Clinical Trials /

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

NCT02492711

Description:

The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02492711

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Margetuximab</span> Plus <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> vs <span class="go-doc-concept go-doc-intervention">Trastuzumab</span> Plus <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> in the Treatment of <span class="go-doc-concept go-doc-biomarker">HER2</span>+ Metastatic <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
  • Official Title: A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-HER2 Therapies and Require Systemic Treatment

    • Clinical Trial IDs

    NCT ID: NCT02492711

    ORG ID: CP-MGAH22-04

    Trial Conditions

    HER-2 Positive Breast Cancer

    Metastatic Neoplasm

    Trial Interventions

    Drug Synonyms Arms
    Capecitabine Xeloda Margetuximab plus chemotherapy, Trastuzumab plus chemotherapy
    Eribulin Halaven Margetuximab plus chemotherapy, Trastuzumab plus chemotherapy
    Gemcitabine Gemzar Margetuximab plus chemotherapy, Trastuzumab plus chemotherapy
    Vinorelbine Navelbine Margetuximab plus chemotherapy, Trastuzumab plus chemotherapy

    Trial Purpose

    The purpose of this study is to determine whether patients treated with margetuximab plus
    chemotherapy have longer progression free survival and overall survival than patients
    treated with trastuzumab plus chemotherapy.

    Detailed Description

    An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by
    independent review and overall survival (OS), of margetuximab plus chemotherapy compared to
    trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have
    received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine in the
    neoadjuvant, adjuvant, or metastatic setting, and who have received at least one, and no
    more than two, lines of therapy in the metastatic setting.

    Trial Arms

    Name Type Description Interventions
    Margetuximab plus chemotherapy Experimental Margetuximab 15 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle Capecitabine, Eribulin, Gemcitabine, Vinorelbine
    Trastuzumab plus chemotherapy Active Comparator Trastuzumab 8 mg/kg loading dose then 6 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle Capecitabine, Eribulin, Gemcitabine, Vinorelbine

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast
    cancer. Tumors may be estrogen receptor (ER)/progesterone receptor (PR) positive or
    negative.

    - Prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the
    neoadjuvant, adjuvant, or metastatic setting. Prior radiotherapy and hormonal
    therapies are allowed.

    - Prior treatment for at least one, and no more than two, lines of therapy in the
    metastatic setting. Patients must have progressed on or following, the most recent
    line of therapy.

    - Resolution of all chemotherapy or radiation-related toxicities to Grade 1

    - Life expectancy 12 weeks

    - Acceptable laboratory parameters

    - Women of childbearing potential must have negative pregnancy test, and agree to use
    an effective form of contraception for the duration of study treatment and for 120
    days after the last dose of study drug

    Exclusion Criteria:

    - Known, untreated brain metastasis

    - History of uncontrolled seizures

    - Prior allogeneic bone marrow, stem-cell, or solid organ transplantation

    - History of clinically significant cardiovascular disease

    - Clinically-significant pulmonary compromise, including a requirement for supplemental
    oxygen use

    - Any condition that would be a contraindication to receiving trastuzumab as described
    in the approved local label or a condition that would prevent treatment with the
    protocol specified chemotherapies

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-free survival as determined by independent radiological review.

    Overall survival defined as the number of days from randomization to the date of death (from any cause).

    Secondary Outcome Measures

    To evaluate progression-free survival (PFS), as assessed by study investigators.

    To evaluate the objective response rate (ORR) as determined by independent radiological review.

    Trial Keywords