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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
......
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Clinical study of first-line endocrine therapy for type ER+/PR+ and ER+/PR- advanced breast cancer

Excerpt:
Patients in the AI treatment group received anastrozole (1 mg), letrozole (2.5 mg), or exemestane (25 mg) once per day for 4 consecutive weeks (1 cycle). Patients in the fulvestrant treatment group received an intramuscular injection of fulvestrant (500 mg) on days 0, 14, 28, and every 28 days thereafter (1 cycle)....for both the whole cohort and the AI subgroup, the total survival of patients with ER+/PR+ breast cancer was longer than that of patients with ER+/PR− breast cancer, and the difference was statistically significant (P<0.001)....we found that PR status was an independent predictor of first-line endocrine therapy responses in hormone receptor-positive HER2 negative patients.
DOI:
10.21037/apm-20-2180