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Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
Not Recruiting
Trial ID: NCT02492711
Purpose
The purpose of this study is to determine whether patients with metastatic breast cancer
treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and
overall survival (OS) than patients treated with trastuzumab plus chemotherapy.
A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate
the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either
as monotherapy or in combination with chemotherapy.
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 Prior Anti-HER2 Therapies and Require Systemic Treatment
Stanford Investigator(s)
Mark Pegram
Susy Yuan-Huey Hung Professor
Eligibility
Inclusion Criteria:
- Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast
cancer based on the most recently available tumor biopsy collected from the patient.
Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
- Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic
setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line
of anti-HER2 directed therapy in the metastatic setting. In either case, patients must
have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic
setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are
allowed.
- Prior treatment with at least one, and no more than three, lines of therapy overall 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 performed within 14
days of randomization and on the first day of treatment. All subjects must agree to
use an effective form of contraception for the duration of study treatment and for 7
months after the last dose of study drug.
Infusion sub-study prior therapy requirements: Same as above, except:
- Must have received 4 or more prior lines or therapy in the metastatic setting
- Must have received prior trastuzumab, pertuzumab, and T-DM1
Exclusion Criteria:
- Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis
must have a CT or MRI performed within 4 weeks prior to randomization to specifically
exclude the presence of radiographically-detected brain metastases
- History of uncontrolled seizures within 6 months of randomization
- History of 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 to maintain adequate oxygenation
- 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
physician's choice of chemotherapy
Intervention(s):
biological: Margetuximab
biological: Trastuzumab
drug: Physician's choice of chemotherapy.
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061