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.

Lead Sponsor:

MacroGenics

Stanford Investigator(s):

Intervention(s):

  • Biological: Margetuximab
  • Biological: Trastuzumab
  • Drug: Capecitabine
  • Drug: Eribulin
  • Drug: Gemcitabine
  • Drug: Vinorelbine

Phase:

Phase 3

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting