Clinical Trials

The Breast Oncology Research Program is highlighting clinical trials of targeted and personalized experimental therapies for patients with metastatic breast cancer.

Referring Physicians/Healthcare Professionals:
If you have a patient you would like to refer for one of the following studies, or if you would like to talk with one of our physicians to learn more about these or other trials, please contact the principal investigator by calling M-LINE at 800-962-3555.

Breast Cancer Patients
If you are interested in any of the clinical trials below and would like to learn more, please contact our Cancer AnswerLine™ at 800-855-1125.

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HER2-Positive Metastatic Breast Cancer Clinical Trials

MM-302 and Herceptin vs. Chemotherapy of Physician’s Choice and Herceptin in Anthracycline Naïve Patients with Locally Advanced/Metastatic HER2-Positive Breast Cancer

Target: HER2      Drug: MM-302, an antibody-drug conjugated liposomal doxorubicin
Key eligibility:
  • No prior anthracycline
  • Progressed on or intolerant to prior pertuzumab and T-DMI
  • Previously treated with Herceptin
Trial design: Randomized to MM-302 vs. M.D. choice chemotherapy
PI: Monika Burness, M.D.
UMCC trial number and sponsor: UMCC 2014.079/Merrimack.
Learn more by reading the complete listing on UMClinicalStudies.org.

Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.

A Phase II Trial of HKI-272 (Neratinib) for Patients with HER2-Positive Breast Cancer and Brain Metastases

Target: HER2     Drug: Neratinib, an oral small molecular weight tyrosine kinase inhibitor of HER2
Key eligibility:
  • Progressive brain metastases
Trial design: Open label with 3 cohorts (pre-surgery, prior capecitabine and no prior capecitabine)
PI: Catherine Van Poznak, M.D.
UMCC trial number and sponsor: UMCC2012.034/TBCRC #22, Translational Breast Cancer Research Consortium and Puma Biotechnology.
Learn more by reading the complete listing on UMClinicalStudies.org.
Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.

Triple-Negative Metastatic Breast Cancer Clinical Trials

CDX-011 in Patients with Metastatic GPNMB Over-Expressing Triple-Negative Breast Cancer

Target: Glycoprotein non-metastatic melanoma protein B (GPNMB)     Drug: CDX-011, an antibody drug conjugate against GPNMB
Key eligibility:
  • Triple-negative metastatic breast cancer
  • Expresses GPNMB (tissue must be screened and confirmed by central laboratory)
  • Must have received prior anthracycline and taxane
  • No prior capecitabine
  • Measurable disease
Trial design: Randomized to CDX-011 vs. capecitabine
PI: Lynn Henry, M.D., Ph.D.
UMCC trial number and sponsor: UMCC 2014.007/Celldex.
Learn more by reading the complete listing on UMClinicalStudies.org.

Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.

Other Targeted Therapy Metastatic Breast Cancer Clinical Trials

BMN 673 vs M.D. Choice in Germline BRCA Mutation Patients with Metastatic Disease

Target: Poly (ADP-ribose) polymerase (PARP)     Drug: BMN673, a PARP inhibitor
Key eligibility:

  • Must have germline BRCA1/2 mutation
  • Triple-negative or ER-positive/HER2-negative
  • No more than 2 prior chemotherapies in the metastatic setting
  • No prior platin
Trial design: Randomized to single agent BMN673 vs. M.D. choice chemotherapy
PI: Lynn Henry, M.D., Ph.D.
UMCC trial number and sponsor: UMCC2013.102/BioMarin.
Learn more by reading the complete listing on UMClinicalStudies.org.

Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.

Phase II study of Neratinib in Metastatic HER2 Non-Amplified but HER2-Mutant Breast Cancer

Target: Mutated HER2     Drug: Neratinib, an oral small molecular weight tyrosine kinase inhibitor
Key eligibility:
  • Any metastases
  • HER2-negative (IHC 0-2+ and/or FISH negative)
  • Tissue must be screened and shown to contain HER2 mutations (either at U-M or by commercial NGS assay
Trial design: Single agent neratinib
PI: Daniel Hayes, M.D.
UMCC trial number and sponsor: UMCC 2013.055/Puma.
Learn more by reading the complete listing on UMClinicalStudies.org.

Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.

The following lists other breast cancer clinical trials available at the University of Michigan

Find a health research study that's right for you at UMClinicalStudies.org.

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