Breast Cancer

Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant versus Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)(D9722C00001)

MOA: Saruparib (AZD5305) is a selective inhibitor of PARP1, with minimal effect on PARP2. Camizestrant (AZD9833) is a next generation SERD with activity in both ESR1 mutant and WT settings.

Key Eligibility:

• Histologically or cytologically documented HR-positive (ER > 1%), HER2-negative (IHC 0/1+ or IHC 2+/ ISH-) based on local testing
• Locally advanced/metastatic breast cancer with no prior systemic therapy in the advanced/metastatic setting
• Participants must have BRCA1/2 or PALB2 loss of function mutation prior to screening, either germline (local testing) or somatic (central testing)
• Pre/peri-menopausal women and males must be on an LHRH agonist
• Measurable disease by RECIST 1.1
• Disease progression ≤84 days following (neo)adj tx for EBC excluded
• Disease progression ≤1 year from last dose of PARPi, platinum-agent, CDK4/6i, or oral SERD for EBC excluded

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant versus Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)(D9722C00001)

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were Previously Treated with T-DXd (ACE-Breast-03)

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node -positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)(STML-ELA-0422)

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK4/6 inhibitor Therapy (OPERA-01) 

A Phase 3, Randomized, Open-Label, Multicenter, Controlled Study To Evaluate The Efficacy And Safety Of Zanidatamab In Combination With Physician’s Choice Chemotherapy Compared To Trastuzumab In Combination With Physician’s Choice Chemotherapy For The Treatment Of Participants With Metastatic HER2-Positive Breast Cancer Who Have Progressed On, Or Are Intolerant To, Previous Trastuzumab Deruxtecan Treatment (EmpowHER-303)

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) with or without Durvalumab compared with Investigator's Choice of Chemotherapy (Paclitaxel/Nab-paclitaxel or Gemcitabine+ Carboplatin) in combination with Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

Open-label, Safety Extension Study for Subjects with Hormone-Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer (OVELIA) Study (TOL2506A-EXT)

Phase 2 Single Arm Trial with a Safety Lead-in of Tucatinib in Combination with Doxil for the Treatment of HER2+ Metastatic Breast Cancer (BRE 381)

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 in Patients with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer (AC699-001)

A PHASE III RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY

A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease (D8535C00001)

A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Trastuzumab-based Therapy (FLAMINGO-01)

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene Expression Profiles: An Adaptable Registry (FLEX Registry)