HR+/HER2- Locally Advanced, Metastatic Breast CancerPhase 3NCT06998108
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
A Phase 3 study testing BEBT-209 capsules and Fulvestrant Injection in people with HR+/HER2- Locally Advanced, Metastatic Breast Cancer, run by BeBetter Med Inc at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HR+/HER2- Locally Advanced, Metastatic Breast Cancer
- What is being tested?
- BEBT-209 capsules and Fulvestrant Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2022to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older who are postmenopausal or premenopausal/perimenopausal, and meet one of the following criteria: previous bilateral oophorectomy, or age ≥60 years; or age <60 years with natural menopause (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), and estradiol (E2) and follicle-stimulating hormone (FSH) levels in the postmenopausal range; or premenopausal or perimenopausal women willing to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy during the study period.
- 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.
- Evidence of focal recurrence or metastasis, not suitable for curative surgery or radiotherapy, and without clinical indications necessitating chemotherapy.
- 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.
- Patients are allowed to have received no more than one line of chemotherapy during the recurrence or metastatic phase.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
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- 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).
- 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).
- 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.
- All acute toxicities from prior anti-tumor therapy must have resolved to grade 0-1 (according to national cancer institute(NCI) common terminology criteria for adverse events(CTCAE) version 5.0) or to the levels specified in the inclusion/exclusion criteria. Exceptions include alopecia and other toxicities deemed by the investigator to pose no safety risk to the patient.
- The patient has provided written informed consent and is willing and able to comply with the planned visits, study treatment schedule, laboratory tests, and other study procedures.
Who cannot join
- 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).
- 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.
- Previous treatment with fulvestrant, everolimus, or CDK4/6 inhibitors.
- 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).
- 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.
- 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.
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- 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.
- 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.
- Inability to swallow, intestinal obstruction, or other factors that may affect the intake and absorption of medication.
- Known coagulation abnormalities; or use of anticoagulant therapy prior to intramuscular injection of fulvestrant or LHRH agonist (goserelin).
- Known allergy to fulvestrant, LHRH agonist (goserelin), BEBT-209/placebo, or any of their excipients.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of abuse of psychoactive substances or drug addiction.
- Poorly controlled diabetes mellitus as judged by the investigator.
- Uncontrolled hypertension as judged by the investigator.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Fan Zhang, Master, +86-13574805563, fzhang@bebettermed.com
About this study
Official title: A Multicenter, Randomized, Controlled, Double-blind Phase III Clinical Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant for the Treatment of HR+/HER2- Locally Advanced or Metastatic Breast Cancer in Patients With Disease Progression After Prior Endocrine Therapy
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.
Read the detailed description
This study plans to enroll 330 eligible female patients with locally advanced or metastatic breast cancer. All eligible patients will be randomly assigned to the treatment group or the control group in a 2:1 ratio. The following two factors will be used for stratification: 1) visceral metastasis (yes or no); 2) menopausal status (postmenopausal; premenopausal or perimenopausal). The study consists of a screening period, a treatment period, and a follow-up period. It aims to evaluate the efficacy and safety 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 experienced disease progression after prior endocrine therapy.
- Being tested
- BEBT-209 capsules, BEBT-209 Placebo capluses, Fulvestrant Injection
- Keywords
- BEBT-209, Efficacy, Safety
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEBT-209 capsulesDrug
Also called BEBT-209
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 caplusesDrug
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 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BEBT-209+ Fulvestrant | Active comparator | 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). Receives: Drug: BEBT-209 capsules; Drug: Fulvestrant Injection |
| BEBT-209 Placebo + Fulvestrant | Placebo comparator | 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). Receives: Drug: BEBT-209 Placebo capluses; Drug: Fulvestrant Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS assessed by the Independent Imaging Review Committee
Progression free survival (PFS) assessed by the Independent Imaging Review Committee
Measured: Up to 56 weeks
Secondary outcomes (6)
PFS assessed by investigators
Progression free survival assessed by investigators
Measured: Up to 56 weeks
OS
Overall Survival
Measured: Up to 56 weeks
ORR
Overall Objective Response
Measured: Up to 56 weeks
CBR
Clinical Benefit Rate
Measured: Up to 56 weeks
DOR
Duration of Response
Measured: Up to 56 weeks
Occurrence of Adverse Events (AEs)
Occurrence of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V5.0).
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start9 Jun 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Locally Advanced, Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeBetter Med Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, Ph.D, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998108
- Sponsor's protocol ID
- GBMT-209-P04
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Double-blind Phase III Clinical Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant for the Treatment of HR+/HER2- Locally Advanced or Metastatic Breast Cancer in Patients With Disease Progression After Prior Endocrine Therapy
- ClinicalTrials.gov ID
- NCT06998108
- Acronym / sponsor ID
- GBMT-209-P04
- Keywords
- BEBT-209, Efficacy, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- BeBetter Med IncIndustry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study plans to enroll 330 eligible female patients with locally advanced or metastatic breast cancer. All eligible patients will be randomly assigned to the treatment group or the control group in a 2:1 ratio. The following two factors will be used for stratification: 1) visceral metastasis (yes or no); 2) menopausal status (postmenopausal; premenopausal or perimenopausal). The study consists of a screening period, a treatment period, and a follow-up period. It aims to evaluate the efficacy and safety 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 experienced disease progression after prior endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEBT-209+ Fulvestrant | Active comparator | Drug: BEBT-209 capsules, Drug: Fulvestrant InjectionBEBT-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 Placebo + Fulvestrant | Placebo comparator | Drug: BEBT-209 Placebo capluses, Drug: Fulvestrant InjectionPlacebo 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women aged 18 years or older who are postmenopausal or premenopausal/perimenopausal, and meet one of the following criteria: previous bilateral oophorectomy, or age ≥60 years; or age <60 years with natural menopause (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), and estradiol (E2) and follicle-stimulating hormone (FSH) levels in the postmenopausal range; or premenopausal or perimenopausal women willing to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy during the study period.
- 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.
- Evidence of focal recurrence or metastasis, not suitable for curative surgery or radiotherapy, and without clinical indications necessitating chemotherapy.
- 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.
- Patients are allowed to have received no more than one line of chemotherapy during the recurrence or metastatic phase.
Key exclusion criteria (16 listed)
- 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).
- 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.
- Previous treatment with fulvestrant, everolimus, or CDK4/6 inhibitors.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEBT-209 capsulesAlso: BEBT-209Oral, 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. | Drug | BEBT-209+ Fulvestrant |
| BEBT-209 Placebo caplusesOral, 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. | Drug | BEBT-209 Placebo + Fulvestrant |
| Fulvestrant Injection500 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. | Drug | BEBT-209 Placebo + Fulvestrant, BEBT-209+ Fulvestrant |
Primary outcome
PFS assessed by the Independent Imaging Review Committee
Time frame: Up to 56 weeks
Progression free survival (PFS) assessed by the Independent Imaging Review Committee
6 secondary outcomes
PFS assessed by investigators
Time frame: Up to 56 weeks
OS
Time frame: Up to 56 weeks
ORR
Time frame: Up to 56 weeks
CBR
Time frame: Up to 56 weeks
DOR
Time frame: Up to 56 weeks
Occurrence of Adverse Events (AEs)
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Binghe Xu, Ph.D principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BEBT-209 capsules and Fulvestrant Injection in people with HR+/HER2- Locally Advanced, Metastatic Breast Cancer, run by BeBetter Med Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kegang Jiang, Master (+86-18664786382, kjiang@bebettermed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS assessed by the Independent Imaging Review Committee (time frame: Up to 56 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.