydrochloride
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB180246 · Substance
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32234 · Substance
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32234 · Substance
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB178312 · Substance
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1680 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB178312 · Substance
- Active substance
- Atezolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1680 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB177204 · Substance
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rita Fior
- Sponsor organisation
- Rita Fior
- Address
- Avenida Brasilia
- City
- Lisbon
- Postcode
- 1400-038
- Country
- Portugal
Scientific contact point
- Organisation
- Rita Fior
- Contact name
- Rita Fior
Public contact point
- Organisation
- Rita Fior
- Contact name
- Rita Fior
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Evidenze Portugal Unipessoal Lda. ORG-100042799
|
Alges, Portugal | On site monitoring, Code 5 |
Champalimaud Clinical Centre
- Sponsor organisation
- Champalimaud Clinical Centre
- Address
- Avenida Brasilia S/n
- City
- Lisbon
- Postcode
- 1400-038
- Country
- Portugal
Scientific contact point
- Organisation
- Rita Fior
- Contact name
- Rita Fior
Public contact point
- Organisation
- Rita Fior
- Contact name
- Rita Fior
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Evidenze Portugal Unipessoal Lda. ORG-100042799
|
Alges, Portugal | On site monitoring, Code 5 |
Rita Fior
- Sponsor organisation
- Rita Fior
- Address
- Avenida Brasilia
- City
- Lisbon
- Postcode
- 1400-038
- Country
- Portugal
Scientific contact point
- Organisation
- Rita Fior
- Contact name
- Rita Fior
Public contact point
- Organisation
- Rita Fior
- Contact name
- Rita Fior
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Evidenze Portugal Unipessoal Lda. ORG-100042799
|
Alges, Portugal | On site monitoring, Code 10, Code 11, Code 12, Code 5, Data management, E-data capture, Code 8 |
Sponsor responsibilities
- Article 77 compliance
- Rita Fior
- Contact point sponsor
- Rita Fior
- Article 77 implementation
- Rita Fior
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ongoing, recruiting | 276 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Medical oncology - Ovarian, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Medical oncology - Ovarian, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Santa Maria E.P.E.
Medical oncology - Breast, Avenida Professor Egas Moniz, 1649-035, Lisbon
Champalimaud Clinical Centre
Breast, Avenida Brasilia S/n, 1400-038, Lisbon
Champalimaud Clinical Centre
Gynecology, Avenida Brasilia S/n, 1400-038, Lisbon
Unidade Local De Saude Lisboa Ocidental E.P.E.
Medical oncology, Estrada Forte Do Alto Duque, 1449-005, Lisbon
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Medical oncology - Ovarian, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Medical oncology - Breast, Rua Professor Lima Basto, 1099-023, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Medical oncology - Breast, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Medical oncology - Breast, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Medical oncology - Ovarian, Rua Professor Lima Basto, 1099-023, Lisbon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Portugal | 2025-05-13 | 2025-05-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 78 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_List of Possible Medications_tc | 2.0 |
| Protocol (for publication) | D1_Protocol 2023-509598-22_public | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main EN | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main PT | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Atezolizumab Tecentriq_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bevacizumab Alymsys_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bevacizumab Avastin_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bevacizumab MVASI_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bevacizumab Oyavas_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bevacizumab VEGZELMA_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bevacizumab Zirabev_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabina Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabina Normon 150mg_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabina Normon 500mg_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatina Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatina Hikma_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatina Kabi_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ciclofosfamida Endoxan pill_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ciclofosfamida Endoxan powder_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Docetaxel Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Docetaxel Aurovitas_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Docetaxel Hikma_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Docetaxel Seacross_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorrubicina Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorrubicina Actavis_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorrubicina Caelyx pegylated liposomal_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorrubicina medac_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorrubicina Myocet liposomal_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorrubicina ZOLSKETIL pegylated liposomal_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Etoposido Sandoz_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fulvestrant Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fulvestrant Ambiful_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fulvestrant Faslodex_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fulvestrant Hikma_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fulvestrant Mylan_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fulvestrant Teva_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabina Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabina Aurovitas_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabina Gemcit_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabina Hikma_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabina Kabi_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gemcitabina Venus Pharma_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mirvetuximab soravtansine_Elahere_AbbVie_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Olaparib Lynparza_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel Abraxane_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel Aurovitas_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel Kabi_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel Pazenir_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Palbociclib IBRANCE_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ribociclib Kisqali_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Sacituzumab govitecan Trodelvy_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Topotecano Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Topotecano Hikma_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Topotecano HYCAMTIN_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vinorelbina Navirel_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vinorrelbina Accord_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vinorrelbina Aurovitas_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vinorrelbina Generis_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vinorrelbina medac_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC vinorrelbina NAVELBINE_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Abemaciclib_Verzenios_Eli Lilly Nederland_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Alpelisib_Piqray_Novartis_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Epirubicin_10mg_Hikma_public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Eribulin_Baxter_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Eribulin_Halaven_Eisai_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Everolimus_Afinitor_Novartis_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Everolimus_Mylan_Mylan_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Everolimus_TAD_TAD_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Everolimus_Teva_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Exemestan_Pfizer_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Exemestan_PLS Pharma_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab_Merck _public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Talazoparib_Talzenna_Pfizer_public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Trastuzumab-deruxtecan_Daiichi Sankyo_public | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2023-509598-22 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PT 2023-509598-22 | 3.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-24 | Portugal | Acceptable 2024-10-15
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-03 | Portugal | Acceptable 2025-05-20
|
2025-05-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-05 | Portugal | Acceptable 2025-06-20
|
2025-06-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-03 | Portugal | Acceptable | 2025-10-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-16 | Portugal | Acceptable | 2026-02-06 |