OncoMatch/Clinical Trials/NCT06998108
Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy
Is NCT06998108 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BEBT-209 capsules and Fulvestrant for hr+/her2- locally advanced, metastatic breast cancer.
Treatment: BEBT-209 capsules · Fulvestrant — This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (≥10% of tumor cells showing positive staining for ER)
ER+ is defined as ≥10% of tumor cells showing positive staining for ER
Required: PR (PGR) overexpression (≥10% of tumor cells showing positive staining for PR)
PR+ is defined as ≥10% of tumor cells showing positive staining for PR
Required: HER2 (ERBB2) negative (IHC score of 0 or 1+, or FISH ratio of HER2/CEP17 < 2.0, or HER2 gene copy number < 4)
HER2- is defined as an immunohistochemistry(IHC) score of 0 or 1+, or a fluorescence in situ hybridization(FISH) ratio of HER2/CEP17 less than 2.0, or HER2 gene copy number less than 4
Disease stage
Metastatic disease required
Evidence of focal recurrence or metastasis, not suitable for curative surgery or radiotherapy, and without clinical indications necessitating chemotherapy.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy (aromatase inhibitor, selective estrogen receptor modulator, tamoxifen, toremifene) — adjuvant or metastatic
progression during or within 12 months after discontinuation of adjuvant endocrine therapy (with an aromatase inhibitor [aromatase inhibitor or selective estrogen receptor modulator such as tamoxifen, toremifene, etc.]); progression during or within 1 month after discontinuation of endocrine therapy for first recurrence or metastasis
Cannot have received: fulvestrant (fulvestrant)
Previous treatment with fulvestrant
Cannot have received: mTOR inhibitor (everolimus)
Previous treatment with everolimus
Cannot have received: CDK4/6 inhibitor
Previous treatment with...CDK4/6 inhibitors
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L (without use of growth factors within 14 days); platelets ≥100×10⁹/L (without corrective treatment within 7 days); hemoglobin ≥90 g/L (without corrective treatment within 7 days)
Kidney function
serum creatinine ≤1.5x ULN or estimated creatinine clearance ≥60 mL/min
Liver function
AST and ALT ≤2.5x ULN (≤5x ULN for patients with liver metastases); total serum bilirubin (TBIL) ≤2.5x ULN
Cardiac function
12-lead ECG: Fridericia-corrected QT interval (QTcF) < 470 msec (for females)
Adequate organ and marrow function, defined as follows: absolute neutrophil count (ANC) ≥1.5×10⁹/L (without use of growth factors within 14 days); platelets ≥100×10⁹/L (without corrective treatment within 7 days); hemoglobin ≥90 g/L (without corrective treatment within 7 days); serum creatinine ≤1.5 times the upper limit of normal (ULN) or estimated creatinine clearance ≥60 mL/min; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the ULN (≤5 times the ULN for patients with liver metastases); total serum bilirubin (TBIL) ≤2.5 times the ULN; 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 msec (for females).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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