Breast-Oncology Clinical Trials June 2021 Neoadjuvant PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status UCI 14-67: A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Pathologically proven invasive breast cancer HER-2 monoclonal antibody Mehta Ashley Chanthapadith Paclitaxel with Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Tumor size is clinically at least 1 cm in greatest diameter (palpable Open to Accrual VEGF monoclonal antibody Neoadjuvant Setting or by imaging) and/or with involved lymph node Adjuvant PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Patients must have undergone immediate reconstruction at the Alliance A221505: Phase III Randomized Trial of Hypofractionated Post Mastectomy fractionated external radiation Kuo Ashley Chanthapadith time of mastectomy or be planning to undergo reconstruction Open to Accrual Radiation with Breast Reconstruction therapy within 8 months after radiation A011801: The COMPASSHER2 Trials (Comprehensive Use of Pathologic Response Patients must have HER2+ breast cancer with residual disease Assessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Antibody drug conjugate + kinase Parajuli Ashley Chanthapadith after NACT Open to Accrual Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and inhibitor No prior treatment w/ TDM-1 Placebo Compared with T-DM1 and Tucatinib Post-menopausal female patients UCI 18-79: A Phase II Clinical Trial on Neo-Adjuvant Abemaciclib with Fulvestrant in Histologically confirmed ER+ Breast Cancer Patients with ER/PR + HER-2 Negative Breast Cancer who Developed Localized CKD Inhibitor + Neoadjuvant Patients must have localized recurrence while on adjuvant Parajuli Ashley Chanthapadith Open to Accrual Recurrence While on Adjuvant Endocrine Therapy with Molecular Evidence of Endocrine Therapy endocrine therapy Endocrine Resistance Patients must not have inflammatory breast cancer No prior treatment with any CDK 4/6 inhibitor and/or Fulvestrant Metastatic PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Locally advanced unresectable or metastatic ER+, HER2- breast UCI 20-60 A Phase Ia/Ib Study of LY3484356 Administered as Monotherapy and in cancer or endometrial cancer. Up to 3 lines of treatment in Parajuli Ashley Chanthapadith Combination with Abemaciclib to Patients with ER+, HER2- Locally Advanced or non-covalent oral SERD Open to Accrual advanced/metastatic setting and progression while on endocrine Metastatic Breast Cancer and Other Select Non-Breast Cancers therapy. Patients must have history of prior treatment with a taxane and resistance to antibody-mediated trastuzumab in any setting, separately or in combination. Prior UCI 19-66: Randomized, Double-Blind, Phase III Study of Tucatinib or Placebo in inhibition using tyrosine kinase pertuzumab therapy is allowed, but not required. Parajuli Ashley Chanthapadith Combination with Ado-Trastuzumab Emtansine (T-DM1) for Subjects with Unresectable Open to Accrual inhibitor and antibody-based No prior treatment with tucatinib, lapatinib, neratinib, afatinib, Locally-Advanced or Metastatic HER2+ Breast Cancer therapy trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent or T-DM1. Histologically confirmed adenocarcinoma of the breast with locally NRG-BR004: A Randomized, Double-Blind, Phase III Trial of recurrent, unresectable disease or metastatic disease including: de PD-L1 antibody + HER2 Parajuli Ashley Chanthapadith Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive novo metastatic disease without prior history of HER2-positive BC Suspended monoclonal antibody Metastatic Breast Cancer or locally recurrent or metastatic disease following prior therapy for early BC Contact Info: A. Chanthapadith x509-2925/A.Serwanska x456-8279/ O. Quines x456-6244/E. Matsuda x509-2710/ C. Colmenares x509-2172/K. Ghio x456-6285/M.Tharani x509-2643/K. Buttigieg x456-7429/J. Balangue x509-2948 Page 1 July 2021 Breast-Oncology Clinical Trials June 2021 Metastatic HR+/HER2- breast cancer with progression on an AI UCI 19-88: A Phase III Double-Blind Randomised Study Assessing the Efficacy and Safety of AKT inhibitor + selective estrogen No more than 1 line of chemotherapy or more than 2 lines of Coluzzi Ashley Chanthapadith Capivasertib + Fulvestrant versus Placebo + Fulvestrant as Treatment for Locally Advanced Open to Accrual down-regulator endocrine therapy in the metastatic setting (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growt No prior treatment with Fulvestrant or AKT/PI3K/mTOR inhibitors IgG1 monoclonal antbody binding UCI 17-79: Phase 1b/2 study of SGN-LIV1A in combination with pembrolizumab for first- to LIV-1 and linker in lysosomes Metastatic or locally-advanced triple-negative breast cancer Parajuli Ashley Chanthapadith line treatment of patients with unresectable locally advanced or metastatic triple- Open to Accrual releasing MMAE which prevents Have not previously received therapy for the treatment negative breast cancer cell division. Histologically confirmed metastatic disease to the brain from any solid tumor. If progression occurred for the following tx in the CDK inhibitor + PI3K inhibitor + Bota Mehir Tharani Alliance A071701: Genetic Testing in Guiding Treatment for Patients with Brain Metastases metastatic setting: for HER2-positive breast cancer received prior Open to Accrual NTRK/ROS1 inhibitor HER-2 directed therapy; for TNBC, at least one chemotherapy in metastatic setting HER2-, metastatic breast cancer ETCTN 10302: Phase II Trial of Radium-223 Dichloride in Combination with Paclitaxel in Bone-targeted alpha particle If HR+, disease should have progressed on at least one line of Parajuli Ashley Chanthapadith Open to Accrual Patients with Bone Metastatic Breast Cancer emitting radiopharmaceutical hormone therapy and a CDK 4/6 inhibitor in metastatic setting No prior therapy w/ radionuclides HR+/HER2- metastatic breast cancer No more than one chemotherapy line in metastatic setting ETCTN 10287: A Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination For patients enrolling on Phase 2 portion of the study: Parajuli Ashley Chanthapadith with Copanlisib (FAC) versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Pan-class I PI3K inhibitor - must have resistance to endocrine therapy in metastatic setting Suspended Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA) -no prior treatment w/ CDK 4/6 inhibitor, Fulvestrant, or PI3K inhibitor in metastatic setting -no brain metastasis Metastatic triple negative breast cancer ETCTN 10146: Randomized Phase II Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + IgG monoclonal antibody + IgG2 Must be PD-L1 negative and have not received any prior therapies Parajuli Ashley Chanthapadith Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + monoclonal antibody + synthetic for metastatic TNBC Open to Accrual Tremelimumab in Patients with Metastatic Triple Negative Breast Cancer neoantigen targeting vaccine Must be considered a candidate for first line carboplatin + gemcitabine Histologic or cytologic diagnosis of a malignant soild tumor Subjects enrolled in Part 2a (monotherapy, dose expansion) must have SCLC with tumors that express B7H3 above a UCI 18-43: A Phase 1 First in Human Study Evaluating Safety and Efficacy of ABBV-155 given threshold per central laboratory testing; Parajuli Ashley Chanthapadith Monotherapy and Combined with Docetaxel in Adult Patients with Relapsed and Refractory Antibody drug conjugate Subjects enrolled to Part 2b (combination Open to Accrual Solid Tumors therapy, dose expansion) must have either NSCLC or HR+/HER2- breast cancer with tumors that express B7H3 above a given threshold per central laboratory testing and must have failed CDK 4/6 therapy Solid Tumors/Basket Trials PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Patients must have a metastatic solid tumor with MAPK-pathway alterations (excluding BRAF V600x) and no avaialble SOC therapies UCI 20-179: A Phase I/IB First-in-Human Study of the SHP2 Inhibitor BBP-398 (Formerly Rezazadeh TBD SHP2 inhibitor Patients with tumors harboring known activating mutations in Pending Activation Known as IACS-15509) in Patients with Advanced Solid Tumors BRAF V600X or SHP2 will be excluded Patients must not have previously received a SHP2 inhibitor Contact Info: A. Chanthapadith x509-2925/A.Serwanska x456-8279/ O. Quines x456-6244/E. Matsuda x509-2710/ C. Colmenares x509-2172/K. Ghio x456-6285/M.Tharani x509-2643/K. Buttigieg x456-7429/J. Balangue x509-2948 Page 2 July 2021 Breast-Oncology Clinical Trials June 2021 Solid Tumors/Basket Trials Have a solid tumor, pancreatic cancer, NSCLC with any activating mutation(s) in the MAPK pathway, and have not previously received a MAPK inhibitor Have melanoma or NSCLC with a BRAF V600 mutation and have UCI 21-55: A Phase Ib/II, Open-Label, Multi-Center Study of ERAS-007 ERK Inhibitor in Ou Oliver Quines ERK inhibitor not previously received a BRAF inhibitor Pending Activation Patients with Advanced or Metastatic Solid Tumors Have NSCLC with a KRAS G12C alteration, and not previously received a KRAS G12C inhibitor For all cohorts, there must be no available standard systemic therapy available and no prior treatment with an ERK inhibitor Advanced solid tumors that have failed, are intolerant to, or are UCI