- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02344472
Detect V / CHEVENDO (Chemo vs. Endo)
DETECT V / CHEVENDO A Multicenter, Randomized Phase III Study to Compare 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Wolfgang Janni, MD PhD
- Phone Number: +49 731 500 58 501
- Email: studienzentrale.ufk@uniklinik-ulm.de
Study Contact Backup
- Name: Sabrina Krause, M. sc.
- Phone Number: +49 731 500 58 652
- Email: sabrina.krause@uniklinik-ulm.de
Study Locations
-
-
-
Ulm, Germany
- Recruiting
- University Hospital Ulm Gynecology/Obstetrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy with docetaxel
dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus docetaxel.
Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
|
Chemotherapy
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
|
Experimental: Chemotherapy with paclitaxel
dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus paclitaxel.Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
|
Chemotherapy
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
|
Experimental: Chemotherapy with vinorelbine
dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus vinorelbine.
Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
|
Chemotherapy
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
|
Experimental: Chemotherapy with capecitabine
dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus capecitabine.
Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
Chemotherapy
|
Experimental: endocrine therapy with exemestane
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane.
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
endocrine therapy
CDK 4/6 inhibitor
Other Names:
|
Experimental: endocrine therapy with fulvestrant
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant.
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
CDK 4/6 inhibitor
Other Names:
endocrine therapy
|
Experimental: endocrine therapy with anastrozole
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole.
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
CDK 4/6 inhibitor
Other Names:
endocrine therapy
|
Experimental: endocrine therapy with letrozole
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole.
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
CDK 4/6 inhibitor
Other Names:
endocrine therapy
|
Experimental: Chemotherapy with nab-Paclitaxel
dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus nab-Paclitaxel.
Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
chemotherapy
|
Experimental: Chemotherapy with eribulin
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus eribulin.
Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
chemotherapy
|
Experimental: endocrine therapy with leuprorelin
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin.
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
CDK 4/6 inhibitor
Other Names:
endocrine therapy
|
Experimental: endocrine therapy with goserelin
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin.
|
HER2 targeted Therapy
Other Names:
HER2 targeted Therapy
Other Names:
CDK 4/6 inhibitor
Other Names:
endocrine therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events
Time Frame: 3 - 9 weeks
|
safety of a dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (riobciclib) plus endocrine therapy as compared to a dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus chemotherapy (followed by endocrine therapy plus ribociclib in combination with trastuzumab and pertuzumab as maintenance therapy) by the proportion of patients experiencing any adverse event (as defined by the modified adverse event score)
|
3 - 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality-adjusted survival
Time Frame: 3 - 9 weeks
|
to assess quality-adjusted survival (as assessed by the Q-TWiST method) and to compare it between the two treatment arms
|
3 - 9 weeks
|
overall response rate (ORR)
Time Frame: 3 - 9 weeks
|
compare efficacy between the two treatment arms as assessed by overall response rate (ORR)
|
3 - 9 weeks
|
incidence of central nervous system (CNS) metastases and their control rate
Time Frame: 3 - 9 weeks
|
assess the incidence of CNS metastases and control rate of preexisting CNS metastases
|
3 - 9 weeks
|
Analysis of Quality of life
Time Frame: 3 - 9 weeks
|
assess additional aspects of quality of life based on the evaluation of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) QLQ-C30 and QLQ-BR23 questionnaires
|
3 - 9 weeks
|
presence and number of circulating tumor cell (CTC) at different time points
Time Frame: 6 weeks
|
determine presence and number of CTC in the peripheral blood at baseline and at different time points after the start of palliative treatment including the time of progression, and to assess the value of CTCs as indicator for therapy success
|
6 weeks
|
Evaluation of all reported events and all grades in both treatment arms (chemotherapy and endocrine therapy)
Time Frame: 3 - 9 weeks
|
All reported events with all grades for evaluation of safety and tolerability of the study treatments and to to evaluate and compare toxicity of chemotherapy arm vs. endocrine treatment arm
|
3 - 9 weeks
|
disease control rate (DCR)
Time Frame: 3 - 9 weeks
|
compare efficacy between the two treatment arms as assessed by disease control rate (DCR)
|
3 - 9 weeks
|
progression-free survival (PFS)
Time Frame: 3 - 9 weeks
|
compare efficacy between the two treatment arms as assessed by progression-free survival (PFS)
|
3 - 9 weeks
|
overall survival (OS)
Time Frame: 3 - 9 weeks
|
compare efficacy between the two treatment arms as assessed by overall survival (OS)
|
3 - 9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Huober, MD PhD, Studienzentrale Dpt. Gyn/OB University Ulm
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Docetaxel
- Paclitaxel
- Trastuzumab
- Capecitabine
- Letrozole
- Fulvestrant
- Leuprolide
- Goserelin
- Albumin-Bound Paclitaxel
- Vinorelbine
- Anastrozole
- Exemestane
- Pertuzumab
Other Study ID Numbers
- D-V
- 2014-002249-22 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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