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 on clinicalstudies.gov.

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 UMClinicalStudies.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 III Randomized, Double-Blind, Placebo-Controlled Study of LEE011 or Placebo in Combination with Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women with Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Target: CDK4/6 pathway
Drug: LEE011, inhibitor of CDK4/6
Key eligibility:
  • First line, measurable or non-measurable disease
  • Premenopausal, no LHRH-agonist therapy
  • Prior adjuvant estrogen therapy ok if > 12 months
  • No prior CDK 4/6 inhibitor
  • Inflammatory breast cancer excluded
Trial design: double-blind, placebo controlled
PI: Anne Schott, M.D.
UMCC trial number and sponsor: UMCC2014.129/HUM00095076/Novartis

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 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

Target: HER2
Drug: Neratinib, an oral small molecular weight tyrosine kinase inhibitor of HER2
Key eligibility:
  • Progressive brain metastases
Trial design:<.strong> Open label with 3 cohorts (pre-surgery, prior lapatinib and no prior lapatinib)
PI: Catherine Van Poznak, M.D.
UMCC trial number and sponsor: UMCC2012.034/TBCRC #22, Translational Breast Cancer Research Consortium and Puma Biotechnology
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.


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.


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.

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

A Randomised, 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 and sponsor: NSABP B-55.

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

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

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)

Target: aromatase
Drug: anastrozole
Key eligibility:
  • Postmenopausal, starting treatment with AI therapy for stage I-III breast cancer
  • Asian
Trial design: open label
PI: Lynn Henry, M.D., Ph.D.
UMCC trial number and sponsor: ECOG E1Z11

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


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: Lynn Henry, M.D., Ph.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: Lynn Henry, M.D., Ph.D.
UMCC trial number and sponsor: HUM00108676, UMCC 2015.168

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

Miscellaneous Trials

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

Drug: none
Key eligibility:
  • Male with newly diagnosed breast cancer
  • Stage I-IV
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: UMCC2015.017/TBCRC #29/EORTC 10085, Translational Breast Cancer Research Consortium
Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.


 

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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