Description:
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.
Title
- Brief Title: MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
- Official Title: A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
MM-302-02-02-03
- NCT ID:
NCT02213744
Conditions
- Breast Cancer
- HER2 Positive Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
MM-302 | | MM-302 + trastuzumab |
Gemcitabine | Gemzar | Chemotherapy of Physician's Choice plus trastuzumab |
Capecitabine | Xeloda | Chemotherapy of Physician's Choice plus trastuzumab |
Vinorelbine | | Chemotherapy of Physician's Choice plus trastuzumab |
Trastuzumab | Herceptin | Chemotherapy of Physician's Choice plus trastuzumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
MM-302 + trastuzumab | Experimental | MM-302 + trastuzumab | |
Chemotherapy of Physician's Choice plus trastuzumab | Active Comparator | Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine | - Gemcitabine
- Capecitabine
- Vinorelbine
- Trastuzumab
|
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed invasive cancer of the
breast
- Patients must have documented locally advanced/metastatic disease, defined by the
investigator, which is not amenable to resection with curative intent.
- Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines
that is confirmed by a Sponsor-designated central laboratory
- Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC
setting or had disease recurrence within 12 months of pertuzumab treatment in the
neoadjuvant or adjuvant setting.
- Patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the
LABC/MBC setting
- Patients must have been previously treated with trastuzumab in any setting (which may
have been previously administered with or without pertuzumab)
- ECOG Performance Status of 0 or 1
Exclusion Criteria:
- Patients who have previously been treated with doxorubicin, liposomal doxorubicin,
epirubicin, mitoxantrone, or any other anthracycline derivative
- Subjects with central nervous system (CNS) metastases, unless they have been treated
and are stable without symptoms for 4 weeks after completion of treatment and must be
off steroids for at least 4 weeks prior to enrollment
- Patients with any class of New York Heart Association (NYHA) CHF or heart failure with
preserved ejection fraction (HFPEF)
- Patients with a history of known coronary artery disease or a myocardial infarction
within the last 12 months
- Patients with a known history of serious cardiac arrhythmias requiring treatment
(exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
- Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
- Patients with a history of LVEF decline to below 50% during or after prior
trastuzumab/lapatinib or other HER2 directed therapy.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Time to Treatment Failure |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate based on independent and investigator review of tumor assessments |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DoR) based on independent and investigator review of tumor assessments |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Safety |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm |
Measure: | Pharmacokinetic exposure of MM-302 |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | Area Under Curve (AUC) Time Frame: Cycles 1 and 2 - pre-infusion, post-infusion, and 168 hours post-dose. An optional timepoint at 8-96 hours post infusion is included during both cycles as well. |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Merrimack Pharmaceuticals |
Trial Keywords
- HER2-positive
- HER2+
- HER2
- Locally Advanced Breast Cancer
- Metastatic Breast Cancer
- trastuzumab
- Herceptin
- pertuzumab
- ado-trastuzumab emtansine
- TDM-1
- Perjeta
- Kadcyla
Last Updated
January 6, 2017