Breast

HER2-Positive

CIRB #H-42687/ CTSU #A011801 (CompassHER2-RD): CompassHER2 Residual Disease – A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared With T-DM1 and Tucatinib 

Hormone Receptor-Positive & HER2-Negative

CIRB #H-45164/ NRG BR007 DEBRA: A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (pending IRB)

Central IRB #pend/ AstraZeneca #AZD9833-D8536C0001 (SERENA-8): A Randomised, Multicentre, Open-Label, Phase III study of Camizestrant + Capivasertib Versus Physician’s Choice of Endocrine-Based Therapy in Patients with Estrogen Receptor-Positive, HER2-Negative Inoperable Locally Advanced or Metastatic Breast Cancer Whose Disease has Progressed on Treatment with an Aromatase Inhibitor + CDK4/6 inhibitor (pending sponsor)

Triple Negative

CIRB #H-44585/ SWOG #S2212 (SCARLET): Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study

CIRB #H-44586/ CTSU #A012103 (OptimICE-pCR): De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

CIRB #H-43958/ ETCTN 10525: A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative Breast Cancer (pending)

CIRB #H-42956/ ETCTN #10449: A Phase 1 Study of ZEN003694 in Combination with Binimetinib in Solid Tumors with RAS Pathway Alterations and Triple Negative Breast Cancer (temporary closure)

Imaging

IRB #H-33188/ BMC #DOSI: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)

IRB #H-37386/ CTSU #EA1151 (TMIST): Tomosynthesis Mammographic Imaging Screening Trial