Clinical trial

A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

NCT01120184

Name

BO22589

Description

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

Trial arms

Trial start

2010-07-31

Estimated PCD

2014-09-30

Trial end

2016-09-16

Status

Completed

Phase

Early phase I

Treatment

docetaxel

75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.

Arms:

Trastuzumab + Taxane (docetaxel or paclitaxel)

paclitaxel

80 mg/m2 intravenously weekly for a minimum of 18 weeks

Arms:

Trastuzumab + Taxane (docetaxel or paclitaxel)

pertuzumab

840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles

Arms:

Trastuzumab emtansine + pertuzumab

pertuzumab-placebo

840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles

Arms:

Trastuzumab emtansine + pertuzumab placebo

trastuzumab [Herceptin]

trastuzumab \[Herceptin\] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.

Arms:

Trastuzumab + Taxane (docetaxel or paclitaxel)

trastuzumab emtansine

3.6 mg/kg intravenously every 3 weeks

Arms:

Trastuzumab emtansine + pertuzumab, Trastuzumab emtansine + pertuzumab placebo

Size

1095

Primary endpoint

Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment

Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)

Progression-Free Survival (PFS) According to IRF Assessment

Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)

Eligibility criteria

Inclusion Criteria: * Adult participants \>/=18 years of age * HER2-positive breast cancer * Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent. * Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Adequate organ function as determined by laboratory results Exclusion Criteria: * History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease * An interval of \<6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis * Hormone therapy \<7 days prior to randomization * Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) \<21 days prior to randomization * Prior trastuzumab emtansine or pertuzumab therapy

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1095, 'type': 'ACTUAL'}}

Updated at

2024-03-04

1 organization

7 products

1 drug

1 indication

Product

docetaxel

Indication

Breast Cancer

Organization

Hoffmann La Roche