A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced 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
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
Treatments tested in this trial
- BEBT-209 capsules
- Carboplatin injection
- Gemcitabine hydrochloride for injection
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov