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
NCT ID: NCT06998108
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
330 participants
INTERVENTIONAL
2022-06-09
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase I Study of BEBT-209 in Women With Advanced Breast Cancer
NCT06047184
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
NCT05433480
GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer
NCT05054751
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
NCT06635447
Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
NCT04263298
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BEBT-209+ Fulvestrant
BEBT-209 75 mg twice daily on days 1-21 in combination with fulvestrant 500 mg once daily (day 1 and day 15 of cycle 1; subsequent cycles: day 1).
BEBT-209 capsules
Oral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
Fulvestrant Injection
500 mg intramuscular injection, with a 28-day treatment cycle. Administration on day 1 and day 15 of the first cycle, and then on day 1 of each subsequent cycle.
BEBT-209 Placebo + Fulvestrant
Placebo 75 mg twice daily on days 1-21 in combination with fulvestrant 500 mg once daily (day 1 and day 15 of cycle 1; subsequent cycles: day 1).
BEBT-209 Placebo capluses
Oral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
Fulvestrant Injection
500 mg intramuscular injection, with a 28-day treatment cycle. Administration on day 1 and day 15 of the first cycle, and then on day 1 of each subsequent cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BEBT-209 capsules
Oral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
BEBT-209 Placebo capluses
Oral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
Fulvestrant Injection
500 mg intramuscular injection, with a 28-day treatment cycle. Administration on day 1 and day 15 of the first cycle, and then on day 1 of each subsequent cycle.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with histologically confirmed HR+/HER2- breast cancer (based on the most recent test results from either recurrent/metastatic lesion tissue samples or prior primary lesion tissue samples): a) ER+ and/or PR+ is defined as ≥10% of tumor cells showing positive staining for ER/PR; b) 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.
3. Evidence of focal recurrence or metastasis, not suitable for curative surgery or radiotherapy, and without clinical indications necessitating chemotherapy.
4. Previous endocrine therapy must meet one of the following criteria: a) 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.); b) progression during or within 1 month after discontinuation of endocrine therapy for first recurrence or metastasis.
5. Patients are allowed to have received no more than one line of chemotherapy during the recurrence or metastatic phase.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
7. Presence of measurable lesions according to response evaluation criteria in solid tumors (RECIST) 1.1 criteria or bone metastases only (including lytic or mixed lesions).
8. 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).
9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and must be willing to use a medically accepted and highly effective method of contraception from the time of signing the informed consent form, throughout the study period, and for 1 year after the last administration of the study drug.
Exclusion Criteria
1. Patients who are deemed by the investigator to be unsuitable for endocrine therapy, including those with symptomatic, visceral metastatic disease, or those at risk of life-threatening complications in the short term (including patients with uncontrollable effusions \[pleural, pericardial, peritoneal\] despite drainage or other measures, pulmonary lymphangitis, or more than 50% liver involvement).
2. Known uncontrolled or symptomatic active central nervous system (CNS) metastases, characterized by clinical symptoms, brain edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth; patients with a history of CNS metastases or spinal cord compression may be eligible if they have received definitive treatment and have been clinically stable for 4 weeks after discontinuation of anticonvulsants and corticosteroids prior to the first dose of study drug.
3. Previous treatment with fulvestrant, everolimus, or CDK4/6 inhibitors.
4. From the end of the last treatment to the first dose: underwent surgical or radiation therapy within 14 days prior to the first dose and has not fully recovered from the treatment; received chemotherapy, any investigational drug, or other anti-cancer therapy within 14 days or within five half-lives of the therapeutic agent prior to the first dose (whichever is longer is acceptable for enrollment).
5. A diagnosis of any other malignancy within 3 years prior to randomization, with the exception of non-melanoma skin cancer (basal cell or squamous cell carcinoma) or cervical carcinoma in situ that has been treated with curative intent.
6. Infection with human immunodeficiency virus (HIV) or known acquired immune deficiency syndrome (AIDS); active hepatitis B (patients positive for hepatitis B surface antigen \[HBsAg\] and with hepatitis B virus DNA \[HBV-DNA\] levels above the ULN of the local laboratory). Patients with HBV DNA levels above the ULN of the local laboratory are permitted to receive antiviral therapy prior to screening, and may be enrolled once viral copies are reduced below the ULN, but must continue antiviral therapy for hepatitis B during the study; hepatitis C (positive for hepatitis C virus antibody and with HCV RNA levels above the ULN of the local laboratory); or co-infection with both hepatitis B and hepatitis C.
7. Within 6 months prior to randomization, the following conditions have occurred: myocardial infarction, severe/unstable angina, heart failure of NYHA Class II or higher, persistent arrhythmia of Grade ≥2 (according to NCI CTCAE Version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism.
8. Severe infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungal, or antiviral therapy according to clinical practice guidelines), or unexplained fever \>38.5℃ during the screening period or prior to the first dose.
9. Inability to swallow, intestinal obstruction, or other factors that may affect the intake and absorption of medication.
10. Known coagulation abnormalities; or use of anticoagulant therapy prior to intramuscular injection of fulvestrant or LHRH agonist (goserelin).
11. Known allergy to fulvestrant, LHRH agonist (goserelin), BEBT-209/placebo, or any of their excipients.
12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
13. Known history of abuse of psychoactive substances or drug addiction.
14. Poorly controlled diabetes mellitus as judged by the investigator.
15. Uncontrolled hypertension as judged by the investigator.
16. Presence of other severe physical or psychiatric conditions or laboratory abnormalities that may increase the risk of participation in the study, interfere with the study results, or render the patient unsuitable for participation in the study as judged by the investigator.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chinese Academy of Medical Sciences
OTHER
BeBetter Med Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Binghe Xu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GBMT-209-P04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.