Status:
ACTIVE_NOT_RECRUITING
Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
Lead Sponsor:
Borstkanker Onderzoek Groep
Collaborating Sponsors:
Novartis
Philips Healthcare
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy fo...
Detailed Description
Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to...
Eligibility Criteria
Inclusion
- Postmenopausal women presenting with histological proven (core biopsy material) hormone receptor positive (ER≥50%, PR any), HER2 negative, stage II/ III breast cancer.
- Measurable disease (breast and/or lymph nodes)
- WHO 0-2
- Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
- Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min
- Accessible for treatment and follow-up
- Written informed consent
- Inclusion criteria randomization specific:
- In order to be eligible to be randomized in this study, a subject must meet all of the following criteria:
- Registration in the NEOLBC trial before 2 weeks biopsy
- Use of letrozole
- Outcome central Ki67 determination in two weeks biopsy available.
Exclusion
- Evidence of distant metastases (M1)
- Previous invasive breast cancer
- Prior chemotherapy, radiation therapy or hormonal therapy with the exception of patients who received letrozole ≤ 14 days (+ max. 4 days) prior to registration and who are still on letrozole.
- Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
- Peripheral neuropathy \> grade 2, whatever the cause
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \<50 at rest) or QTcF ≥450 msec.
- Known hypersensitivity reaction to any of the components of the treatment (peanuts, soy)
- Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
- Currently receiving any of the following substances and cannot be discontinued 7 days prior to randomisation:
- Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelo's, star-fruit, pomegranate and Seville oranges.
- That have a known risk to prolong the QT interval or induce Torsades de Pointes.
- That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- Herbal preparations/medications, dietary supplements.
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03283384
Start Date
June 15 2019
End Date
August 1 2027
Last Update
September 19 2025
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
2
Ziekenhuisgroep Twente
Almelo, Netherlands
3
Ziekenhuis Amstelland
Amstelveen, Netherlands
4
Nederlands Kanker Instituut - Antoni van Leeuwenhoek
Amsterdam, Netherlands