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

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

Phase 1B Study to Assess the Safety, Tolerability and Clinical Activity of Gedatolisib in Combination with Palbociclib and either Letrozole or Fulvestrant in Women with Metastatic or Locally Advanced/Recurrent Breast Cancer (MBC)

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

A phase 1, open-label, dose-escalation study of SEA-CD40 in adult patients with advanced malignancies

A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects with Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study Exploring the safety, Tolerability, and Efficacy of INCAG1949 in combination with Immune Therapies in Subjects With Advanced or Metastatic Malignancies

A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy

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

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

A phase 1, open-label, dose-escalation study of SEA-CD40 in adult patients with advanced malignancies

A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects with Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study Exploring the safety, Tolerability, and Efficacy of INCAG1949 in combination with Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Phase 1B Study to Assess the Safety, Tolerability and Clinical Activity of Gedatolisib in Combination with Palbociclib and either Letrozole or Fulvestrant in Women with Metastatic or Locally Advanced/Recurrent Breast Cancer (MBC)

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic Her-2+ Breast Cancer, Phase III

A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy

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

A phase 1, open-label, dose-escalation study of SEA-CD40 in adult patients with advanced malignancies

A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects with Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study Exploring the safety, Tolerability, and Efficacy of INCAG1949 in combination with Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Phase 1B Study to Assess the Safety, Tolerability and Clinical Activity of Gedatolisib in Combination with Palbociclib and either Letrozole or Fulvestrant in Women with Metastatic or Locally Advanced/Recurrent Breast Cancer (MBC)

A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy

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

HER2 Negative, ER Negative

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

Brain Metastases

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

A phase 1, open-label, dose-escalation study of SEA-CD40 in adult patients with advanced malignancies

A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects with Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study Exploring the safety, Tolerability, and Efficacy of INCAG1949 in combination with Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Phase 1B Study to Assess the Safety, Tolerability and Clinical Activity of Gedatolisib in Combination with Palbociclib and either Letrozole or Fulvestrant in Women with Metastatic or Locally Advanced/Recurrent Breast Cancer (MBC)

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)

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study

A phase 1, open-label, dose-escalation study of SEA-CD40 in adult patients with advanced malignancies

A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors

A Single-Arm, Open-Label, Multicenter, Extended Treatment, Safety Study in Patients Treated With Talazoparib

Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589)

Phase II study of combination ruxolitinib (INCB018424) with preoperative chemotherapy for triple negative inflammatory breast cancer

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects with Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study Exploring the safety, Tolerability, and Efficacy of INCAG1949 in combination with Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Phase 1B Study to Assess the Safety, Tolerability and Clinical Activity of Gedatolisib in Combination with Palbociclib and either Letrozole or Fulvestrant in Women with Metastatic or Locally Advanced/Recurrent Breast Cancer (MBC)

A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy

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

Triple-Negative Invasive 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

Phase 1B Study to Assess the Safety, Tolerability and Clinical Activity of Gedatolisib in Combination with Palbociclib and either Letrozole or Fulvestrant in Women with Metastatic or Locally Advanced/Recurrent Breast Cancer (MBC)

Phase II study of combination ruxolitinib (INCB018424) with preoperative chemotherapy for triple negative inflammatory breast cancer

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects with Locally Advanced or Metastatic Solid Tumors

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

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

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

Breast Cancer Weight Loss Study (BWEL Study)

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

ER-Positive Early Stage Disease

Breast Cancer Weight Loss Study (BWEL Study)

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone

A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy

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

Patients taking oral chemotherapy

The validation of a novel adherence method for oral oncolytics

    PI: Shawna Kraft, Pharm.D.
    UM trial number: UMCC 2015.030

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

Mammography / Dense Breasts

Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

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

 

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