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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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HER-2 Positive

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

A Phase 1b open-label, multicenter dose escalation and expansion study of MT-5111 in subjects with previously treated advanced HER2-positive solid tumors

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

EA1181 - (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

S1501 Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III

A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

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

Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors

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

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Molecular Analysis for Therapy Choice (MATCH)

Hormone Receptor Positive

A Dose-escalation Study of the Safety and Pharmacology of DAN 222 in Subjects with Metastatic Breast Cancer

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

S2007, A Phase III Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016 ) for Patients with HER2-Negative Breast Cancer and Brain Metastases

Phase 2 Trial of Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

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

Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors

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

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Molecular Analysis for Therapy Choice (MATCH)

Triple Negative

A Dose-escalation Study of the Safety and Pharmacology of DAN 222 in Subjects with Metastatic Breast Cancer

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)

S2007, A Phase III Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016 ) for Patients with HER2-Negative Breast Cancer and Brain Metastases

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

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

Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors

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

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

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Molecular Analysis for Therapy Choice (MATCH)

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

Symptom management

A Randomized Trial of the SYNC APP

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

Mammography

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.

 

updated 12.12.2022