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.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Prof. Wolfgang Janni · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	pertuzumab	HER2 targeted Therapy
DRUG	Trastuzumab	HER2 targeted Therapy
DRUG	Capecitabine	Chemotherapy
DRUG	Paclitaxel	Chemotherapy
DRUG	Vinorelbine	Chemotherapy
DRUG	Docetaxel	Chemotherapy
DRUG	Exemestane	endocrine therapy
DRUG	Letrozole	endocrine therapy
DRUG	Anastrozole	endocrine therapy
DRUG	Fulvestrant	endocrine therapy
DRUG	Ribociclib	CDK 4/6 inhibitor
DRUG	nab-Paclitaxel	chemotherapy
DRUG	eribulin	chemotherapy
DRUG	leuprorelin	endocrine therapy
DRUG	goserelin	endocrine therapy

Timeline

• Start date: 2015-09-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2015-01-26
• Last updated: 2024-06-04

Locations

1 site across 1 country: Germany