Health TrialsbyHealthPanel

A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer

ConditionAdvanced Triple-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBeBetter Med Inc

About this trial

This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 years old, female;

The subject has fully understood and is willing to sign the Informed Consent Form (ICF);

Confirmed diagnosis of HR-negative, HER2-negative locally recurrent or metastatic breast cancer by pathological biopsy;

Estrogen and progesterone receptor immunohistochemical assessment of tumor tissue is negative (defined as <1% nuclear staining), and HER2 is negative (i.e., no overexpression, including local immunohistochemical assessment [0 or 1+], or immunohistochemical assessment [2+] with negative in situ hybridization testing);

Disqualifiers

Previous treatment with gemcitabine;

Previous treatment with carboplatin for locally recurrent unresectable or metastatic breast cancer is allowed if it was administered in the adjuvant or neoadjuvant setting more than 6 months before the first metastatic relapse;

Concurrent central nervous system metastases or leptomeningeal disease requiring immediate radiotherapy or corticosteroid treatment; patients must discontinue steroid medication for at least 14 days before the first administration of the study drug. No stereotactic radiosurgery within 7 days or whole brain radiotherapy within 14 days before the first administration of the study drug;

Previous receipt of hematopoietic stem cell or bone marrow transplantation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BEBT-209 capsules

    Drug

    BEBT-209 Capsules, dosage: 150mg, frequency and duration of administration: administered on days 1, 2, 8, and 9 of each cycle, with a 21-day cycle. On days 1 and 8, take orally once before dinner or twice (before breakfast and before dinner), and on days 2 and 9, take orally once before breakfast.

  • Carboplatin injection

    Drug

    Carboplatin injection, dosage: AUC 2 × (creatinine clearance rate + 25), frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.

  • Gemcitabine hydrochloride for injection

    Drug

    Gemcitabine hydrochloride for injection, dosage: 1000mg/m², frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Cohort 1：Carboplatin and GemcitabineExperimental treatment 2 interventions
Group B: Cohort 2：BEBT-209 Capsules plus Chemotherapy (Carboplatin and Gemcitabine)Experimental treatment 3 interventions
Group C: Cohort 3：BEBT-209 Capsules plus Chemotherapy (Carboplatin and Gemcitabine)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival

Time frame
From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
2

AE

Adverse event

Time frame
From the first administration of the study drug to 28 days after the last administration of the study drug

Secondary outcomes

1

OS

Overall survival

Time frame
From date of administration until date of death from any cause,assessed up to 24 months.
2

ORR

Objective response rate

Time frame
During the treatment period, the first two assessments are conducted every 9 weeks, and starting from the third assessment, they are conducted every 12 weeks,assessed up to 24 months.
3

DCR

Disease control rate

Time frame
During the treatment period, the first two assessments are conducted every 9 weeks, and starting from the third assessment, they are conducted every 12 weeks,assessed up to 24 months.
4

TTR

Time to response

Time frame
During the treatment period, the first two assessments are conducted every 9 weeks, and starting from the third assessment, they are conducted every 12 weeks,assessed up to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeBetter Med Inc

Lead sponsor

Source ClinicalTrials.gov
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