Clinical Trials /

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

NCT02213744

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
MM-302MM-302 + trastuzumab
GemcitabineGemzarChemotherapy of Physician's Choice plus trastuzumab
CapecitabineXelodaChemotherapy of Physician's Choice plus trastuzumab
VinorelbineChemotherapy of Physician's Choice plus trastuzumab
TrastuzumabHerceptinMM-302 + 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

NameTypeDescriptionInterventions
MM-302 + trastuzumabExperimentalMM-302 + trastuzumab
  • MM-302
  • Trastuzumab
Chemotherapy of Physician's Choice plus trastuzumabActive ComparatorChemotherapy 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 4, 2017