Detect V / CHEVENDO (Chemo vs. Endo)

Sponsor
Prof. Wolfgang Janni
Study ID
NCT02344472
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2015
Status verified
Jun 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
271 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).
  • 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).
  • 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).
  • Experimental: endocrine therapy with exemestane
    dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane.
  • Experimental: endocrine therapy with fulvestrant
    dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant.
  • Experimental: endocrine therapy with anastrozole
    dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole.
  • Experimental: endocrine therapy with letrozole
    dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole.
  • 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).
  • 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).
  • Experimental: endocrine therapy with leuprorelin
    dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin.
  • Experimental: endocrine therapy with goserelin
    dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: 3 - 9 weeks ]

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