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Advanced Breast CancerPhase 1NCT06047184

Phase I Study of BEBT-209 in Women With Advanced Breast Cancer

A Phase 1 study testing BEBT-209 capsules, Letrozole tablets and Fulvestrant in people with Advanced Breast Cancer, run by BeBetter Med Inc at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This clinical study includes a dose escalation trial of BEBT-209 monotherapy in HR +/HER2- advanced breast cancer patients and a Phase 1b trial of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant in ER +/HER2- advanced breast cancer in women. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
BEBT-209 capsules, Letrozole tablets and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesChina
Study dates
15 Jul 2019to 30 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age: ≥18 years old;
  • Confirmed HR +/HER2- breast cancer in women with evidence of focal recurrence or metastasis not amenable to curative surgical resection or radiation therapy.
  • Menstrual status:
  • 3.1 Subjects enrolled in the dose escalation phase, Phase Ib combined with letrozole, combined with fulvestrant first-line therapy were required to be female patients who achieved menopausal status or were treated with LHRH agonists; 3.2 Subjects enrolled in Phase Ib monotherapy and combined fulvestrant second-line/third-line therapy are required to be postmenopausal, premenopausal/ perimenopausal, and amenorrheic women;
  • Menopausal status(note 2) is defined as having met any of the following:
  • Prior bilateral oophorectomy;
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  • Age≥ 60 years old
  • Age < 60 years, Spontaneous amenorrhea ≥ 12 months and blood follicle-stimulating hormone (FSH) and estradiol (E2) levels within the postmenopausal range (in conjunction with reference ranges at each site) in the absence of chemotherapy, tamoxifen, toremifene, or ovarian castration within the past year;
  • Patients < 60 years of age who were taking tamoxifen or toremifene had blood follicle-stimulating hormone (FSH) and estradiol (E2) levels within the postmenopausal range on two consecutive occasions (in conjunction with reference ranges at each site);
  • Not meeting the above criteria for menopause is considered premenopausal or perimenopausal; Note 2:Premenopausal/perimenopausal female patients agree to use concomitant luteinizing hormone-releasing hormone (LHRH agonist) and start treatment with LHRH agonist at least 28 ± 2 days before the start of the first dose of study drug can be considered to meet inclusion criteria 3.1 (if LHRH agonist has been used for ≥ 21 days but < 26 days before the first dose, hormone levels are eligible can be considered to meet inclusion criteria 3.1) ;
  • Prior Therapy( Note 3):
  • 4.1 Patients who have failed standard therapy or for whom standard therapy is not applicable are required for the dose escalation phase; 4.2 Phase IB monotherapy group: patients who have previously failed antiestrogen therapy and received at least 1 chemotherapy regimen; 4.3 The stage IB combined letrozole group required no previous first-line treatment for focal recurrent or metastatic ER + breast cancer; 4.4 Prior therapy in the Stage IB combined fulvestrant arm must have met one of the following: 4.4.1 Premenopausal/perimenopausal/postmenopausal patients can be enrolled, and premenopausal/perimenopausal patients are required to use luteinizing hormone-releasing hormone (LHRH agonist) at the same time; 4.4.2 Progression confirmed by imaging during or within 12 months after discontinuation of adjuvant endocrine therapy (AI or TAM); 4.4.3 Progression confirmed by imaging during or within one month after discontinuation of endocrine therapy for the first recurrence and metastasis; 4.4.4 Patients in the relapse or metastatic stage are allowed to receive no more than one line of chemotherapy in addition to endocrine therapy.
  • Note 3: The number of lines of therapy and corresponding menstrual status definitions refer to the Ribociclib Phase 3 Clinical Study (NCT02422615), the abemaciclib Phase 2 Clinical Study (Clin Cancer Res. 2017 September 01; 23 (17): 5218 - 5224), and the Palbociclib in Combination with Fulvestrant Clinical Study (NCT02738866).
  • Measurable lesions as defined by RECIST V.1.1 or osteolytic bone metastases only as judged by the investigator based on clinical presentation. Tumor lesions previously treated with radiotherapy or other local therapy were considered measurable only if disease progression at the treatment site was clearly documented after completion of treatment.
  • ECOG score of 0-2.
  • Have adequate organ and bone marrow function, defined as follows: ANC≥1,500/mm^3（1.5 x 10^9 /L）； Platelet ≥ 100,000/mm^3 (100 x10
  • ^9 /L）； hemoglobin≥ 9 g/dL (90 g/L); Both ALT or AST ≤ 2.5×ULN, and ALT or AST ≤ 5.0×ULN in liver metastasis; Total bilirubin (TBIL) ≤ 1.5×ULN, 3.0×≤ULN in liver metastasis; Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min (according to the Cockcroft and Gault formula).
  • Resolution of all acute toxicities from prior anticancer therapy or surgical procedures to baseline severity or NCICTCAE version 5.0 ≤ Grade 1 (except alopecia or other toxicities that, in the opinion of the investigator, pose no safety risk to the patient).
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to starting study drug and be willing to use a medically recognized highly effective form of birth control (eg, intrauterine device, contraceptive pill, or condom) during the study and for 1 month after the last dose of study drug.
  • Willing to sign the informed consent form after thorough understanding.

Who cannot join

  • combined with any other malignancy (except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ).
  • symptomatic, advanced patients who have disseminated to the viscera and are at risk of life-threatening complications in the short term (patients with visceral crisis); inflammatory breast cancer.
  • Known or symptomatic active CNS metastases characterized by clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth.
  • Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 4 weeks prior to the first dose.
  • Patients who have received the following treatments within 7 days prior to study entry: drugs known to be potent inhibitors/inducers of CYP3A4; drugs known to significantly prolong the QT interval.
  • previous treatment with CDK4/6 inhibitors.
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  • Patients previously treated with fulvestrant and everolimus cannot be enrolled in cohorts 4 and 5.
  • QTc interval > 480 msec (based on the average of three screening electrocardiograms [ECGs]); a history or confirmed family history of long QT syndrome; a history of clinically significant ventricular arrhythmias, or current use of antiarrhythmic drugs or a defibrillator device implanted to treat ventricular arrhythmias.
  • Uncontrolled electrolyte disturbances that may affect the effects of QTc prolonging drugs.
  • previous myocardial infarction, severe/unstable angina pectoris, NCICTCAE version 5.0 grade ≥ 2 sustained arrhythmia, atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism);
  • active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastrectomy; known malabsorption syndrome or other conditions that may impair absorption of BEBT-209.
  • Known history of hypersensitivity or suspected symptoms of hypersensitivity to any component of letrozole, fulvestrant, BEBT-209 capsules.
  • Clinically significant active infections including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) -related diseases. Active hepatitis B was defined as having positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) and HBV DNA ≥ 2000 IU/ml (equivalent to 104 copies/ml); active hepatitis C was defined as having HCV RNA above the lower limit of detection.
  • Other serious acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk of study participation or increase the risk associated with study drug administration, or interfere with study results, as well as other conditions that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.
  • Recent active suicidal ideation or behavior.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410013

Other trials in China

About this study

Official title: A Phase I, Open, Multicenter Study of BEBT-209 in Women With Advanced Breast Cancer

This clinical study includes a dose escalation trial of BEBT-209 monotherapy in HR +/HER2- advanced breast cancer patients and a Phase 1b trial of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant in ER +/HER2- advanced breast cancer in women. To evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant. To determine the recommended dose for late clinical studies of monotherapy or combination therapy in patients with HR +/HER2- advanced breast cancer.

Read the detailed description
  • Dose escalation phase: To conduct approximately 6 dose levels, with a starting dose of 25 mg/day of BEBT-209, and subsequent dose groups were first dose escalated at 100%, with dose escalation at 50% for subsequent dose groups if one drug-related Grade 2 nonhematologic or Grade 3 hematologic toxicity was identified and dose-limiting toxicity was not reached. If one dose limiting toxicity was identified and the maximum tolerated dose was not reached, dose escalation was performed at 33% for the subsequent dose groups.
  • Phase Ib of BEBT-209 as single therapy, in Combination with Letrozole, in Combination with Fulvestrant: According to the pharmacokinetics, safety and preliminary efficacy of BEBT-209 in the dose escalation phase, one dose was selected for the BEBT-209 monotherapy group, two doses were selected for the combination with letrozole group, and two doses were selected for the combination with fulvestrant group, and all five groups were continuously administered until disease progression or unacceptable toxicity or patient withdrawal or death. Late phase clinical trials were conducted as appropriate based on preliminary safety tolerability, pharmacokinetics, and preliminary efficacy results from Phase 1b.

Participants will need to understand the requirements and risks of the trial, sign an informed consent form, accept the dosing regimen required by the trial protocol, and follow the investigator's guidance.

Being tested
BEBT-209 capsules, Letrozole tablets, Fulvestrant
Keywords
BEBT-209, Safety, Tolerability, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEBT-209 capsulesDrug

    Also called KCBT-0191

    BEBT-209 capsules, 25mg once daily, or 25mg, 50mg, 75mg, 100mg, 150mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.

  • Letrozole tabletsDrug

    Also called Femara

    Letrozole tablets, 2.5mg each time, once a day for 4 weeks, 4 weeks as a treatment cycle.

  • FulvestrantDrug

    Also called FASLODEX

    Fulvestrant, injection, 500mg each time, 1 time on day 1 and day 15 of the first cycle, and once on the first day of each cycle from the second cycle, 4 weeks as a treatment cycle

Study groups in NCT06047184
Study groupRoleWhat they receive
Monotherapy group 1ExperimentalBEBT-209 capsules, 25mg once daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.
Receives: Drug: BEBT-209 capsules
Monotherapy group 2ExperimentalBEBT-209 capsules, 25mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.
Receives: Drug: BEBT-209 capsules
Monotherapy group 3ExperimentalBEBT-209 capsules, 50mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.
Receives: Drug: BEBT-209 capsules
Monotherapy group 4ExperimentalBEBT-209 capsules, 75mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.
Receives: Drug: BEBT-209 capsules
Monotherapy group 5ExperimentalBEBT-209 capsules, 100mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.
Receives: Drug: BEBT-209 capsules
Monotherapy group 6ExperimentalBEBT-209 capsules, 150mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle.
Receives: Drug: BEBT-209 capsules
BEBT-209 combined with the letrozole group 1ExperimentalBEBT-209 capsules, 100mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle. Letrozole tablets, 2.5mg each time, once a day for 4 weeks, 4 weeks as a treatment cycle.
Receives: Drug: BEBT-209 capsules; Drug: Letrozole tablets
BEBT-209 combined with the letrozole group 2ExperimentalBEBT-209 capsules, 75mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle. Letrozole tablets, 2.5mg each time, once a day for 4 weeks, 4 weeks as a treatment cycle.
Receives: Drug: BEBT-209 capsules; Drug: Letrozole tablets
BEBT-209 combined with the Fulvestrant Group 1ExperimentalBEBT-209 capsules, 75mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle. Fulvestrant, injection, 500mg each time, 1 time on day 1 and day 15 of the first cycle, and once on the first day of each cycle from the second cycle, 4 weeks as a treatment cycle
Receives: Drug: BEBT-209 capsules; Drug: Fulvestrant
BEBT-209 combined with the Fulvestrant Group 2ExperimentalBEBT-209 capsules, 100mg each time, twice daily, were administered continuously for 3 weeks and discontinued for 1 week, and 4 weeks were used as a treatment cycle. Fulvestrant, injection, 500mg each time, 1 time on day 1 and day 15 of the first cycle, and once on the first day of each cycle from the second cycle, 4 weeks as a treatment cycle
Receives: Drug: BEBT-209 capsules; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD

    Maximum tolerated dose

    Measured: 4 weeks

  2. DLT

    Dose-limiting toxicity

    Measured: 4 weeks

Secondary outcomes (11)

  1. ORR

    Objective response rate

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  2. CBR

    clinical benefit rate

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  3. PFS

    progression-free survival

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  4. DOR

    Duration of response

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  5. Cmax

    Peak Plasma Concentration

    Measured: Day 1 and Day 21 of cycle 1 before and within 48 hours after administration (each cycle is 28 days)

  6. Tmax

    Time of peak Plasma Concentration

    Measured: Day 1 and Day 21 of cycle 1 before and within 48 hours after administration (each cycle is 28 days)

  7. t1/2

    Half-life of plasma drug concentrations

    Measured: Day 1 and Day 21 of cycle 1 before and within 48 hours after administration (each cycle is 28 days)

  8. AUC0-48h

    Area under the blood concentration time curve from 0 to 48 hours after administration

    Measured: Day 1 and Day 21 of cycle 1 before and within 48 hours after administration (each cycle is 28 days)

  9. AUC0-last

    Area under the blood concentration time curve from time zero to the last dose

    Measured: Day 1 and Day 21 of cycle 1 before and within 48 hours after administration (each cycle is 28 days)

  10. CL/F

    Apparent total plasma clearance

    Measured: Day 1 and Day 21 of cycle 1 before and within 48 hours after administration (each cycle is 28 days)

  11. Vd

    Apparent volume of distribution

    Measured: Day 1 and Day 21 of cycle 1 before and within 48 hours after administration (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start15 Jul 2019
  3. Primary completion30 Jan 2024
  4. Study completion30 Jan 2024

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Dose escalation phase: 6 dose levels are carried out, the starting dose of BEBT-209 is set to 25mg/day, and the accelerated titration method combined with the "3+3" mode is used for climbing research. Phase Ib: According to the pharmacokinetics, safety and preliminary efficacy of BEBT-209 in the dose escalation phase, one dose was selected for the BEBT-209 monotherapy group, two doses were selected for the combination with letrozole group, and two doses were selected for the combination with fulvestrant group, and all five groups were continuously administered until disease progression or unacceptable toxicity or patient withdrawal or death.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047184
Sponsor's protocol ID
GBMT-209-P01
Status last verified
Aug 2026
First submitted
7 Sep 2023
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BEBT-209 capsules, Letrozole tablets and Fulvestrant in people with Advanced Breast Cancer, run by BeBetter Med Inc at 2 sites 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 20 inclusion and 15 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: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047184.

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 18 Aug 2026.

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