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.
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.
Active, not recruiting
Phase 3
NCT ID: NCT02492711
ORG ID: CP-MGAH22-04
HER-2 Positive Breast Cancer
Metastatic Neoplasm
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 |
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.
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.
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 |
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
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).
To evaluate progression-free survival (PFS), as assessed by study investigators.
To evaluate the objective response rate (ORR) as determined by independent radiological review.