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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 2014.059/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 PI3K
    Drug:enzalutamide plus/minus taselisib
    Key eligibility:
    • Any number of prior therapies for metastatic breast cancer
    • AR ≥ 10% to be confirmed centrally
    • Measurable or evaluable, including bone only disease
    • No brain metastases
    Trial design: :Open label, randomized (3:1) with crossover permitted at progression
    PI: Catherine Van Poznak, M.D.
    UMCC trial number and sponsor: UMCC 2015.125/TBCRC #32, Translational Breast Cancer Research Consortium, Genentech, and Medivation/Astellas
    Learn more by reading the complete listing.

    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

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 UMHealthResearch.org.

    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 vs. Placebo When Administered to Metastatic HER2-negative Hormone Receptor Positive Breast Cancer Subjects with Bone Metastasis Treated with Hormonal Treatment Background Therapy

    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)
    • 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 2014.084/HUM00091381/Bayer

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


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/HUM00091381/Bayer

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


Brain Metastases

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


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.


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 3 prior chemotherapies in the metastatic setting
    • May have had prior platinum if platinum-sensitive
    Trial design: Randomized to single agent BMN673 vs. M.D. choice chemotherapy
    PI: Anne Schott, M.D.
    UMCC trial number and sponsor: UMCC2013.102/Medivation
    Learn more by reading the complete listing on UMHealthResearch.org.

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


Triple-Negative Early Stage Disease

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 and sponsor: NRG-BR003. View the complete listing on ClinicalTrials.org.

    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

HER2-Positive Early Stage Disease

A Randomized Phase II Study of Adjuvant Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination with Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT Trial)

    Drug: Ado-trastuzumab emtansine
    Key eligibility:
    • Node negative, <2 cm, stage 1, HER2-positive breast cancer
    • Can be ER positive or negative
    Trial design: Open label
    PI: Catherine Van Poznak, M.D.
    UMCC trial number and sponsor: UMCC2015-075/TBCRC #033
    Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.


ER-Positive Early Stage Disease

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 and sponsor: SWOG S1207. View S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer's complete listing.

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


A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)


Trials for Symptom Management

A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients with Chronic Pain

    Drug: duloxetine
    Key eligibility:
    • Average pain at least 4/10 that developed or worsened following breast cancer diagnosis (can be surgery, chemotherapy, or endocrine therapy related)
    • Stage 0-III breast cancer, diagnosed in the past 12 years
    Trial design: open label, 5 weeks, designed to evaluate efficacy as well as mechanism of action (2 clinic visits required)
    PI: Anne Schott, M.D.
    UMCC trial number and sponsor: UMCC 2013-044

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


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.
    UMCC trial number and sponsor: HUM000100709

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


Prospective study evaluating the use of PROSPECT, a cognitive behavioral therapy-based internet module, to reduce insomnia in patients with early stage breast cancer

    Drug: none
    Key eligibility:
    • Stage 0-III breast cancer, on or off breast cancer treatment
    • Insomnia for at least the past 30 days
    • No change in medications for insomnia for the past 4 weeks
    • Completed surgery, RT, and/or chemotherapy >6 weeks ago
    Trial design: internet-based open label intervention, one clinic visit required
    PI: Daniel Hayes, M.D..
    UMCC trial number and sponsor: HUM00108676, UMCC 2015.168. View Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer

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


Miscellaneous

Clinical and Biological Characterization of Male Breast Cancer: An International EORTC, BIG, TBCRC and NABCG Intergroup Study


 

View all available Breast Cancer Clinical Trials:

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

There are also quality of life clinical studies available.

If you have any questions, please contact Cancer AnswerLine™ at 800-865-1125.

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