^
    4d
    Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (clinicaltrials.gov)
    P1/2, N=95, Recruiting, Ellipses Pharma | N=60 --> 95 | Trial completion date: Nov 2026 --> Feb 2028 | Trial primary completion date: Nov 2025 --> Feb 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    everolimus • Verzenio (abemaciclib) • fulvestrant • exemestane • Orserdu (elacestrant) • vosilasarm (EP0062)
    5d
    Bireociclib Plus Fulvestrant in Advanced Breast Cancer After Endocrine Progression: The BRIGHT-2 Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol)
    The final analysis of the BRIGHT-2 randomized clinical trial confirms improved PFS with the addition of bireociclib to fulvestrant, with manageable safety as a treatment option for patients with HR-positive, ERBB2-negative ABC with progression after prior endocrine therapy. ClinicalTrials.gov Identifier: NCT05077449.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • EGFR positive
    |
    fulvestrant • Xuan Yue Ning (bireociclib)
    5d
    Patient-derived xenograft models of primary breast cancer for preclinical evaluation of neoadjuvant therapies. (PubMed, Sci Transl Med)
    For triple-negative IBC, we demonstrated that neoadjuvant treatment does not benefit from addition of a PARP inhibitor, whereas for estrogen receptor-positive IBC, the combination of a CDK4/6 inhibitor and fulvestrant improved neoadjuvant treatment response. Our work provides a valuable resource of primary IBC models to study breast cancer biology and develop neoadjuvant treatments.
    Preclinical • Journal
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    fulvestrant • Undisclosed CDK4/6 inhibitor
    7d
    Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=138, Not yet recruiting, Shanghai Henlius Biotech
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant
    7d
    CONFIRM: Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. (clinicaltrials.gov)
    P3, N=736, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    ER (Estrogen receptor)
    |
    fulvestrant
    8d
    The impact of fulvestrant on estrogen receptor-driven chromatin dynamics in breast cancer cells. (PubMed, Epigenetics Chromatin)
    This study provides new insights into the mechanistic impact of FULV on ER activity, highlighting its ability to modulate H3K27ac dynamics even in the absence of transcriptional changes. These findings underscore the complexity of ER signaling and further suggest that FULV's therapeutic effects may extend beyond simple antagonism of ER activity.
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    tamoxifen • fulvestrant
    9d
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
    P1/2, N=40, Active, not recruiting, Criterium, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Aug 2024 --> Mar 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
    |
    HER-2 positive • PIK3CA mutation
    |
    Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
    |
    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    9d
    Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer (clinicaltrials.gov)
    P2, N=28, Completed, Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2026 --> Mar 2026 | Trial primary completion date: Aug 2026 --> Mar 2026 | Active, not recruiting --> Completed
    Trial completion • Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive
    |
    Verzenio (abemaciclib) • fulvestrant
    9d
    optINAVO: To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Hoffmann-La Roche
    Trial initiation date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    fulvestrant • Itovebi (inavolisib)
    11d
    OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=510, Recruiting, Olema Pharmaceuticals, Inc. | N=370 --> 510
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ESR1 mutation
    |
    fulvestrant • letrozole • anastrozole • exemestane • palazestrant (OP-1250)
    13d
    Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, University of California, Irvine | Active, not recruiting --> Recruiting | Trial completion date: Dec 2028 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    PGR (Progesterone receptor)
    |
    Verzenio (abemaciclib) • fulvestrant • anastrozole
    14d
    TBCRC 035: randomized phase II pharmacodynamic study of standard and reduced-dose palbociclib with endocrine therapy in hormone receptor (HR)-positive previously treated metastatic breast cancer. (PubMed, ESMO Open)
    Palbociclib 100 mg was associated with a reduced incidence of ≥grade 3 neutropenia. While PFS was numerically lower at 100 mg, the difference was not statistically significant and was limited by sample size and complicated by varying degrees of pre-treatment. Analysis of skin and tumor pRb or Ki-67 demonstrated robust molecular response at both doses. PIK3CA and TP53 mutations and higher baseline Ki-67 were associated with inferior clinical outcome.
    P2 data • PK/PD data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    TP53 mutation • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive
    |
    Ibrance (palbociclib) • tamoxifen • fulvestrant