Tailoring neoadjuvant therapy in hormone receptor positive, HER2 negative, luminal breast cancer.
- Conditions
- Breast cancermamma carcinoma10006291
- Registration Number
- NL-OMON54665
- Lead Sponsor
- BOOG Study Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
• 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>=3.0x10^9/l, neutrophils >=1.5 x 10^9/l, platelets >=100 x 10^9/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
Randomization specific:
• Registration in the NEOLBC trial before 2 weeks biopsy
• Use of letrozole
• Outcome central Ki67 determination in two weeks biopsy available.
• 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:
o Known strong inducers or inhibitors of CYP3A4/5, including grapefruit,
grapefruit hybrids, pummelos, star-fruit, pomegranate and Seville oranges.
o That have a known risk to prolong the QT interval or induce Torsades de
Pointes.
o That have a narrow therapeutic window and are predominantly metabolized
through CYP3A4/5.
o 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in CCCA (defined as Ki67 IHC <1%) between ribociclib plus letrozole<br /><br>and chemotherapy in the surgical specimen*. </p><br>
- Secondary Outcome Measures
Name Time Method