Detect V / CHEVENDO (Chemo vs. Endo)

  • STATUS
    Recruiting
  • End date
    Nov 8, 2024
  • participants needed
    270
  • sponsor
    Prof. W. Janni
Updated on 8 August 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 on8 August 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
Signed, written informed consent in study participation
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
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)
Resting heart rate 50-90 bpm
Left ventricular cardiac ejection fraction (LVEF) ≥ 50% at baseline (as measured by
echocardiogram)
ECOG Score ≤ 2
absolute neutrophil count ≥ 1500 cells/µL
In case of patients of child bearing potential
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
Sodium
Patients must have the following laboratory values within normal limits or corrected
Potassium
to within normal limits with supplemets before the first dose of study
Total calcium
medication
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
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%)
angina pectoris requiring anti-anginal medication
clinically significant valvular heart disease
evidence of transmural infarction on ECG
Known CNS metastases
History of hypersensitivity reactions attributed to trastuzumab, pertuzumab
ribociclib or to other components of drug formulation
Progression on prior Pertuzumab therapy
Mandatory need for cytostatic treatment at time of study entry based on clinical
Dyspnea at rest or other diseases that require continuous oxygen therapy
Treatment with Pertuzumab within the last 12 months
judgment and national/international treatment guidelines
Prior treatment with any mTOR- or CDK4/6-inhibitor
Patients with known infection with HIV, hepatitis B virus, or hepatitis C virus
Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition
Male patients
Known hypersensitivity to lecithin (soya) or peanuts
that might interfere with the planned treatment and with the patient's adherence to
Life expectancy < 6 months
the protocol
Participation in another clinical study within the 30 days before registration
Legal incapacity or limited legal capacity
Patients with pre-existing grade ≥2 peripheral neuropathy are excluded from
taxane-based chemotherapy
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)
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
Patients with poorly controlled diabetes or with evidence of clinically significant
diabetic vascular complications
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
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