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Clinical Trials

The Breast Oncology Research Program is highlighting clinical trials of targeted and personalized experimental therapies for patients with 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 800-865-1125.

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Triple-Negative Metastatic Breast Cancer Clinical Trials

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Paclitaxel in Combination with Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple-Negative Breast Cancer

    Target: CXC ligand 8
    Drug: Reparixin, an inhibitor of CXC ligand 8
    Key eligibility:
    • No prior treatment for metastatic disease; must have had prior chemotherapy for early stage breast cancer
    • Measurable disease
    • No brain metastases
    Trial design: double-blind, placebo controlled
    PI: Anne Schott, M.D.
    UMCC trial number and sponsor: UMCC 2015.049; DOMPE.

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

 

A phase Ib/II trial of taselisib (GDC-0032), a PI3K inhibitor, in combination with enzalutamide in patients with androgen receptor positive triple negative metastatic breast cancer

    Target: androgen receptor and TNBC
    Drug:GDC-0032
    Key eligibility:
    • Open to men and women
    • Stage IV invasive mammary carcinoma
    • Must not be taking/undergoing Enzalutamide
    • No brain metastases
    Trial design: Open label, open-label phase Ib/II multiple institution trial
    PI: Catherine Van Poznak, M.D.
    UMCC trial number: UMCC 2015.125.

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

 

A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic

    Target: CYP17
    Drug: VT-464
    Key eligibility:
    • No prior treatment for metastatic disease; must have had prior chemotherapy for early stage breast cancer
    • for Phase 2: AR(+) TNBC or ER(+) HER2 normal breast cancer
    • No symptomatic CNS metastases
    Trial design: non-randomized, open-label
    PI: Catherine Van Poznak, M.D.
    UMCC trial number: UMCC 2015.161.

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

 

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-188 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

    Target: BRCA-mutated breast cancer
    Drug: Cisplatin with or without ABT-888
    Key eligibility:
    • Must have had at least one prior cytotoxic regimen for metatstatic disease
    • Measurable disease
    • Able to swallow capsules
    Trial design: randomized, placebo-controlled
    PI: Anne Schott, M.D.
    UMCC trial number: SWOG S1416.

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

 

A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

    Key eligibility:
    • Must have estrogen, progesterone, and HER2 status of either primary tumor or metastasis
    • Confirmed metastatic breast cancer
    • No brain metastases
    Trial design: randomized
    PI: Reshma Jagsi, M.D., DPhil
    UMCC trial number and sponsor: NRG-BR002; NRG Oncology.

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

HER2-Positive Metastatic Breast Cancer Clinical Trials

A Phase 1 Multi-Center Trial of Trastuzumab and Pertuzumab in Combination with Tocilizumab in Subjects with Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab

    Target: IL-6R
    Drug: Trastuzumab and Pertuzumab with Tocilizumab
    Key eligibility:
    • Must have confirmed HER2 breast cancer that is metastatic or locally advanced
    • Must have received trastuzumab and had progression on trastuzumab
    • Must be able to tolerate trastuzumab and pertuzumab therapy.
    • No history of decreased ejection fraction due to trastuzumab or pertuzumab
    Trial design: Phase 1 dose-escalation
    PI: Monika Burness, M.D.
    UMCC trial number and sponsor: UMCC 2017.002; Genentech.

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

 

A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

    Key eligibility:
    • Must have estrogen, progesterone, and HER2 status of either primary tumor or metastasis
    • Confirmed metastatic breast cancer
    • No brain metastases
    Trial design: randomized
    PI: Reshma Jagsi, M.D., DPhil
    UMCC trial number and sponsor: NRG-BR002; NRG Oncology.

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

ER-Positive, HER2-Negative Metastatic Disease

A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Radium-223 Dichloride in Combination with Exemestane and Everolimus vs. Placebo in Combination with Exemestane and Everolimus when Administered to Metastatic HER2-negative, Hormone Receptor Positive Breast Cancer Subjects with Bone Metastases

    Target: bone targeting alpha particle emitting radiopharmaceutical
    Drug: radium-223 dichloride
    Key eligibility:
    • Must have received at least 1 line of treatment with hormone therapy for metastatic breast cancer; no prior chemotherapy in metastatic setting
    • Bone dominant (at least 2 lesions), with at least one but no more than two skeletal-related events (e.g., fracture, palliative radiation); may also have soft tissue or visceral metastases
    • Measurable or non-measurable disease
    • Inflammatory breast cancer excluded
    Trial design: double-blind, placebo controlled
    PI: Catherine Van Poznak, M.D.
    UMCC trial number and sponsor: UMCC 2014.085; Bayer.

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

 

Palbociclib in Combination with Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer with Prior Chemotherapy for Advanced Disease: A Phase II study with Pharmacodynamics Markers

    Target: CYP17
    Drug: Seviteronel
    Key eligibility:
    • Must have ER+/HER2 or TNBC
    • Measurable disease
    • No symptomatic CNS metastases
    Trial design:interventional, non-randomized
    PI: Catherine Van Poznak, M.D.
    UMCC trial number: UMCC 2015.167.

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

 

A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

    Key eligibility:
    • Must have estrogen, progesterone, and HER2 status of either primary tumor or metastasis
    • Confirmed metastatic breast cancer
    • No brain metastases
    Trial design: randomized
    PI: Reshma Jagsi, M.D., DPhil
    UMCC trial number and sponsor: NRG-BR002; NRG Oncology.

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

Brain Metastases

A Pilot Study in Patients Treated with MM-398 to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

    Target:ER and/or PR-positive breast cancer; or TNBC
    Drug: MM-398
    Key eligibility:
    • Metastatic breast cancer
    • No CNS metastases
    • Must be able to undergo MRI
    PI: Aki Morikawa, M.D.
    UMCC trial number and sponsor: UMCC2016.033; Merrimack Pharmaceuticals, Inc.

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

 

A Phase 2 Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer

    Target: CDK4/6 pathway
    Drug: Abemaciclib, a CDK4/6 inhibitor
    Key eligibility:
    • Parts A & B: 1 or more new or not previously irradiated measurable brain lesion >1 mm or progressing previously irradiated.
    • Part C: 1-3 brain lesions for which surgical resection is clinically indicated
    • Completed local therapy at least 14 days prior to initiating abemaciclib
    • Stable or decreasing dose of corticosteroids for at least 7 days prior to baseline
    • No prior treatment with CDK4/6 inhibitor
    • Leptomeningeal disease permitted
    Trial design: Single agent Abemaciclib
    PI: Aki Morikawa, M.D.
    UMCC trial number and sponsor: UMCC2015.012; Eli Lilly.

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

 

A Phase 1 Dose-Escalation Study of RRx-001 in Combination with Whole Brain Radiation in Subjects with Brain Metastases

    Target: Brain Metastases
    Drug: RRx-001
    Key eligibility:
    • Must have one brain metastases
    • No prior whole brain radiotherapy
    • No prior RRx-001 therapy
    Trial design: Interventional, Dose-escalation study
    PI: Michelle Kim, M.D.
    UMCC trial number and sponsor: UMCC 2014.042; Eli Lilly,

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

 

Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer

    Target: Brain Metastases from HER2+ breast cancer
    Drug: Lapatinib
    Key eligibility:
    • HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification
    • Must have one measurable brain metastases
    • No prior radiation therapy
    Trial design: Randomized
    PI: James Hayman, M.D.
    UMCC trial number and sponsor: RTOG-1119; National Cancer Institute.

    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

Molecular Analysis for Therapy Choice (MATCH)

    National Cancer Institute-Molecular Analysis for Therapy Choice, known as NCI-MATCH or study EAY131, is a phase II precision medicine trial that seeks to determine whether matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type.
    Key eligibility:

    • Must have measurable disease
    • Must not currently be receiving any other investigational agents
    PI: Ajjai Alva, MBBS
    UMCC trial number: ECOG-ACRIN EAY131.

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

 

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study

    The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
    Key eligibility:

    • Must have measurable disease
    • No brain metastases
    PI: Ajjai Alva, MBBS
    UMCC trial number: UMCC 2016.004.

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


Triple-Negative Early Stage Disease

Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer

    Target: TNBC
    Drug: Pembrolizumab
    Key eligibility:
    • Must have confirmed ER-, PR- and HER2-negative (triple negative, TNBC)
    • Must have residual, invasive disease after completion of chemotherapy
    • Measurable disease
    • No brain metastases
    Trial design: randomized, phase III
    PI: Anne Schott, M.D.
    UMCC trial number: SWOG S1418.

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

 

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

    Drug: Carboplatin
    Key eligibility:
    • Node positive or high-risk node negative (≥3 cm) triple-negative breast cancer
    • No synchronous or previous contralateral invasive breast cancer
    • No prior ipsilateral invasive or noninvasive breast cancer
    Trial design: double-blind, placebo controlled
    PI: Anne Schott, M.D.
    UMCC trial number: NRG-BR003.

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

 

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Phase III Study to Assess the Efficacy and Safety of Olaparib vs. Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2-Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

    Target: PARP
    Drug: olaparib
    Key eligibility:
    • BRCA1 or BRCA2 positive
    • Triple negative breast cancer or ER and/or PR+, HER2-
    • If received neoadjuvant chemotherapy, must have residual disease after a minimum of 6 cycles
    • If received adjuvant chemotherapy, must be node positive or high risk node negative (>2 cm) (if TNBC) or ≥4 nodes positive (if ER+)
    Trial design: double-blind, placebo controlled
    PI: Anne Schott, M.D.
    UMCC trial number: NSABP B-55.

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

 

Breast Cancer Weight Loss Study (BWEL Study)

    Key eligibility:
    • Must have confirmed breast cancer
    • Must be overweight-
    • Must not be participating in any other weight-loss program
    Trial design: randomized, Phase III
    PI: Anne Schott, M.D.
    UMCC trial number: A011401.

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


HER2-Positive Early Stage Disease

None at this time.


ER-Positive Early Stage Disease

Breast Cancer Weight Loss Study (BWEL Study)

    Key eligibility:
    • Must have confirmed breast cancer
    • Must be overweight-
    • Must not be participating in any other weight-loss program
    Trial design: randomized, Phase III
    PI: Anne Schott, M.D.
    UMCC trial number: A011401.

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

 

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2-Negative Breast Cancer

    Target: mTOR
    Drug: everolimus
    Key eligibility:
    • ER and/or PR positive, HER2 negative breast cancer
    • 4+ node positive, or 1-3 nodes positive and either OncotypeDX>25 or grade 3, or node negative with tumor size ≥2 cm AND Oncotype DX >25, or 1+ positive nodes following neoadjuvant chemotherapy
    Trial design: double-blind, placebo controlled
    PI: Anne Schott, M.D.
    UMCC trial number: SWOG S1207.

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

 

A prospective, single-arm cohort study of patients receiving endocrine therapy alone (without radiotherapy) after breast conserving surgery for early-stage, post-menopausal breast cancer patients whose tumors have favorable biologic features

    Key eligibility:
    • Must be between the ages of 50 to 69 years
    • Must be post-menopausal
    • No metastatic disease
    Trial design: Interventional, open-label
    PI: Reshma Jagsi, M.D., DPhil
    UMCC Trial number: UMCC 2014.111.

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


Trials for Symptom Management

Hypnosis vs. Relaxation for the Improvement of Self-Image Related to Sexual Health

    Drug: none (hypnosis vs. relaxation)
    Key eligibility:
    • Stage 0-IV, on or off breast cancer treatment
    • Not receiving 2 or more antidepressants
    Trial design: open label, 3 visits required
    PI: Debra Barton, R.N., Ph.D.
    Trial number: HUM000100709

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


Miscellaneous

None at this time.