^
    12d
    A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Memorial Sloan Kettering Cancer Center | N=23 --> 6
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • PALB2 mutation • RAD51C mutation • RAD51D mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + BRCA mutation
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib)
    16d
    Adjuvant olaparib real world data for BRCA positive, HER2-negative high-risk early breast cancer patients in the United Kingdom. (PubMed, J Oncol Pharm Pract)
    Nineteen patients had dose reductions due to adverse effects and four patients discontinued treatment early.ConclusionAdjuvant olaparib was well tolerated in our real-world UK population study, with toxicity profiles similar to the OlympiA trial. Fatigue was significantly more prevalent in the real-world cohort.
    Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative • HER-2 negative + HR positive + BRCA mutation
    |
    Lynparza (olaparib)
    1m
    Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial (clinicaltrials.gov)
    P2, N=30, Recruiting, Massachusetts General Hospital | Trial completion date: Mar 2027 --> Apr 2028 | Trial primary completion date: Aug 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA1 mutation • HR positive • HER-2 negative • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    |
    Guardant360® CDx
    |
    Talzenna (talazoparib)
    2ms
    Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study) (clinicaltrials.gov)
    P=N/A, N=0, Withdrawn, M.D. Anderson Cancer Center | N=300 --> 0 | Trial completion date: Dec 2033 --> Apr 2026 | Initiation date: Aug 2026 --> Apr 2026 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2031 --> Apr 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial withdrawal • Trial primary completion date • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    2ms
    Denosumab is associated with longer real-world progression-free survival in BRCA1/2-mutated HR+ /HER2 - breast cancer patients with bone metastases receiving CDK4/6 inhibitors: A multicenter Italian study. (PubMed, Eur J Cancer)
    In this real-world cohort, denosumab use was associated with longer rwPFS in germline BRCA1/2-mutated HR+/HER2- mBC with bone metastases.
    Clinical • Journal • Real-world evidence • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • HER-2 mutation • BRCA wild-type • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    |
    Prolia (denosumab)
    3ms
    Molecular Surveillance In Early Breast Cancer Using The Tumor-Informed ctDNA Assay Myriad Genetics Precise MRD Test; A Prospective Observational Multicenter Study (The MRD Molecular Surveillance Study) (clinicaltrials.gov)
    P=N/A, N=300, Not yet recruiting, M.D. Anderson Cancer Center
    New trial • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    5ms
    A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer (clinicaltrials.gov)
    P2, N=23, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
    |
    HR positive • HER-2 negative • PALB2 mutation • RAD51C mutation • RAD51D mutation • HR positive + HER-2 negative • HER-2 negative + HR positive + BRCA mutation
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib)
    6ms
    Real-world effectiveness of PARP inhibitors after CDK4/6 inhibitor therapy in BRCA-mutated HR-positive/HER2-negative advanced breast cancer. (PubMed, NPJ Breast Cancer)
    This benefit was confirmed in a multivariable analysis, supporting PARPi as the preferred option in eligible patients. Our findings suggest that PARPi should be prioritized in the post-CDK4/6i treatment sequence for BRCA LP/PV carriers with HR+/HER2 aBC and highlight the critical role of germline BRCA testing.
    Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    6ms
    OptiTROP-Breast01: SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=254, Active, not recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Mar 2025 --> Jun 2027
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    HER-2 negative • HER-2 expression • HER-2 negative + HR positive + BRCA mutation
    |
    gemcitabine • capecitabine • eribulin mesylate • vinorelbine tartrate • Jiataile (sacituzumab tirumotecan)
    7ms
    Factors influencing Patient Preferences for BRCA Testing and Adjuvant Therapy in HER2-Negative Early Breast Cancer in the United States: Best-Worst Scaling and Discrete Choice Experiment. (PubMed, Patient)
    Individuals reported that a key benefit of BRCA testing was the insight it provided into their treatment options, allowing for more personalized care. However, OOPC was a barrier to testing. Their choice to receive adjuvant therapy was most influenced by OOPC, followed by the tolerability of the treatment and the ability to receive a targeted therapy.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
    |
    HR positive • HER-2 negative • HER-2 negative + HR positive + BRCA mutation
    8ms
    Case Report: Fluzoparib combined Exemestane in gBRCA2-mutated HR+/HER2- advanced breast cancer. (PubMed, Front Pharmacol)
    The patient achieved a remarkably prolonged progression-free survival (PFS) of 37 months on this combination therapy, representing the longest period of disease control in her metastatic course. Although eventual progression occurred (new axillary lymph node metastasis and suspected hepatic recurrence), this case demonstrates the exceptional efficacy and durable disease control achievable with Fluzoparib plus Exemestane in a pretreated patient with gBRCA2-mutated HR+/HER2-advanced breast cancer, highlighting a promising therapeutic approach for this molecularly defined population.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA2 (Breast cancer 2, early onset)
    |
    HR positive • HER-2 negative • HER-2 mutation • HER-2 negative + ER positive • HER-2 negative + HR positive + BRCA mutation
    |
    exemestane • AiRuiYi (fluzoparib)
    8ms
    Real-World Epidemiology, Clinical Characteristics and Outcomes of Women with Germline BRCA Mutation and Early Breast Cancer in China. (PubMed, Oncol Ther)
    Characteristics, treatment patterns and outcomes were distinct among patients in China with gBRCAm eBC. Our findings support wider implementation of gBRCA testing for all patients in China with HER2-negative eBC, beyond those with triple-negative tumour subtype and/or family history of cancer, to identify more patients who may benefit from targeted therapy. Infographic available for this article.
    Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    HR positive • HER-2 negative • BRCA mutation • HER-2 negative + HR positive + BRCA mutation
    |
    Lynparza (olaparib)