TPS 89 A Randomized Phase 3 Study of First-Line Saruparib (AZD5305) Plus Camizestrant Versus CDK4/6i Plus Physician’s Choice Endocrine Therapy or CDK4/6i Plus Camizestrant in Patients With HR+/HER2– Advanced Breast Cancer With BRCA1/BRCA2/PALB2 Mutations (EvoPAR-B)

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 38-39

TPS 89 A Randomized Phase 3 Study of First-Line Saruparib (AZD5305) Plus Camizestrant Versus CDK4/6i Plus Physician’s Choice Endocrine Therapy or CDK4/6i Plus Camizestrant in Patients With HR+/HER2– Advanced Breast Cancer With BRCA1/BRCA2/PALB2 Mutations (EvoPAR-B)

TPS 89 A Randomized Phase 3 Study of First-Line Saruparib (AZD5305) Plus Camizestrant Versus CDK4/6i Plus Physician’s Choice Endocrine Therapy or CDK4/6i Plus Camizestrant in Patients With HR+/HER2– Advanced Breast Cancer With BRCA1/BRCA2/PALB2 Mutations (EvoPAR-B)

Background

Emerging evidence indicates that homologous recombination deficiency (HRD) contributes to resistance to CDK4/6 inhibitors (CDK4/6i) plus endocrine therapy (ET). Patients with germline or somatic mutations in BRCA1, BRCA2, and/or PALB2 genes (BRCA1 mutation/BRCA2 mutation/PALB2 mutation) and hormone receptor–positive/HER2-negative (HR+/HER2–) advanced breast cancer have poorer outcomes with first-line standard-of-care CDK4/6i plus ET than patients without these mutations. Clinical benefit with PARP inhibitors (PARPi) has been demonstrated in patients with HRD breast cancer, and PARPi are approved for the treatment of patients with germline BRCA1/BRCA2 mutations and HR+ /HER2– early or advanced breast cancer. Clinical trials have shown that PARPi use in early lines of therapy can result in a greater magnitude of benefit. PARPi use may also induce reversion mutations that restore homologous recombination proficiency, potentially sensitizing tumors to CDK4/6i. Saruparib (AZD5305) is a first-in-class highly selective PARP1 inhibitor that has increased potency and improved pharmacokinetic and pharmacodynamic properties compared with other approved PARPi. The phase 3 EvoPAR-Breast01 study (NCT06380751) is evaluating the efficacy and safety of saruparib plus camizestrant, a next-generation oral selective estrogen receptor degrader (SERD) and pure estrogen receptor antagonist, vs physician’s choice of CDK4/6i plus ET or CDK4/6i plus camizestrant in participants with germline/somatic BRCA1 mutation/BRCA2 mutation/PALB2 mutation HR+/HER2– advanced breast cancer.

Materials and Methods

EvoPAR-Breast01 is a randomized, open-label, 3-arm, multicenter, global study. Study design and eligibility criteria are shown in the Figure. Participants will be randomized 2:2:1 to receive saruparib plus camizestrant, physician’s choice CDK4/6i (abemaciclib, ribociclib, or palbociclib) plus physician’s choice ET (fulvestrant, letrozole, anastrozole, or exemestane), or physician’s choice CDK4/6i plus camizestrant, respectively. Treatment will continue until disease progression per RECIST v1.1, unacceptable toxicity, or participant-initiated withdrawal. The primary end point is progression-free survival (PFS) by blinded independent review committee in the saruparib plus camizestrant vs CDK4/6i plus ET arms. Overall survival (OS) is a secondary end point. Planned statistical analyses of PFS and OS will be conducted using a stratified log-rank test.

Status

Participant enrollment is ongoing across 185 trial locations in 20 countries. Approximately 500 participants will be randomized across the 3 arms.

Articles in this issue

39 Development and Validation of a Questionnaire to Assess Motivation and Satisfaction in Mastectomy Patients With or Without Reconstruction
39 Development and Validation of a Questionnaire to Assess Motivation and Satisfaction in Mastectomy Patients With or Without Reconstruction
40 Frequency of Documented IHC Score in Patients With HER2-Negative Breast Cancer in the US: An Observational Study Using Guardian Research Network Data
40 Frequency of Documented IHC Score in Patients With HER2-Negative Breast Cancer in the US: An Observational Study Using Guardian Research Network Data
41 Provider Preferences and Practices in Testing and Reporting HER2 Immunohistochemistry in Patients With Breast Cancer: A Survey and Interview Study Among US Pathologists and Oncologists
41 Provider Preferences and Practices in Testing and Reporting HER2 Immunohistochemistry in Patients With Breast Cancer: A Survey and Interview Study Among US Pathologists and Oncologists
42 Exploring the Treatment Gap in High-Risk HR+, HER2– Early Breast Cancer: Eligible Patients Not Receiving Abemaciclib in the US
42 Exploring the Treatment Gap in High-Risk HR+, HER2– Early Breast Cancer: Eligible Patients Not Receiving Abemaciclib in the US
TPS 43 ADELA: A Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial of Elacestrant + Everolimus vs Elacestrant + Placebo in ER+/HER2– Advanced Breast Cancer Patients With ESR1-Mutated Tumors Progressing on Endocrine Therapy
TPS 43 ADELA: A Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial of Elacestrant + Everolimus vs Elacestrant + Placebo in ER+/HER2– Advanced Breast Cancer Patients With ESR1-Mutated Tumors Progressing on Endocrine Therapy
45 A Phase 3 Randomized Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response at Surgery
45 A Phase 3 Randomized Study of Adjuvant Sacituzumab Tirumotecan Plus Pembrolizumab vs Treatment of Physician’s Choice in Patients With Triple-Negative Breast Cancer Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response at Surgery
46 Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for High-Risk, Early-Stage Triple-Negative Breast Cancer: Overall Survival and Subgroup Results From the Phase 3 KEYNOTE-522 Study
46 Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for High-Risk, Early-Stage Triple-Negative Breast Cancer: Overall Survival and Subgroup Results From the Phase 3 KEYNOTE-522 Study
48 Prevalence of “HER2 Ultra-Low” Among Advanced Breast Cancer Patients With Historical IHC0 Status
48 Prevalence of “HER2 Ultra-Low” Among Advanced Breast Cancer Patients With Historical IHC0 Status
49 Clinical Characteristics and Treatment Persistence in US Patients With HR+/HER2–, Node-Positive Early Breast Cancer Treated With Abemaciclib: Real-World Study From First Year After Approval
49 Clinical Characteristics and Treatment Persistence in US Patients With HR+/HER2–, Node-Positive Early Breast Cancer Treated With Abemaciclib: Real-World Study From First Year After Approval
52 Correlation and Prediction of Complete Pathologic Response Rates and Ki-67 in Patients Receiving Neoadjuvant Immunotherapy for Triple-Negative Breast Cancer
52 Correlation and Prediction of Complete Pathologic Response Rates and Ki-67 in Patients Receiving Neoadjuvant Immunotherapy for Triple-Negative Breast Cancer
53 Comparison of Surgical Complications With Direct-to-Implant vs Tissue Expander Reconstruction After Wise Pattern Skin-Sparing Mastectomy
53 Comparison of Surgical Complications With Direct-to-Implant vs Tissue Expander Reconstruction After Wise Pattern Skin-Sparing Mastectomy
54 The Treatment of Breast Cancer With Percutaneous Thermal Ablation: Results of the THERMAC Trial
54 The Treatment of Breast Cancer With Percutaneous Thermal Ablation: Results of the THERMAC Trial
55 Do Genetic Counseling and Testing Affect Rates of Contralateral Prophylactic Mastectomy in Patients Without Clinically Actionable Mutations?
55 Do Genetic Counseling and Testing Affect Rates of Contralateral Prophylactic Mastectomy in Patients Without Clinically Actionable Mutations?
56 Paternal vs Maternal Inheritance of a BRCA Mutation: Is There a Difference in Presentation and Stage of Breast Cancer at Diagnosis?
56 Paternal vs Maternal Inheritance of a BRCA Mutation: Is There a Difference in Presentation and Stage of Breast Cancer at Diagnosis?
57 Tumor Morphology Concordance in Multifocal/Multicentric Triple- Negative and HER2+ Breast Cancers
57 Tumor Morphology Concordance in Multifocal/Multicentric Triple- Negative and HER2+ Breast Cancers
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