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.
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients with HER2-Positive Advanced Solid Tumors
PI: Aki Morikawa, M.D., Ph.D.
UM trial number: UMCC 2022.037
A Phase 1b open-label, multicenter dose escalation and expansion study of MT-5111 in subjects with previously treated advanced HER2-positive solid tumors
PI: Aki Morikawa, M.D., Ph.D.
UM trial number: 2021.97
A011801, The COMPASSHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD) DISEASE (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and TUCATINIB
PI: Aki Morikawa, M.D., Ph.D.
UM trial number: 2021.060
EA1181 - (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
PI: Kathleen Kemmer, M.D.
UM trial number: UMCC 2020.115
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer
PI: Reshma Jagsi M.D., DPhil
UM trial number: UMCC 2018.133/SWOG S1706
S1501 Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III
PI: Erin Cobain, M.D.
UM trial number: UMCC 2017.153
A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
PI: Vaibhav Sahai, MBBS, MS
UMCC 2020.124
Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects with Advanced Refractory Solid Tumor Malignancies
PI: Ulka Vaishampayan, MBBS
UMCC 2021.023
Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors
PI: Rashmi Chugh, M.D.
UMCC 2021.016
A Phase 1 Dose-Escalation Trial of Talazoparib in combination with Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
PI: Monika Burness, M.D.
UMCC 2020.122
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
PI: Erin Cobain, M.D.
UM trial number: UMCC 2019.035
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
PI: Ajjai Alva, MBBS
UM trial number: UMCC 2016.004
Molecular Analysis for Therapy Choice (MATCH)
PI: Ajjai Alva, MBBS
UM trial number: UMCC 2015.124
A Dose-escalation Study of the Safety and Pharmacology of DAN 222 in Subjects with Metastatic Breast Cancer
PI: Aki Morikawa, M.D., Ph.D.
UMCC 2022.029
NRG-BR007: A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage 1, Hormone Sensitive, HER2-Negative, Oncotype Recurrent Score
PI: Reshma Jagsi, M.D., DPhil
UMCC 2021.080
S2007, A Phase III Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016 ) for Patients with HER2-Negative Breast Cancer and Brain Metastases
PI: Aki Morikawa, M.D., Ph.D.
UMCC 2021.032
Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
PI: Lynn Henry, M.D., Ph.D.
UM trial number: UMCC 2020.041
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer
PI: Reshma Jagsi M.D., DPhil
UM trial number: UMCC 2018.133/SWOG S1706
Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
PI: Reshma Jagsi M.D., DPhil
UM trial number: UMCC 2018.098
A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
PI: Vaibhav Sahai, MBBS, MS
UMCC 2020.124
Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects with Advanced Refractory Solid Tumor Malignancies
PI: Ulka Vaishampayan, MBBS
UMCC 2021.023
Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors
PI: Rashmi Chugh, M.D.
UMCC 2021.016
A Phase 1 Dose-Escalation Trial of Talazoparib in combination with Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
PI: Monika Burness, M.D.
UMCC 2020.122
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
PI: Erin Cobain, M.D.
UM trial number: UMCC 2019.035
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
PI: Ajjai Alva, MBBS
UM trial number: UMCC 2016.004
Molecular Analysis for Therapy Choice (MATCH)
PI: Ajjai Alva, MBBS
UM trial number: UMCC 2015.124
A Dose-escalation Study of the Safety and Pharmacology of DAN 222 in Subjects with Metastatic Breast Cancer
PI: Aki Morikawa, M.D., Ph.D.
UMCC 2022.029
A Randomized Phase 3 Double-blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants with Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer with Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)
PI: Monika Burness, M.D.
UMCC 2021.088
S2007, A Phase III Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016 ) for Patients with HER2-Negative Breast Cancer and Brain Metastases
PI: Aki Morikawa, M.D., Ph.D.
UMCC 2021.032
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer
PI: Reshma Jagsi M.D., DPhil
UM trial number: UMCC 2018.133/SWOG S1706
A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
PI: Vaibhav Sahai, MBBS, MS
UMCC 2020.124
Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects with Advanced Refractory Solid Tumor Malignancies
PI: Ulka Vaishampayan, MBBS
UMCC 2021.023
Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors
PI: Rashmi Chugh, M.D.
UMCC 2021.016
A Phase 1 Dose-Escalation Trial of Talazoparib in combination with Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
PI: Monika Burness, M.D.
UMCC 2020.122
A Multi-center, Open Label Phase 1/2 Study of CYT-0851, an Oral RAD51 Inhibitor, in Patients with Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors
PI: Monika Burness, M.D.
UM trial number: UMCC 2019.183
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
PI: Erin Cobain, M.D.
UM trial number: UMCC 2019.035
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
PI: Ajjai Alva, MBBS
UM trial number: UMCC 2016.004
Molecular Analysis for Therapy Choice (MATCH)
PI: Ajjai Alva, MBBS
UM trial number: UMCC 2015.124
Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.
A Randomized Trial of the SYNC APP
PI: Sung Choi M.D., Ph.D.
UM trial number: UMCC 2020.157
Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.
Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
PI: Stephanie Patterson, M.D.
UM trial number: UMCC 2017.114
Referring Physicians/Healthcare Providers: Call M-Line at 800-962-3555. Patients: Call Cancer AnswerLine™ at 800-865-1125.
updated 12.12.2022