MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients

Conditions

• Breast Cancer
• HER2 Positive Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MM-302 — DRUG
• Gemcitabine — DRUG
• Capecitabine — DRUG
• Vinorelbine — DRUG
• Trastuzumab — DRUG

Study Details

This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

Key Dates

Start date

Jul 31, 2014

Status verified

Jan 2017

Primary completion

Dec 31, 2016

Completion

Jun 30, 2017

Study Design

Enrollment

113 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MM-302 + trastuzumab
  MM-302 + trastuzumab
• Active Comparator: Chemotherapy of Physician's Choice plus trastuzumab
  Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine

Primary Outcome Measure

Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately 2 years ]

Locations (70)

Find similar trials in Glendale, AZ

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