Trial Search Results
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
This study will test whether patients with metastatic (having spread to distant organs beyond the breast or close by lymph nodes) or locally-advanced (cancer that hasn't spread but cannotbe cured by surgery) HER2-positive breast cancer that has worsened following standard treatments or lines of therapy will benefit from treatment with standard chemotherapy plus margetuximabcompared to standard chemotherapy plus trastuzumab (also called Herceptin). Both margetuximab and trastuzumab target cancer cells that make too much of a protein called human epidermal growth factor receptor 2, or HER2 which can turn a normal cell into a cancer cell and cause the cancer to grow faster. Cancers are called HER2+ if they are found to express too much HER2 using a test called "IHC" (immunohistochemistry) or another test called ISH (in situ hybridization). You are being considered for this study because your cancer has already been previously determined to be HER2+ by one or both of these tests.
Stanford is currently not accepting patients for this trial.
- Biological: Margetuximab
- Biological: Trastuzumab
- Drug: Capecitabine
- Drug: Eribulin
- Drug: Gemcitabine
- Drug: Vinorelbine
- 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
- 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study