FASLODEX is an estrogen receptor antagonist indicated for the treatment of:...Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.

...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 <26 days before the first administration, if the hormone level meets the conditions, it can be considered to meet the inclusion criteria 3); (2) Receiving bilateral oophorectomy in the past; aged >= 60 years; aged < 60 years, natural menopause >= 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 <60 years who are taking tamoxifen or toremifene, the levels of serum follicle-stimulating hormone (FSH) and estradiol (E2) are within the postmenopausal range for two consecutive times (judged based on the reference range of each research center). ...

...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....

...- Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer...

...Diagnosis of hormone receptor positive (HR+), HER2 negative breast cancer....

...Histologically confirmed HR-positive, HER2-negative breast cancer patients (accept the test results of tissue samples of recurrent/metastatic lesions or previous primary lesions, the latest test results shall prevail): (1) ER-positive and/or PR-positive is defined as: ER/PR positively stained tumor cells account for >= 10% of all tumor cells; (2) HER2 negative is defined as: standard immunohistochemistry (IHC) test results are 0 or 1+; FISH test HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4; 3. ...

...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. ...

...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....

...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....

...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...

...- 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,...

...- Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer....

...- Participants with HR-positive HER2-negative locally advanced or metastatic breast cancer....

All pts completed surgery, with a tpCR rate 8.3% (3/36; 95% CI, 1.8%-22.5%). 29 (80.6%; 95% CI, 64.0%-91.8%) pts had pathological tumor response...The addition of fulvestrant to NCT showed manageable toxicity and promising antitumor activity for pts with HR+/HER2- locally advanced breast cancer.

At the final analysis of FALCON, no significant difference in OS was seen between fulvestrant and anastrozole in ET-naïve postmenopausal women with HR+/HER2– locally advanced or metastatic BC. The positive trend observed in OS for fulvestrant in non-visceral disease compared with visceral disease is consistent with the primary analysis.

147 HR+/HER2- MBC patients receiving fulvestrant 500mg were included…45(30.6%) were administered at first-line, 102(69.4%) were at second-line or later. PFS for the first-line was significantly longer than that for the second-line or later (15.9months vs. 6.1months, P= 0.000, HR = 0.448, 95% CI = 0.287-0.700)....Fulvestrant 500 mg administered was shown to be highly effective...