Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
373
Countries
7
Sites
49
Localized ER+ breast cancer
The primary objective of this trial is to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with pathologic stage IIIII ER+/HER2- early breast cancer.
Key facts
- Sponsor
- European Organisation For Research And Treatment Of Cancer
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Jun 2019 → ongoing
- Decision date (initial)
- 2024-02-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Pfizer Belgium
External identifiers
- EU CT number
- 2023-505223-31-00
- EudraCT number
- 2018-002553-30
- ClinicalTrials.gov
- NCT03609047
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
The primary objective of this trial is to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with pathologic stage IIIII ER+/HER2- early breast cancer.
Secondary objectives 7
- To evaluate the efficacy with respect to different time-to-event endpoints (distant recurrence-free interval (DRFI), breast cancer specific survival (BCSS), OS) at 3 years in both arms
- To evaluate toxicity in both arms
- To evaluate the treatment discontinuation and dose reduction rates in both arms
- To assess the reasons for treatment discontinuation
- To evaluate completion of oral therapy in the experimental arm
- To assess the evolution of Health-Related Quality of Life (HRQoL) in both arms
- To assess the evolution, prognostic and predictive effects of geriatric assessment in both arms
Conditions and MedDRA coding
Localized ER+ breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10006291 | Breast neoplasms malignant and unspecified (incl nipple) | 10029104 |
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 23.0 | LLT | 10070577 | Oestrogen receptor positive breast cancer | 10029104 |
| 20.0 | HLT | 10006290 | Breast and nipple neoplasms malignant | 10029104 |
| 23.0 | LLT | 10070575 | Estrogen receptor positive breast cancer | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 16
- Women or men with pathologic stage II or stage III, early invasive breast cancer according to the UICC 8th edition for TNM classification
- Patient must have undergone breast +/- axillary surgery with curative intent for the current malignancy ≤12 weeks before randomization. The final primary tumor surgical specimen must have R0 margins free from tumor.
- Patients must have sufficient resolution of any surgical side effects from the last surgery per physician assessment, with no active wound healing complications at the time of randomization.
- Incentive to undergo adjuvant radiation therapy when indicated per local institutional guidelines. Note: For patients in the palbociclib arm, radiation therapy when indicated has to start ≤13 weeks after last surgery. The endocrine therapy can be initiated during or after the radiation therapy but not later than 4 weeks after the last radiotherapy. Palbociclib has to start ≤4 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy and palbociclib have to be initiated ≤13 weeks after last surgery. Note: For patients in the chemotherapy arm, chemotherapy has to be the first adjuvant treatment and has to start ≤ 13 weeks after the last surgery. When radiation therapy is indicated, this treatment has to start ≤9 weeks after the last chemotherapy administration. Adjuvant endocrine therapy can be initiated during or after the radiation therapy but not later than 4 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy has to be initiated ≤6 weeks after last chemotherapy administration.
- Adequate baseline organ function, evidenced by the following laboratory results within 3 weeks of randomization: - Hemoglobin ≥ 9 g/dL - Absolute neutrophil count (ANC) ≥ 1500/mm3 - Platelet count ≥ 100,000/mm3 - Total bilirubin ≤ 1.5 upper limit of normal (ULN), or total bilirubin ≤ 3.0 ×ULN in patients with documented Gilbert's Syndrome. - Glomerular Filtration Rate (GFR) ≥ 30 ml/min according to MDRD formula or CKD-EPI formula or Cockcroft and Gault formula - SGOT (AST), SGPT (ALT) and alkaline phosphatase ≤ 2.5 × ULN
- For men participating in the trial: • As fertility may be affected permanently with protocol treatment, we advise offering to patient sperm preservation prior to treatment. • With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive** method that together result in a failure rate of <1% per year during the treatment period and for 6 months after the last dose of chemotherapies or 3 months and half (14 weeks) after the last dose of palbociclib. Men must refrain from donating sperm during the same period. • With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of chemotherapies or 3 months and half (14 weeks) after last dose of palbociclib to avoid exposing the embryo. ** For female partner, a highly effective method of birth control includes: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence
- Signed, written informed consent.
- Histologically confirmed ER+ (at least 10 % of cells staining positive for ER), HER-2 negative, early invasive breast cancer based on results of local pathology. Testing may be performed on diagnostic core biopsy or resection specimen.
- In patients with multicentric, multifocal and/or bilateral breast cancer, all histopathologically examined invasive tumors must meet pathologic criteria regarding ER and HER2-status described above.
- Adjuvant chemotherapy indicated and feasible according to treating physician and patient, based on standard clinicopathological parameters (tumor size, lymph node involvement, general health status, proliferation marker, patient wish) and gene expression profile if available.
- Adjuvant chemotherapy with both anthracycline and taxanes (in combination or in sequence) considered not indicated or not feasible according to treating physician.
- Age ≥70 years
- WHO Performance status 0-2
- Completed G8 geriatric assessment within 3 weeks of randomization
- Participation in translational research is mandatory and therefore patient must consent for it. Patient should allow sequential sampling of blood during the course of the trial
- Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.
Exclusion criteria 14
- Evidence of macroscopic distant metastases, investigated according to local institutional guidelines
- History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including known HIV, active hepatitis B and/or hepatitis C infection), symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or uncontrolled diabetes. Note: For patients for whom doxorubicin or epirubicin is planned, an adequate baseline cardiac function (left ventricular ejection fraction ≥ 50%) should have been proven no more than 1 year before treatment start.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Other malignancy within the last 5 years except: adequately treated non-metastatic non-melanoma skin cancer, or successfully treated in situ carcionoma for example curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast.
- Previous history of invasive breast cancer
- Systemic anticancer therapy prior to the breast cancer surgery
- Prior therapy with any CDK4/6 inhibitor
- Concurrent investigational agent within 28 days of randomization or five elimination half-lives, whichever is longer
- Concomitant anticancer treatment with the exception of bone antiresorptive agents or LHRH agonists in male patients treated with an aromatase-inhibitor
- History of allergic reactions attributed to compounds of chemical or biological composition similar to palbociclib or to chemotherapy components
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- Medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization
- Patients who received treatment with live vaccines within 30 days prior the first dose of study medication.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint in this study is the 3-year distant recurrence-free interval rate in the experimental arm.
Secondary endpoints 8
- Distant recurrence-free interval at 3 years in the control arm.
- Breast cancer specific survival at 3 years in both arms.
- Overall survival at 3 years in both arms.
- Adverse events according to CTCAE v5.0 recorded at every patient visit in both arms.
- Treatment discontinuation and dose reduction rates in both arms.
- Reason for treatment discontinuation.
- HRQoL questionnaires (modified QLQ-C30, ELD-14, and selected items from the BR45 module) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms.
- Geriatric assessment tools (G8, iADL, ADL, Gait speed, CCI, social situation) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 18
PRD6503994 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/006
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503929 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503939 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/007
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503993 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/008
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 100 mg film-coated tablets
PRD7907867 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/012
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 125 mg film-coated tablets
PRD7907892 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/015
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 125 mg film-coated tablets
PRD7907865 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/014
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503927 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 100 mg film-coated tablets
PRD7907866 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/013
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503936 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 125 mg film-coated tablets
PRD8174770 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/018
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503998 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/009
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503933 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/004
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503996 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/005
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 75 mg film-coated tablets
PRD7907996 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/011
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 75 mg film-coated tablets
PRD7907995 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/010
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 100 mg film-coated tablets
PRD8174764 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/017
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IBRANCE 75 mg film-coated tablets
PRD8174762 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/016
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 5
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(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/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 600 mg/m2 milligram(s)/square meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(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
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 90 mg/m2 milligram(s)/square meter
- Max total dose
- 360 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(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 USE
- Max daily dose
- 80 mg/m2 milligram(s)/square meter
- Max total dose
- 960 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06391MIG · Substance
- Active substance
- Doxorubicin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 240 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
SUB07492MIG · Substance
- Active substance
- Exemestane
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05502MIG · Substance
- Active substance
- Anastrozole
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 3360 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10825MIG · Substance
- Active substance
- Tamoxifen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 67200 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08444MIG · Substance
- Active substance
- Letrozole
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 120 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
European Organisation For Research And Treatment Of Cancer
- Sponsor organisation
- European Organisation For Research And Treatment Of Cancer
- Address
- Emmanuel Mounierlaan 83 Bus 11
- City
- Sint-Lambrechts-Woluwe
- Postcode
- 1200
- Country
- Belgium
Scientific contact point
- Organisation
- European Organisation For Research And Treatment Of Cancer
- Contact name
- Stéphanie Kromar
Public contact point
- Organisation
- European Organisation For Research And Treatment Of Cancer
- Contact name
- Vassilis Golfinopoulos
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Solti Group ORG-100010708
|
Barcelona, Spain | On site monitoring, Other |
| GBG Forschungs GmbH ORG-100010508
|
Neu-Isenburg, Germany | On site monitoring, Other |
| Clinigen Clinical Supplies Management GmbH ORG-100016915
|
Schwalbach Am Taunus, Germany | Code 14 |
| UZ Leuven ORG-100006001
|
Leuven, Belgium | Laboratory analysis |
| Federation Nationale Des Centres De Lutte Contre Le Cancer ORG-100010034
|
Paris, France | On site monitoring, Other |
| Luxembourg Institute Of Health ORG-100028830
|
Dudelange, Luxembourg | Other |
| ETOP IBCSG Partners Foundation ORG-100010113
|
Bern, Switzerland | On site monitoring, Other |
Locations
7 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 56 | 7 |
| France | Ongoing, recruitment ended | 164 | 12 |
| Germany | Ongoing, recruitment ended | 30 | 6 |
| Italy | Ongoing, recruitment ended | 28 | 9 |
| Poland | Ongoing, recruitment ended | 2 | 1 |
| Portugal | Ongoing, recruitment ended | 7 | 2 |
| Spain | Ongoing, recruitment ended | 60 | 12 |
| Rest of world
United Kingdom, Jordan
|
— | 26 | — |
Investigational sites
UZ Leuven
Medical Oncology, Herestraat 49, 3000, Leuven
Vitaz
Medical Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
CHU De Liege
Medical Oncology, Avenue De L'hopital 1, 4000, Liege
Az Maria Middelares Gent
Medical Oncology, Buitenring-Sint-Denijs 30, 9000, Gent
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Heilig-Hartziekenhuis Lier
Medical Oncology, Mechelsestraat 24, 2500, Lier
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Centre Oscar Lambret
Medical Oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Jean Perrin
Medical Oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Centre Hospitalier Et Universitaire De Limoges
Medical Oncology, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Henri Becquerel
Medical Oncology, Rue D Amiens, 76038, Rouen Cedex
Centre Francois Baclesse
Medical Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Curie
Medical Oncology, 35 Rue Dailly, 92210, Saint-Cloud
Hospices Civils De Lyon
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
L'Hopital Prive Du Confluent
Clinical Oncology, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Hospices Civils De Lyon
Medical Oncology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Departemental Vendee
Medical Oncology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Klinikum Frankfurt Hoechst GmbH
Oncology, Gotenstrasse 6-8, Hoechst, Frankfurt Am Main
Kreiskrankenhaus Torgau Johann Kentmann gGmbH
Oncology, Christianistrasse 1, 04860, Torgau
Marien Hospital Witten
Oncology, Marienplatz 2, 58452, Witten
Studienzentrum Onkologie Ravensburg GmbH
Oncology, Elisabethenstrasse 19, 88212, Ravensburg
MKS St. Paulus GmbH
Oncology, Goethestrasse 19, 58239, Schwerte
KEM I Evang. Kliniken Essen-Mitte gGmbH
Oncology, Henricistrasse 92, Huttrop, Essen
Azienda Sanitaria Locale Della Provincia Di Biella
Medical oncology, Via Dei Ponderanesi 2, 13875, Ponderano
Azienda USL IRCCS Di Reggio Emilia
Oncology, Via Donatori Di Sangue 1, 42016, Guastalla
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
oncology, Corso Spezia 60, 10126, Turin
Azienda Unita Sanitaria Locale Della Romagna
Medical oncology, Viale Luigi Settembrini 2, 47923, Rimini
IRCCS Ospedale Policlinico San Martino
Department of Internal Medicine, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero Universitaria Delle Marche
oncology, Via Conca 71, 60126, Ancona
AUSL Modena - Ospedale B. Ramazzini
Medical oncology, Via Guido Molinari, 1-2, Carpi
Ospedale Mater Salutis Di Legnago
Medical oncology, Via Carlo Gianella 1, 37045, Legnago
Fondazione IRCCS San Gerardo Dei Tintori
Medical oncology, Via Giovanni Battista Pergolesi 33, 20900, Monza
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Breast Cancer and Reconstructive Surgery Clinic, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Medical oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Champalimaud Clinical Centre
Breast Cancer Unit, Avenida Brasilia S/n, 1400-038, Lisbon
Consorci Sanitari Del Maresme
Medical oncology, Carretera De Cirera 230, 08304, Mataro
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Severo Ochoa
Medical oncology, Avenida Orellana S/n, 28911, Leganes
Salut Sant Joan De Reus
Medical oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Fundacion Instituto Valenciano De Oncologia
Medical oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Clinico Universitario De Valencia
Medical oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Medical oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Medical oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Quironsalud Sagrado Corazon
Medical oncology, Calle De Rafael Salgado 3, 41013, Sevilla
MD Anderson Cancer Center
Medical oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
University Hospital Virgen Del Rocio S.L.
Medical oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Belgium | 2019-06-14 | 2019-09-26 | 2022-10-26 | ||
| France | 2019-08-30 | 2019-09-19 | 2022-10-26 | ||
| Germany | 2020-02-11 | 2020-03-02 | 2022-10-26 | ||
| Italy | 2020-03-10 | 2020-05-12 | 2022-10-26 | ||
| Poland | 2019-08-26 | 2021-02-05 | 2022-10-26 | ||
| Portugal | 2020-12-10 | 2021-03-02 | 2022-10-26 | ||
| Spain | 2020-01-14 | 2020-02-24 | 2022-10-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 84 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-505223-31-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol 2023-505223-31-00_summary of changes | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix J COVID-19_2023-505223-31 | 1 |
| Protocol (for publication) | D3_DSMB Charter 2023-505223-31_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 _IL15 Portuguese | 3 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 modified IL15 Spanish | 3 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 modified IL15 BE_Dutch | 3 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 modified IL15 BE_French | 3 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 modified IL15 DE_German | 3 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 modified IL15 FR_French | 3 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 modified IL15 Italian | 3 |
| Protocol (for publication) | D4_Patient facing documents QLQ-C30 modified IL15 Polish | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_1357 addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_1357_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_722_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_737_addendum_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_737_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_746_Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_746_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_824 _Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_824 addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_9102 addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC_9102_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum DE | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum ES | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum ES | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum FR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum FR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum IT | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum NL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum PL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum PL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum PT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum PT | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_French | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_German | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Polish | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_PT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_690_addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_690_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_699_addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_699_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_706_addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_706_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_722_addendum_reducted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Spanish | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dutch | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_French | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_French | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_German | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Polish | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PT | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Spanish_Redacted | 6 |
| Subject information and informed consent form (for publication) | L2_GP letter | 8.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_746_Redacted | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cyclophosphamide | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Docetaxel Seacross Rivopharm Limited | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorubicin Rivopharm Limited | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Epirubicin | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paclitaxel | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Palbociclib | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_Dutch 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_French 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_German 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE_German 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_lay language 2023-505223-31-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES_Spanish 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR_French 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_Italian 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL_lay language 2023-505223-31-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL_Polish 2023-505223-31 | 8.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PT_Portuguese 2023-505223-31 | 8.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-22 | Belgium | Acceptable 2024-02-20
|
2024-02-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-11 | Belgium | Acceptable 2024-12-02
|
2024-12-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-28 | Belgium | Acceptable 2025-08-25
|
2025-08-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-13 | Belgium | Acceptable 2025-08-25
|
2026-05-13 |