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    Association details:
    Biomarker:HR positive
    Cancer:Hormone Receptor Positive Breast Cancer
    Drug:fulvestrant (Selective estrogen receptor degrader)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    01/19/2021
    Excerpt:
    FASLODEX is an estrogen receptor antagonist indicated for the treatment of...HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet
    Title:

    Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

    Published date:
    12/17/2016
    Excerpt:
    Progression-free survival was significantly longer in the fulvestrant group than in the anastrozole group (hazard ratio [HR] 0·797, 95% CI 0·637-0·999, p=0·0486)....Fulvestrant has superior efficacy and is a preferred treatment option for patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not received previous endocrine therapy compared with a third-generation aromatase inhibitor, a standard of care for first-line treatment of these patients.
    DOI:
    10.1016/S0140-6736(16)32389-3
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients

    Excerpt:
    ...Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory....
    Trial ID:
    IMPORTANT
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients

    Excerpt:
    ...Diagnosis of hormone receptor positive (HR+), HER2 negative breast cancer....
    Trial ID:
    FUMANCE
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

    Excerpt:
    ...- Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection,...
    Trial ID:
    NCT05759546
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

    Excerpt:
    ......
    Trial ID:
    NCT04256941
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers

    Excerpt:
    ...Patient has pathologically confirmed hormone receptors (HR)-positive (ER+ and/or PgR+) and HER2-negative advanced BC by local laboratory on the last tissue examined....
    Trial ID:
    MATRIX
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    VS-6766+Abema+Fulv in Met HR+/HER- BC

    Excerpt:
    ...- Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer....
    Trial ID:
    NCT05608252
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.

    Excerpt:
    ...- Participants with HR-positive HER2-negative locally advanced or metastatic breast cancer....
    Trial ID:
    NCT05905341
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer

    Excerpt:
    ...To evaluate the bone scan response rate in patients with hormone-receptor-positive breast cancer with bone metastases receiving cabozantinib. ...
    Trial ID:
    NCT01441947
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Advanced Breast Cancer Study of CDK4/6 Inhibitor Combined With Endocrine Therapy Endocrine Therapy in HR+/HER2- Advanced Breast Cancer

    Excerpt:
    ...2) For breast cancer patients diagnosed as HR-positive and HER2-negative by pathological examination, the expression levels of ER, PR, and HER2 were reported by immunohistochemistry in the primary or metastatic lesions....
    Trial ID:
    NCT05295043
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer

    Excerpt:
    ...- hormone receptor positive (ER and/or PgR) disease as determined locally...
    Trial ID:
    NCT00816582
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

    Excerpt:
    ...- Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer...
    Trial ID:
    NCT02088684
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

    Excerpt:
    ...To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant...
    Trial ID:
    NCT00146601
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    The value of circulating tumor DNA monitoring in the management of the endocrine therapy of fluvistam in estrogen receptor positive breast cancer patients

    Excerpt:
    ...HR positive patients were detected by IHC, HER2 was not amplified; 6. ...
    Trial ID:
    ChiCTR2000033307
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A Multicenter, Randomized, Controlled, Double-Blind Phase III Study of BEBT-209 in Combination with Fulvestrant Versus Placebo in Combination with Fulvestrant in HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy

    Excerpt:
    ...Histologically confirmed HR-positive, HER2-negative breast cancer patients (receiving the test results of tissue samples from recurrent/metastatic lesions or tissue samples from previous primary lesions, based on the latest test results): a) ER-positive and/or PR-positive defined as: ER/PR-positive staining of tumor cells in ≥ 10% of all tumor cells; b) HER2-negative defined as: standard immunohistochemistry (IHC) test results of 0 or 1+; FISH HER2/CEP17 ratio less than 2.0 or HER2 gene copy number less than 4; 3. ...
    Trial ID:
    ChiCTR2200059623
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A Multicenter, Randomized, Controlled, Double-Blind Phase III Study of BEBT-209 in Combination with Fulvestrant Versus Placebo in Combination with Fulvestrant in HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy

    Excerpt:
    ......
    Trial ID:
    ChiCTR2200059458
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Phase Ib/II clinical trial of BEBT-908 combined with BEBT-209 in patients with advanced recurrent or metastatic HR+/HER2- breast cancer

    Excerpt:
    ...Patients with advanced recurrent or metastatic breast cancer diagnosed by histology, immunohistochemical detection of HR positive staining cells >= 10% and HER2 negative (receive the latest metastatic tissue sample or previous primary tumor tissue sample test results), menopausal state or receiving LHRH agonist treatment, there is evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy for the purpose of cure; those who meet any of the following can be considered to have reached the menopausal state: (1) Premenopausal/perimenopausal female patients agree to use concomitant luteinizing hormone-releasing hormone (LHRH agonist), and start receiving LHRH agonist treatment at least 28±2 days before the first dose of study dosing can be considered to meet the inclusion criteria3 (Those who have used LHRH agonist for >=21 days but = 60 years; aged = 12 months, follicle-stimulating hormone (FSH) and estradiol (E2) levels in the postmenopausal range without chemotherapy, tamoxifen, toremifene, or ovarian castration within the past year (judged based on the reference range of each research center); (3) For patients aged = 1500/mm^3 (1.5 x 10^9/L); (2) Platelets >= 100000/mm^3 (100 x 10^9/L); (3) Hemoglobin >= 9g/dL (90g/L); (4) Both ALT or AST are l bilirubin (TBIL) =60mL/min (according to Cockcroft and Gault formula); Note: No blood components, hematopoietic-stimulating factors (including granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, erythropoietin, and thrombopoietin, etc.) are allowed within the first 14 days of screening laboratory tests. ...
    Trial ID:
    ChiCTR2100054270
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

    Excerpt:
    ...Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)`Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501`Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 in participants with solid tumors`Part 1: RDFE of BG-68501 and fulvestrant in participants with hormone-receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer`Part 2: Objective Response Rate...
    Trial ID:
    BG-68501-101