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Detect V / CHEVENDO (Chemo vs. Endo)
Detect V / CHEVENDO (Chemo vs. Endo)
UnknownPhase 3
Sponsor: Prof. Wolfgang Janni
Conditions: Metastatic Breast Cancer
Interventions: pertuzumab, Trastuzumab, Capecitabine, Paclitaxel, Vinorelbine
Countries: Germany
Chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus Kisqali® (ribociclib) in patients with HER2 positive and hormone-receptor positive metastatic breast cancer.
Eligibility overview
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion criteria: * Signed, written informed consent in study participation * The primary tumor and/or biopsies from metastatic sites or locoregional recurrences have been confirmed as HER2-positive (FISH-positive or IHC 3+) and hormone receptor positive breast cancer by histopathology according to local testing * Metastatic breast cancer or locally advanced BC, which cannot be treated by surgery or radiotherapy only * Pre- and postmenopausal women are allowed * No more than two prior chemotherapies for metastatic disease * No more than two prior anti-HER2 therapies for metastatic disease * Pertuzumab retreatment is allowed if prior pertuzumab treatment was finished 12 months before * At least one measurable lesion assessable using standard techniques by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) * Tumor evaluation according to RECIST version 1.1 has been performed within 4 weeks before randomization based on local assessment * Age ≥ 18 years * Standard 12-lead ECG values assessed by the local laboratory: * QTcF interval at screening \< 450 msec (using Fridericia's correction) * Resting heart rate 50-90 bpm * Left ventricular cardiac ejection fraction (LVEF) ≥ 50% at baseline (as measured by echocardiogram) * ECOG Score ≤ 2 * Adequate organ function within 14 days before randomization, evidenced by the following laboratory results below: * absolute neutrophil count ≥ 1500 cells/µL, * platelet count ≥ 100000 cells/µL, * hemoglobin ≥ 9 g/dL, * ALT (SGPT) ≤ 2.0 × ULN (≤ 3.0 × ULN in case of liver metastases) * AST (SGOT) ≤ 2.0 × ULN (≤ 3.0 × ULN in case of liver metastases) * bilirubin ≤ 1.5 × ULN (with the exception of Gilbert's syndrome) * creatinine ≤ 2.0 mg/dl or 177µmol/L INR ≤ 1,5 * Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplemets before the first dose of study medication: * Sodium * Potassium * Total calcium * In case of patients of child bearing potential: Negative serum pregnancy test at baseline (within 7 days prior to randomization) and agreement to remain abstinent (if it is in line with the preferred and usual lifestyle) or use single or combined non-hormonal contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 7 months after the last dose of study treatment Exclusion criteria: Patients will be excluded from the study for any of the following reasons: * History of hypersensitivity reactions attributed to trastuzumab, pertuzumab, ribociclib or to other components of drug formulation * Mandatory need for cytostatic treatment at time of study entry based on clinical judgment and national/international treatment guidelines * Known CNS metastases * Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol * Progression on prior Pertuzumab therapy * Treatment with Pertuzumab within the last 12 months * Prior treatment with any mTOR- or CDK4/6-inhibitor * Treatment with any other investigational agents during trial * Known hypersensitivity to lecithin (soya) or peanuts * Life expectancy \< 6 months * Patients with pre-existing grade ≥2 peripheral neuropathy are excluded from taxane-based chemotherapy * History of serious cardiac disease, including but not confined to: * history of documented heart failure or systolic dysfunction (LVEF \< 50%) * high-risk uncontrolled arrhythmias i.e., atrial tachycardia with a heart rate ≥100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 \[Mobitz 2\] or third degree AV-block) * angina pectoris requiring anti-anginal medication * clinically significant valvular heart disease * evidence of transmural infarction on ECG * poorly controlled hypertension (e.g., systolic \>180 mm Hg or diastolic \>100 mm Hg) * any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient * Dyspnea at rest or other diseases that require continuous oxygen therapy * Patients with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications * Patients with known infection with HIV, hepatitis B virus, or hepatitis C virus * Male patients * Pregnant, lactating or women of childbearing potential without a negative pregnancy test (serum) within 7 days prior to randomization, irrespective of the method of contraception used * Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent * Participation in another clinical study within the 30 days before registration * Legal incapacity or limited legal capacity
Locations (1)
- Ulm, Germany