Detect V / CHEVENDO (Chemo vs. Endo)

NCT02344472 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: D-V2014-002249-22
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer

Keywords

MBC; HER2; CTC; endocrine therapy; Pertuzumab; Trastuzumab; HER2 therapy; Ribociclib

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  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 Outcomes (9)

• quality-adjusted survival

  3 - 9 weeks

• overall response rate (ORR)

  3 - 9 weeks

• incidence of central nervous system (CNS) metastases and their control rate

  3 - 9 weeks

• Analysis of Quality of life

  3 - 9 weeks

• presence and number of circulating tumor cell (CTC) at different time points

  6 weeks

Study Arms (12)

Chemotherapy with docetaxel

EXPERIMENTAL

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).

Drug: pertuzumab; Drug: Trastuzumab; Drug: Docetaxel

Chemotherapy with paclitaxel

EXPERIMENTAL

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).

Drug: pertuzumab; Drug: Trastuzumab; Drug: Paclitaxel

Chemotherapy with vinorelbine

EXPERIMENTAL

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).

Drug: pertuzumab; Drug: Trastuzumab; Drug: Vinorelbine

Chemotherapy with capecitabine

EXPERIMENTAL

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).

Drug: pertuzumab; Drug: Trastuzumab; Drug: Capecitabine

endocrine therapy with exemestane

EXPERIMENTAL

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane.

Drug: pertuzumab; Drug: Trastuzumab; Drug: Exemestane; Drug: Ribociclib

endocrine therapy with fulvestrant

EXPERIMENTAL

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant.

Drug: pertuzumab; Drug: Trastuzumab; Drug: Fulvestrant; Drug: Ribociclib

endocrine therapy with anastrozole

EXPERIMENTAL

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole.

Drug: pertuzumab; Drug: Trastuzumab; Drug: Anastrozole; Drug: Ribociclib

endocrine therapy with letrozole

EXPERIMENTAL

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole.

Drug: pertuzumab; Drug: Trastuzumab; Drug: Letrozole; Drug: Ribociclib

Chemotherapy with nab-Paclitaxel

EXPERIMENTAL

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).

Drug: pertuzumab; Drug: Trastuzumab; Drug: nab-Paclitaxel

Chemotherapy with eribulin

EXPERIMENTAL

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).

Drug: pertuzumab; Drug: Trastuzumab; Drug: eribulin

endocrine therapy with leuprorelin

EXPERIMENTAL

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin.

Drug: pertuzumab; Drug: Trastuzumab; Drug: Ribociclib; Drug: leuprorelin

endocrine therapy with goserelin

EXPERIMENTAL

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin.

Drug: pertuzumab; Drug: Trastuzumab; Drug: Ribociclib; Drug: goserelin

Interventions

pertuzumab DRUG

HER2 targeted Therapy

Also known as: Perjeta®

Chemotherapy with capecitabine; Chemotherapy with docetaxel; Chemotherapy with eribulin; Chemotherapy with nab-Paclitaxel; Chemotherapy with paclitaxel; Chemotherapy with vinorelbine; endocrine therapy with anastrozole; endocrine therapy with exemestane; endocrine therapy with fulvestrant; endocrine therapy with goserelin; endocrine therapy with letrozole; endocrine therapy with leuprorelin

Trastuzumab DRUG

HER2 targeted Therapy

Also known as: Herceptin®

Chemotherapy with capecitabine; Chemotherapy with docetaxel; Chemotherapy with eribulin; Chemotherapy with nab-Paclitaxel; Chemotherapy with paclitaxel; Chemotherapy with vinorelbine; endocrine therapy with anastrozole; endocrine therapy with exemestane; endocrine therapy with fulvestrant; endocrine therapy with goserelin; endocrine therapy with letrozole; endocrine therapy with leuprorelin

Capecitabine DRUG

Chemotherapy

Chemotherapy with capecitabine

Paclitaxel DRUG

Chemotherapy

Chemotherapy with paclitaxel

Vinorelbine DRUG

Chemotherapy

Chemotherapy with vinorelbine

Docetaxel DRUG

Chemotherapy

Chemotherapy with docetaxel

Exemestane DRUG

endocrine therapy

endocrine therapy with exemestane

Letrozole DRUG

endocrine therapy

endocrine therapy with letrozole

Anastrozole DRUG

endocrine therapy

endocrine therapy with anastrozole

Fulvestrant DRUG

endocrine therapy

endocrine therapy with fulvestrant

Ribociclib DRUG

CDK 4/6 inhibitor

Also known as: Kisqali®

endocrine therapy with anastrozole; endocrine therapy with exemestane; endocrine therapy with fulvestrant; endocrine therapy with goserelin; endocrine therapy with letrozole; endocrine therapy with leuprorelin

nab-Paclitaxel DRUG

chemotherapy

Chemotherapy with nab-Paclitaxel

eribulin DRUG

chemotherapy

Chemotherapy with eribulin

leuprorelin DRUG

endocrine therapy

endocrine therapy with leuprorelin

goserelin DRUG

endocrine therapy

endocrine therapy with goserelin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof. Wolfgang Janni: lead
• Roche Pharma AG: collaborator
• Novartis Pharmaceuticals: collaborator
• Eisai GmbH: collaborator
• Celgene Corporation: collaborator

Study Sites (1)

University Hospital Ulm Gynecology/Obstetrics

Ulm, Germany

Location

Related Links

• The DETECT study concept

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab; Trastuzumab; Capecitabine; Paclitaxel; Vinorelbine; Docetaxel; exemestane; Letrozole; Anastrozole; Fulvestrant; ribociclib; 130-nm albumin-bound paclitaxel; eribulin; Leuprolide; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Nitriles; Triazoles; Azoles; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins

Study Officials

• Jens Huober, MD PhD

  Studienzentrale Dpt. Gyn/OB University Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 11, 2015
• First Posted: January 26, 2015
• Study Start: September 1, 2015
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

DE (1)