Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,050
Countries
1
Sites
69
Breast cancer
To evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free survival compared to treatment with a non-steroidal aromatase inhibitor in first line followed at progression by fu…
Key facts
- Sponsor
- BOOG Study Center B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Nov 2017 → ongoing
- Decision date (initial)
- 2024-11-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516204-42-00
- EudraCT number
- 2017-002334-23
- ClinicalTrials.gov
- NCT03425838
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free survival compared to treatment with a non-steroidal aromatase inhibitor in first line followed at progression by fulvestrant combined with CDK4/6 inhibition in second line (strategy B) in women with HR+/HER2- metastatic breast cancer who have not received any prior systemic anticancer therapy for metastatic disease.
Secondary objectives 12
- to compare overall survival (OS)
- to compare quality of life
- to compare safety and tolerability
- to compare objective response rate (ORR)
- to compare cost-effectiveness
- to determine alterations in genes, proteins, and (mi)RNAs in tumor tissues in order to select patients primary resistant to single agent first line endocrine therapy
- to determine circulating tumor DNA (ctDNA) in plasma before and during treatment, to investigate the prognostic and possibly predictive values of these measures
- to evaluate the predictive value of nuclear imaging for the benefit of CDK4/6 inhibitors
- to develop a limited sampling model for CDK4/6 inhibitors pharmacokinetics (PK), investigate the relationship between CDK4/6 inhibitors PK exposure and response (efficacy) and common side-effects
- to determine the prevalence of polymorphisms in CYP3A4 and SULT2A1
- to evaluate if there is a difference in cognitive functioning over time between patients with HR+/HER2- metastatic breast cancer who undergo first line treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition and patients who undergo first line treatment with single agent non-steroidal aromatase inhibitor
- to determine the prevalence of cognitive impairment in patients with HR+/HER2- metastatic breast cancer prior to treatment for metastatic disease and its relation with prior treatments.
Conditions and MedDRA coding
Breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 24.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with locoregional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated
- Documentation of histologically or cytologically confirmed diagnosis of estrogen receptor (ER) expression >10% and/or progesterone receptor (PR) expression >10% breast cancer based on local laboratory results. In case ER ≤ 10% and PR >10% the ER and PR expression need to be confirmed in a referral center. Tumor must be HER2-negative as defined by ASCO-CAP guidelines (9). If HER2 status is unavailable then testing must be performed/repeated prior to randomization.
- Previously untreated with any systemic anti-cancer therapy for metastatic HR+ disease, with the exception of recently started (within 28 days of randomization) endocrine therapy.
- Women who are not post-menopausal must receive ovarian ablation or suppression with administration of LHRH agonist.
- Evaluable disease as defined per RECIST v.1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Adequate organ and marrow function defined as follows: 1) ANC ≥1,000/mm3 (1.0 x 10e9 /L); 2) Platelets ≥50,000/mm3 (50 x 10e9 /L); 3) Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution; 4) Total serum bilirubin ≤1.5 x ULN (≤3.0 x ULN if Gilbert’s disease); 5) AST and ALT ≤3 x ULN (≤5.0 x ULN if liver metastases present);
- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1, except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion.
Exclusion criteria 10
- Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement).
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable without the use of steroids for at least 4 weeks before randomization
- Prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor (i.e. anastrozole or letrozole) with disease recurrence while on or within 12 months of treatment.
- Prior treatment with any CDK4/6 inhibitor.
- Patients treated within the last 7 days prior to randomization with: 1) Food or drugs that are known to be CYP3A4 inhibitors (ie, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit, pomegranate or grapefruit/pomegranate juice); 2) Drugs that are known to be CYP3A4 inducers (ie, carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentin, and St. John’s wort).
- Major surgery, chemotherapy, any investigational agents, or other anticancer therapy within 2 weeks before randomization. Palliative radiotherapy and/or (neo)adjuvant endocrine treatment within 2 weeks before randomization are allowed, provided that patients have recovered from these treatments. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received.
- Diagnosis of any other malignancy prior to randomization, except those that are not believed to influence the patient’s prognosis and do not require any further treatment. This includes, but is not limited to adequately treated basal cell or squamous cell skin cancer and carcinoma in situ of the cervix.
- QTc >480 msec at baseline
- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery that influences uptake of oral medication
- Known hypersensitivity to letrozole or anastrozole, or any of its excipients, or to any CDK4/6 inhibitors excipients.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival after two lines of treatment (PFS2) defined as time from randomization until one of the following (whichever occurs first): second objective disease progression or objective disease progression on second-line therapy, whichever occurs first, symptomatic deterioration on second-line therapy leading to discontinuation of second-line therapy initiation of chemotherapy for breast cancer or death
Secondary endpoints 11
- Overall survival
- Quality of life
- Safety and tolerability
- Objective response rate (ORR)
- Cost-effectiveness
- Type and incidence of grade 3 and 4 (serious) adverse events ((S)AE) (as graded by NCI CTCAE v4.0) and its relation to study medications.
- Tumor tissue biomarkers, including genes, proteins and (mi)RNA expression
- Circulating tumor DNA (ctDNA) in plasma
- Nuclear imaging, including FDG-PET and FES-PET
- Pharmacokinetics, -dynamics and -genomics of CDK4/6 inhibitors
- Cognitive functioning as assessed by validated online cognitive tests
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 15
Verzenios 100 mg film-coated tablets
PRD6705023 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/004
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 100 mg film-coated tablets
PRD6705027 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/013
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 50 mg film-coated tablets
PRD6705022 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/011
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 150 mg film-coated tablets
PRD6705032 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/015
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 50 mg film-coated tablets
PRD6701098 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 150 mg film-coated tablets
PRD6701108 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/007
- MA holder
- ELI LILLY NEDERLAND B.V.
- 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
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 100 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
PRD7907867 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 100 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
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
- 125 mg milligram(s)
- Max treatment duration
- 100 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
Kisqali 200 mg film-coated tablets
PRD5341550 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341552 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341551 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341538 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341543 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341542 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 100 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 6
SCP110317214 · ATC
- Active substance
- Estradiol Hemihydrate
- Substance synonyms
- Estra-1,3,5(10)-triene-3,17beta-diol hydrate (2:1), (17.BETA.)-ESTRA-1,3,5(10)-TRIENE-3,17-DIOL HEMIHYDRATE, oestradiol hemihydrate
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 3 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 3 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Estradiol with a radioactive label making the tracer 16-alpha-[18F]-17-beta-estradiol for diagnostics
—
SCP111850463 · ATC
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10.8 mg milligram(s)
- Max total dose
- 10.8 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE03 — GOSERELIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1154118 · ATC
- Active substance
- Letrozole
- Route of administration
- ORAL USE
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP15544179 · ATC
- Active substance
- Fulvestrant
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA03 — FULVESTRANT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP151923 · ATC
- Active substance
- Leuprorelin Acetate
- Substance synonyms
- LEUPROLIDE ACETATE
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 11.25 mg milligram(s)
- Max total dose
- 11.25 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE02 — LEUPRORELIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP136961 · ATC
- Active substance
- Anastrozole
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BOOG Study Center B.V.
- Sponsor organisation
- BOOG Study Center B.V.
- Address
- Moreelsepark 1
- City
- Utrecht
- Postcode
- 3511 EP
- Country
- Netherlands
Scientific contact point
- Organisation
- BOOG Study Center B.V.
- Contact name
- BOOG Study Center
Public contact point
- Organisation
- BOOG Study Center B.V.
- Contact name
- BOOG Study Center
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Amsterdam UMC Stichting ORG-100008355
|
Amsterdam, Netherlands | Code 11, Code 13 |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) ORG-100008976
|
Rotterdam, Netherlands | Code 11, Code 13, Laboratory analysis |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting ORG-100033850
|
Amsterdam, Netherlands | Code 10, Code 11, Code 13, Laboratory analysis |
| IKNL ORG-100022717
|
Utrecht, Netherlands | On site monitoring, Data management, E-data capture, Code 8 |
Locations
1 EU/EEA country · 69 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 1,050 | 69 |
| Rest of world | — | 0 | — |
Investigational sites
Diakonessenhuis Stichting
Oncology, Bosboomstraat 1, 3582 KE, Utrecht
Bernhoven B.V.
Internal medicine, Nistelrodeseweg 10, 5406 PT, Uden
Admiraal De Ruyter Ziekenhuis B.V.
Internal medicine / Oncology, 'S-Gravenpolderseweg 114, 4462 RA, Goes
Bravis Ziekenhuis
Oncology center, Boerhaavelaan 25, 4708 AE, Roosendaal
Stichting Amsterdam UMC
Medical Oncology, Meibergdreef 9, 1105 AZ, Amsterdam
Catharina Ziekenhuis Stichting
Oncology, Michelangelolaan 2, 5623 EJ, Eindhoven
Canisius Wilhelmina Ziekenhuis
Oncology-Hematology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Deventer Ziekenhuis
Medical Oncology / Oncology center Deventer, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Alrijne Zorggroep Stichting
Internal medicine, Simon Smitweg 1, 2353 GA, Leiderdorp
Albert Schweitzer Ziekenhuis
Oncology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Amphia Hospital
Oncology, Molengracht 21, 4818 CK, Breda
Zuyderland Medisch Centrum Stichting
Oncology, Henri Dunantstraat 5, 6419 PC, Heerlen
Treant Ziekenhuiszorg Stichting
Internal medicine, Boermarkeweg 60, 7824 AA, Emmen
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Ziekenhuis Amstelland
Oncology, Laan Van De Helende Meesters 8, 1186 AM, Amstelveen
Ziekenhuisgroep Twente Stichting
Oncology center, Zilvermeeuw 1, 7609 PP, Almelo
ZorgSaam Ziekenhuis
Oncology, Wielingenlaan 2, 4535 PA, Terneuzen
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Internal medicine / Oncology, Tegelseweg 210, 5912 BL, Venlo
Ziekenhuis St Jansdal
Oncology, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Zaans Medisch Centrum Stichting
Oncology, Koningin Julianaplein 58, 1502 DV, Zaandam
Het Van Weel-Bethesda Ziekenhuis
Oncology, Stationsweg 22, 3247 BW, Dirksland
Wilhelmina Ziekenhuis Assen
Oncology, Europaweg-Zuid 1, 9401 RK, Assen
Laurentius Ziekenhuis Roermond
Internal medicine, Monseigneur Driessenstraat 6, 6043 CV, Roermond
IJsselland Ziekenhuis
Oncology, Prins Constantijnweg 2, 2906 ZC, Capelle Aan Den Ijssel
Maasstad Ziekenhuis Stichting
Oncology, Maasstadweg 21, 3079 DZ, Rotterdam
Ikazia Ziekenhuis
Oncology, Montessoriweg 1, 3083 AN, Rotterdam
Stichting OLVG
Internal medicine / Oncology, Oosterpark 9, 1091 AC, Amsterdam
Medisch Centrum Leeuwarden B.V.
Oncology center Leeuwarden, Henri Dunantweg 2, 8934 AD, Leeuwarden
Stichting Radboud universitair medisch centrum
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Medisch Spectrum Twente
Internal medicine, Koningsplein 1, 7512 KZ, Enschede
Noordwest Ziekenhuisgroep Stichting
Internal medicine / Oncology, Wilhelminalaan 12, 1815 JD, Alkmaar
Maxima Medisch Centrum
Oncology, Ds Theodor Fliednerstraat 1, 5631 BM, Eindhoven
Haga Hospital
Internal medicine, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Leids Universitair Medisch Centrum (LUMC)
Oncology, Albinusdreef 2, 2333 ZA, Leiden
Beatrix Ziekenhuis
Oncology, Banneweg 57, 4204 AA, Gorinchem
Jeroen Bosch Ziekenhuis Stichting
Oncology, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Stichting Martini Ziekenhuis
Internal medicine, Van Swietenplein 1, 9728 NT, Groningen
Ziekenhuis Nij Smellinghe
Oncology, Compagnonsplein 1, 9202 NN, Drachten
Gelre Hospitals
Internal medicine, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Haaglanden Medisch Centrum Stichting
Oncology, Burgemeester Banninglaan 1, 2262 BA, Leidschendam
Reinier de Graaf Groep
Oncology, Reinier De Graafweg 5, 2625 AD, Delft
Groene Hart Ziekenhuis
Internal medicine / Oncology-Hematology, Bleulandweg 10, 2803 HH, Gouda
Meander Medisch Centrum Stichting
Oncology, Maatweg 3, 3813 TZ, Amersfoort
Rijnstate Ziekenhuis Stichting
Internal medicine, Wagnerlaan 55, 6815 AD, Arnhem
Isala Klinieken Stichting
Oncology center, Dokter Van Heesweg 2, 8025 AB, Zwolle
Ziekenhuis Gelderse Vallei Stichting
Oncology center, Willy Brandtlaan 10, 6716 RP, Ede Gld
Sint Franciscus Vlietland Groep Stichting
Oncology, Vlietlandplein 2, 3118 JH, Schiedam
Dijklander Ziekenhuis
Oncology, Maelsonstraat 3, 1624 NP, Hoorn Nh
Elkerliek Ziekenhuis
Oncology-Hematology, Wesselmanlaan 25, 5707 HA, Helmond
Flevoziekenhuis Stichting
Internal medicine, Hospitaalweg 1, 1315 RA, Almere
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Stichting Elisabeth-Tweesteden Ziekenhuis
Oncology-Hematology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Ziekenhuis Rivierenland
Internal medicine / Oncology, President Kennedylaan 1, 4002 WP, Tiel
Tergooiziekenhuizen
Internal medicine, Laan Van Tergooi 2, 1212 VG, Hilversum
Sint Antonius Ziekenhuis Stichting
Internal medicine, Koekoekslaan 1, 3435 CM, Nieuwegein
Slingeland Ziekenhuis
Internal medicine, Kruisbergseweg 25, 7009 BL, Doetinchem
Rode Kruis Ziekenhuis B.V.
Internal medicine, Vondellaan 13, 1942 LE, Beverwijk
Streekziekenhuis Koningin Beatrix
Oncology, Beatrixpark 1, 7101 BN, Winterswijk
Stichting St. Anna Zorggroep
Internal medicine, Bogardeind 2, 5664 EH, Geldrop
Spaarne Gasthuis Stichting
Oncology, Spaarnepoort 1, 2134 TM, Hoofddorp
Saxenburgh Medisch Centrum
Internal medicine, Jan Weitkamplaan 4a, 7772 SE, Hardenberg
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Internal medicine, Plesmanlaan 121, 1066 CX, Amsterdam
Maasziekenhuis Pantein B.V.
Oncology, Dokter Kopstraat 1, 5835 DV, Beugen
Tjongerschans B.V.
Internal medicine, Thialfweg 44, 8441 PW, Heerenveen
Alexander Monro Ziekenhuis Stichting
Internal medicine, Professor Bronkhorstlaan 10 G 94, 3723 MB, Bilthoven
Antonius Ziekenhuis Sneek
Interne Geneeskunde, Bolswarderbaan 1, 8601 ZK, Sneek
Stichting BovenIJ
Interne Geneeskunde, Statenjachtstraat 1, 1034 CS, Amsterdam
SJG Weert
Interne Geneeskunde, Vogelsbleek 5, 6001BE, Weert
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 |
|---|---|---|---|---|---|
| Netherlands | 2017-11-21 | 2017-11-21 | 2021-09-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516204-42 public | 1.11 |
| Recruitment arrangements (for publication) | Blank document | x |
| Subject information and informed consent form (for publication) | L1_SIS and ICF public | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SONIA EfFECT side study public | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Anastrozole | x |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fulvestrant | x |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Goserelin | x |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ibrance palbociclib | x |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Kisqali ribociclib | x |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Letrozole | x |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Leuprorelin | x |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Verzenios abemaciclib | x |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Netherlands | Acceptable 2024-11-12
|
2024-11-12 |