^
    12h
    A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Hoffmann-La Roche | N=44 --> 80 | Trial completion date: Dec 2030 --> Feb 2030
    Enrollment change • Trial completion date • Trial initiation date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation
    |
    Kisqali (ribociclib) • fulvestrant • Itovebi (inavolisib)
    3d
    Interaction of estrogen and interleukin 6 in the progression of lymphangioleiomyomatosis. (PubMed, Biochim Biophys Acta Mol Cell Res)
    Fulvestrant treatment had no significant inhibitory effect on IL-6 protein expression, whereas Stattic intervention inhibited ERα expression. The combined use of fulvestrant and Stattic significantly suppressed the proliferation and migration of TSC2-deficient cells, indicating that the IL-6/signal transducer and activator of transcription 3 (STAT3) pathway plays an important role in E2-promoted LAM progression and may serve as a potential therapeutic target for LAM.
    Journal
    |
    ER (Estrogen receptor) • IL6 (Interleukin 6) • TSC2 (TSC complex subunit 2)
    |
    fulvestrant
    4d
    A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    fulvestrant • letrozole
    4d
    Fulvestrant Enhances Temozolomide Effectiveness Against Glioblastoma: Insights from a Preclinical Study. (PubMed, Curr Neuropharmacol)
    These findings suggest that fulvestrant may be a promising chemosensitizing agent for glioblastoma treated with temozolomide.
    Preclinical • Journal
    |
    ER (Estrogen receptor) • MGMT (6-O-methylguanine-DNA methyltransferase) • HIF1A (Hypoxia inducible factor 1, alpha subunit)
    |
    temozolomide • fulvestrant
    4d
    Second-line therapies after CDK4/6 inhibitor failure in HR-positive/HER2-negative metastatic breast cancer patients: real-world data from the HERMIONE-13 study. (PubMed, ESMO Real World Data Digit Oncol)
    The most common regimens included capecitabine and everolimus plus exemestane. Multivariable analysis showed that younger age, prior fulvestrant use, and shorter CDK4/6i duration were associated with CHT choice...Treatment decisions are influenced by clinical history and patient characteristics. These findings underscore the need for personalized approaches and molecular profiling to guide post-CDK4/6i therapy in HR-positive/HER2-negative MBC.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
    |
    everolimus • capecitabine • fulvestrant • exemestane
    5d
    Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=256, Active, not recruiting, Laekna Limited | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    HER-2 negative • PIK3CA mutation • HER-2 expression • PTEN mutation • ESR1 mutation
    |
    fulvestrant • afuresertib (LAE002)
    5d
    ReDiscover-2: Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=540, Recruiting, Relay Therapeutics, Inc.
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    fulvestrant • Truqap (capivasertib) • zovegalisib (RLY-2608)
    5d
    Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Jan 2027 | Trial primary completion date: Mar 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    5d
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    carboplatin • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Piqray (alpelisib) • Irene (pyrotinib) • albumin-bound paclitaxel • abiraterone acetate • fulvestrant • Aidixi (disitamab vedotin) • exemestane • Padcev (enfortumab vedotin-ejfv) • bicalutamide • Kaitanni (cadonilimab) • goserelin acetate • Qibeian (iparomlimab/tuvonralimab) • Yidafan (ivonescimab) • iparomlimab (QL1604) • leuprolide acetate for depot suspension • Entyvio (vedolizumab)
    5d
    C4551001: Study of PF-07248144 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=320, Recruiting, Pfizer | Phase classification: P1 --> P2 | Trial primary completion date: Feb 2028 --> Jul 2029
    Phase classification • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • fulvestrant • letrozole • vepdegestrant (ARV-471) • atirmociclib (PF-07220060) • prifetrastat (PF-07248144)
    5d
    Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial. (PubMed, Breast Cancer Res Treat)
    This prospective real-world analysis shows slightly shorter median PFS and OS times compared with the pivotal trials. Patients in our analyses received alpelisib in later therapy lines, which may explain the poorer outcome.
    Journal
    |
    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 positive • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive • HR positive + HER-2 negative
    |
    Piqray (alpelisib) • fulvestrant
    6d
    INX-315-01: Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Incyclix Bio | Trial completion date: Jun 2026 --> Sep 2027 | Trial primary completion date: Dec 2025 --> Jul 2027
    Trial completion date • Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Verzenio (abemaciclib) • fulvestrant • INX-315