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 Treatment Using Weekly Carboplatin + Pathologically proven invasive HER-2 monoclonal antibody Mehta Ashley Chanthapadith Paclitaxel with + (HER2+) or (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 + 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

Post-menopausal female patients UCI 18-79: A Phase II Clinical Trial on Neo-Adjuvant with 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 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- (T-DM1) for Subjects with Unresectable Open to Accrual inhibitor and antibody-based No prior treatment with tucatinib, , , , Locally-Advanced or Metastatic HER2+ Breast Cancer therapy (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 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 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 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 () + 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 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 21-12: A Phase I/IB, Open-Label, Multicenter, Dose-Escalation Study of RMC-5552 considered ineligible for SOC anticancer treatments Ou Colin Pichon mTOR inhibitor Open to Accrual Monotherapy in Adult Subjects with Relapsed/Refractory Solid Tumors No prior mTOR and/or PI3K inhibitors

UCI 20-211: A Phase I, Open-Label, Multi-Center, Dose Escalation and Dose Expansion Histological or cytological diagnosis of ALK-positive advanced Study to Evaluate the Safety Tolerability, Pharmacokinetics, and Preliminary Evidence Small molecule inhibitor of SHP2 NSCLC, CRC with BRAF V600E mutation, or RAS- mutant, NF1- Ou Keagan Buttigieg Open to Accrual of Anti-Tumor Activity of PF-07284892 (Arry-558) as a Single Agent and in Combination + kinase inhibitor mutant or BRAF class 3-mutant solid tumor Therapy in Participants with Advanced Solid Tumors Must have had at least 1 prior line of therapy Stage III or IV locally advanced or metastatic NSCLC, breast cancer, UCI 20-128: A Phase III Randomized Placebo-Controlled Double-Blind Study of or ovarian cancer, or any stage recurrent disease Romiplostim for the Treatment of Chemotherapy-Induced Thrombocytopenia in Thrombopoietin (TPO) receptor Must be receiving cancer treatment with carboplatinum-based Pakbaz Emiri Matsuda Pending Activation Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer agonist combination chemotherapy regimens (NSCLC), Ovarian Cancer, or Breast Cancer Must have a platelet count < 75 x 109/L on day 1 of the study No prior use of any TPO agonist

HER2 expressing cancers, including breast, gastroesophageal, colorectal, endometrial, biliary tract, NSCLC, head and neck squamous cell carcinoma, and urothelial cohorts UCI 20-185: A Phase I/IB, Open-Label, Dose Escalation and Expansion Study of SBT6050 Anti-HER2 monoclonal antibody For HER2+ breast cancer, ≥2 prior lines required and must have Ou Oliver Quines Alone and in Combination with Pembrolizumab in Subjects with Advanced Solid conjugated to TLR8 agonist + received taxane, trastuzumab, pertuzumab, trastuzumab Pending Activation Tumors Expressing HER2 monoclonal IgG4 antibody emtansine, and tucatinib in the early stage or advanced setting For HER2 low expressing breast cancer, must have received either CDK4/6 inhibitor with endocrine therapy or taxane in the metastatic setting

Patients willing to undergo a leukapheresis procedure Patients with histologically or cytologically documented incurable UCI 19-38: A Phase IA/IB, Open-Label First-in-Human Study of the Safety, Tolerability, and metatstatic ER+/Her2(-) breast cancer Feasibility of Gene-Edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Autologous adoptive T-cell Patients who have ≥2 endocrine therapies for treatment of Bota Celine Colmenares Open to Accrual Single Agent or in Combination with Anti-PD-1 to Patients with Locally Advanced or therapy + Anti-PD-1 advanced/MBC (one of which was in combination with a CDK 4/6 Metastatic Solid Tumors inhibitor) Patients who have recieved ≥1 chemotherapy regimen for the treatment of advanced/MBC

Bota Mehir Tharani ECOG EAY131: Molecular Analysis for Therapy Choice (MATCH) Mutation based treatment Positive for Specific Mutations Open to Accrual

UCI 18-21: A Phase I/II Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, RET Patient with RET fusion-positive solid tumor or an advanced solid Ou Anabel Serwanska Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors inhibitor that harbors RET tumor that harbors a RET gene alteration (excluding synonymous, Open to Accrual with RET Activation (LIBRETTO-001) alterations frameshift, or nonsense mutation)

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 3 July 2021 Breast-Oncology Clinical Trials June 2021

Solid Tumors/Basket Trials Locally advanced or metastatic solid tumors w/ HER2 expression by UCI 20-67: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Immunotherapy agent targeting immunohistochemistry and/or erbb2 amplification and/or erbb2 Valerin Kristian Ghio Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Open to Accrual NK cells. activating mutations must be documented on either archival tissue Clinical Activity of DF1001 in Patients with Locally Advanced or Metastatic Solid Tumors or fresh tumor biopsy.

UCI 20-133: Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients Advanced solid tumors w/ RET gene abnormalities and has failed all Zhu Oliver Quines Selective RET Inhibitor Pending Activation with Advanced Solid Tumors with RET Gene Abnormalities available therapeutic options

Patients with triple negative breast cancer who have progressed, UCI-20-213: Phase I First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like JTX-8064 Monotherapy with anti- must have progressed on or after prior PD-(L)1 therapy. Jasmine Balangue Pending Activation Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy PD-1 (immunotherapy) No prior infusion of JTX-8064, LILRB2, or Immunoglobulin-like and in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Transcript 4 (ILT4)-directed therapy Dayyani Adult Subjects with Advanced Refractory Solid Tumor Malignancies Non-Treatment Trials (Diagnostic/Screening/Basic Science) PI CRC Protocol #/Title Mechanism Primary In/Ex Criteria Status Patients with Stage I-III solid tumors, except CNS tumors UCI 21-33: Electroacupuncture for the Management of Complex Symptoms in Cancer Patients with metastasis, psychiatric or mental disorders, needle Chan TBD Electroacupuncture Pending Activation Patients and Survivors: A Feasibility Study phobia, bleeding disorders, or have already received acupuncture treatment in the past 3 months will be excluded. UCI 20-205: Evaluating the Use of Patient-Reported Outcomes Measurement Chan TBD Information System (PROMIS) Tool to Monitor Symptom Burden in Cancer Patients PROMIS Tool Newly diagnosed cancer patients receiving anti-cancer treatment Pending Activation Receiving Chemotherapy Education UCI 16-23: Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Patients must be between the ages of 40 to 74 years old. Patients Anton-Culver Andrea Alvarez Annual Screening for Breast Cancer [The WISDOM study (Women Informed to Screen Risk based screening strategy must agree to receive breast screening at an Athena site (UCSF, Open to Accrual Depending on Measures of Risk)] UCSD, UCLA, UCI, or Stanford).

UCI 13-19: Registry Study of Patients Treated with Neoadjuvant Chemotherapy Kuo Bianca Del Veccio Data Collection Patients treated with chemotherapy followed by Mastectomy Open to Accrual Followed by Mastectomy in Stage I, II, III Breast Cancer

UCI 18-103: Blood Sample Collection to Evaluate Biomarkers in Subjects with Uchio Nyles Oune Blood Collection Patient has an untreated primary malignancy of breast Open to Accrual Untreated Solid Tumors

Patient with Stage I, Stage II, Stage III and Stage IV Breast cancer UCI 18-136: Blood Collection Protocol for the Analysis of Exosomes in Patients with Parajuli Ashley Chanthapadith Blood Collection Hormone Receptor +, Her-2 receptor positive, triple positive or Pending Activation Breast Cancer triple negative breast cancer

UCI 19-25: Baseline Assessment of Cancer Health Disparities in Underserved Patients must be at least 18 years of age and diagnosed with Bristow TBD N/A Pending Activation Populations in California breast cancer Patients must be female, at least 21 years of age or older, with UCI 17-43: Blood Collection Protocol for Circulating Tumor Cells and Circulating Cancer Parajuli Ashley Chanthapadith Blood Collection histolocially confirmed breast cancer and be diagnosed as Stage III Open to Accrual Associated Fibroblasts in Breast Cancer Patients or IV. Must not have other active cancers. Patients must be female, Vietnamese or Vietnamese American, at least 21 years of age or older, and in the early phases of their Tanjasiri TBD UCI 19-101: Cancer Navigation for Vietnamese Americans (CANVAS) Data Collection Pending Activation breast cancer experiences (ideally before or immediately after surgery) of invasive breast cancer stages I-III Positive SARS CoV-2 test within the 14 days Currently undergoing treatment for cancer (including NCICOVID: NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural Data Collection; Blood and O'Brien Carmen Lam chemotherapy, immunotherapy, monoclonal antibody therapy, Open to Accrual History Study Imaging target therapy, endocrine therapy, radiation therapy) or has received a transplant as cancer treatment

S1904: Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Standard Educational Materials Patients must have atypical hyperplasia (AH) or lobular carcinoma Increase Chemoprevention Informed Choice Among Women with Atypical Hyperplasia about Breast Cancer Lin Ashley Chanthapadith in situ (LCIS) with no history of invasive breast carcinoma or ductal Open to Accrual or Lobular Carcinoma In Situ- Making Informed Choices on Incorporating Risk/Chemoprevention + Web carcinoma in situ (DCIS) Chemoprevention into Care (MiCHOICE) Based Decision Support Tools No prior selective modulators or usage

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 4 July 2021