Detect V / CHEVENDO (Chemo vs. Endo)

  • STATUS
    Recruiting
  • End date
    Jun 23, 2023
  • participants needed
    270
  • sponsor
    Prof. W. Janni
Updated on 24 January 2022
platelet count
paclitaxel
serum pregnancy test
measurable disease
breast cancer
endocrine therapy
metastasis
neutrophil count
hormone therapy
capecitabine
pertuzumab
liver metastasis
HER2
primary tumor
trastuzumab
goserelin
fulvestrant
herceptin
anastrozole
vinorelbine
exemestane
letrozole
eribulin

Summary

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.

Description

Especially for diseases that are not curable such as metastatic breast cancer (MBC), the maintenance of quality of life is one of the main aims of treatments. Adverse events are well-known side effects of any cytostatic treatment and impact the patients' quality of life. Therefore, new treatment options are developed that should stop or at least slow down metastatic spread of cancer without causing negative side effects in terms of high-grade adverse events. For patients with hormone-receptor positive and HER2 positive MBC the combination of HER2-targeted therapy with endocrine therapy has already been proven to be an effective and in many cases valuable alternative to the combination of HER2-targeted therapy with chemotherapy. The high relevance of HER2-neu-targeted/endocrine treatment combinations derives from the fact that potential chemotherapy-related toxicity can be avoided, which in turn positively affects quality of life. Clinical trials suggest an additional benefit when a CDK4/6 inhibitor is added to the combination of endocrine therapy and anti HER2 treatment. DETECT V is a randomized phase III study comparing the safety and efficacy of trastuzumab plus pertuzumab and the CDK 4/6 inhibitor ribociclib in combination with either endocrine therapy or chemotherapy.

Details
Condition Metastatic Breast Cancer
Treatment Capecitabine, docetaxel, Paclitaxel, Trastuzumab, Letrozole, Nab-paclitaxel, Eribulin, Vinorelbine, Ribociclib, Goserelin, tamoxifen, anastrozole, exemestane, fulvestrant, Pertuzumab, Leuprorelin
Clinical Study IdentifierNCT02344472
SponsorProf. W. Janni
Last Modified on24 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Signed, written informed consent in study participation
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)
Age 18 years
Tumor evaluation according to RECIST version 1.1 has been performed within 4 weeks before randomization based on local assessment
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
Standard 12-lead ECG values assessed by the local laboratory
QTcF interval at screening < 450 msec (using Fridericia's correction)
absolute neutrophil count 1500 cells/L
Resting heart rate 50-90 bpm
platelet count 100000 cells/L
hemoglobin 9 g/dL
bilirubin 1.5 ULN (with the exception of Gilbert's syndrome)
In case of patients of child bearing potential
Negative serum pregnancy test at baseline (within 7 days prior to
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)
randomization) and agreement to remain abstinent (if it is in line with the
preferred and usual lifestyle) or use single or combined non-hormonal
creatinine 2.0 mg/dl or 177mol/L INR 1,5
contraceptive methods that result in a failure rate of < 1% per year during
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
the treatment period and for at least 7 months after the last dose of study
Sodium
treatment
Potassium
Total calcium

Exclusion Criteria

Patients will be excluded from the study for any of the following reasons
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
Treatment with any other investigational agents during trial
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)
History of hypersensitivity reactions attributed to trastuzumab, pertuzumab, ribociclib or to other components of drug formulation
angina pectoris requiring anti-anginal medication
Mandatory need for cytostatic treatment at time of study entry based on clinical judgment and national/international treatment guidelines
clinically significant valvular heart disease
Known CNS metastases
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
Progression on prior Pertuzumab therapy
Dyspnea at rest or other diseases that require continuous oxygen therapy
Treatment with Pertuzumab within the last 12 months
Patients with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications
Prior treatment with any mTOR- or CDK4/6-inhibitor
Patients with known infection with HIV, hepatitis B virus, or hepatitis C virus
Male patients
Known hypersensitivity to lecithin (soya) or peanuts
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
Life expectancy < 6 months
Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
Patients with pre-existing grade 2 peripheral neuropathy are excluded from taxane-based chemotherapy
Participation in another clinical study within the 30 days before registration
Legal incapacity or limited legal capacity
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