^
    3d
    Chidamide combined with fulvestrant in the treatment of HR-positive, HER2-negative advanced breast cancer after failure of previous endocrine therapy: a single-arm, single-center, phase 2 study. (PubMed, Breast Cancer Res)
    Chidamide combined with fulvestrant showed encouraging antitumor activity and tolerable toxicity in pts with HR + /HER2- advanced breast cancer that had progressed after previous endocrine therapy. Trial registration ChiCTR2100044282, registered on March 14th 2021.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    fulvestrant • Epidaza (chidamide)
    3d
    MRT-2359-001: Study of Oral MRT-2359 in Selected Cancer Patients (clinicaltrials.gov)
    P1/2, N=174, Active, not recruiting, Monte Rosa Therapeutics, Inc | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    HR positive • HER-2 negative • MYCN amplification
    |
    Xtandi (enzalutamide) • fulvestrant • MRT-2359
    3d
    Fulvestrant With or Without Ganetespib in HR+ Breast Cancer (clinicaltrials.gov)
    P2, N=50, Completed, Dana-Farber Cancer Institute | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR positive
    |
    fulvestrant • ganetespib (ADX-1612)
    4d
    GOG-3069: A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (clinicaltrials.gov)
    P2, N=51, Active, not recruiting, GOG Foundation | Recruiting --> Active, not recruiting | Trial completion date: Apr 2026 --> Nov 2028 | Trial primary completion date: Apr 2025 --> May 2028
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability)
    |
    PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    4d
    Targeting Semaphorin 7a signaling in preclinical models of endocrine therapy-resistant breast cancer. (PubMed, Mol Cancer Ther)
    Using mouse models of ER+BC (FVB/N mice, TC11 tumor model), we show reduced growth of SEMA7A+ tumors with PI3K inhibitors (GCT-007:10 mg/kg daily, alpelisib: 20mg/kg daily), alone or in combination with tamoxifen (0.5mg/100uL, every 3rd day). Combination of an anti-SEMA7A antibody (SmAbH1) (100-250 ug/100uL, every other day) and fulvestrant (83 mg/kg, every 5 days) also revealed that direct inhibition of SEMA7A via SmAbH1 significantly reduces tumor growth of SEMA7A-expressing tumors, and that the efficacy of SmAbH1 is not diminished by the standard of care, fulvestrant. Overall, our studies suggest that patients with ER+SEMA7A+ tumors should be candidates for PI3K-targeted therapies or anti-SEMA7A-based therapy.
    Preclinical • Journal
    |
    ER (Estrogen receptor) • SEMA7A (Semaphorin 7A)
    |
    ER positive
    |
    tamoxifen • Piqray (alpelisib) • fulvestrant
    6d
    Inavolisib-based Combination Therapy for the Treatment of PIK3CAMutated HR+/HER2- Breast Cancer: An Overview. (PubMed, Mini Rev Med Chem)
    Furthermore, it discusses the emerging resistance mechanisms to PI3K inhibition, mitigation of adverse effects, and future directions for inavolisib in personalized oncology. As studies continue to demonstrate its clinical utility, inavolisib exhibits preferential activity against the mutated PI3Kα isoform, thereby enhancing therapeutic specificity for combination therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    7d
    TBCRC 041: Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer (clinicaltrials.gov)
    P2, N=96, Completed, Mayo Clinic | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 amplification • HER-2 negative • HER-2 expression • ER negative • HER-2 negative + ER positive
    |
    fulvestrant • alisertib (MLN8237)
    7d
    FALCON: A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. (clinicaltrials.gov)
    P3, N=462, Completed, AstraZeneca | Trial completion date: Aug 2027 --> Jan 2026 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    |
    fulvestrant • anastrozole
    9d
    Real-World Utilization of Palbociclib as First-Line Treatment for Canadian HR+/HER2- Women with Metastatic Breast Cancer: Results from PALCAN Study. (PubMed, Curr Oncol)
    The median duration of treatment for patients receiving an AI as an accompanying therapy was 15.1 (13.6-17.4) months and 7.9 months (5.8-12.6) for patients receiving fulvestrant, which may suggest endocrine resistance in the latter group. The PALCAN data provides insights into practice patterns and the effectiveness of palbociclib as a first-line therapy in female patients with HR+/HER2- breast cancer in the Canadian real-world setting.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant
    10d
    AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=99, Completed, AstraZeneca | Active, not recruiting --> Completed
    Trial completion
    |
    fulvestrant • vistusertib (AZD2014)
    10d
    Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov)
    P2, N=47, Active, not recruiting, City of Hope Medical Center | Trial primary completion date: Mar 2026 --> Oct 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Ibrance (palbociclib) • fulvestrant • letrozole
    11d
    TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Mayo Clinic | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 negative • HER-2 expression
    |
    paclitaxel • fulvestrant • letrozole • Herzuma (trastuzumab-pkrb) • anastrozole • exemestane • Trazimera (trastuzumab-qyyp) • denifanstat (TVB-2640)