The goal of this clinical trial is to evaluate therapeutic efficacy and safety of Chidamide combined with Cisplatin for relapsed or metastatic triple-negative breast cancer.
Triple-negative breast cancer (TNBC), the most difficult-to-treat breast cancer subtype, lacks well-defined treatment options. This is a prospective, single-center, one-arm, open-label, phase II clinical trial evaluating the efficacy and safety of chidamide in combination with cisplatin in subjects with relapsed or metastatic triple-negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 75mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGOverall response rate (ORR)
Defined as numbers of patients achieved complete response and partial response of treatment
Time frame: From the day of treatment to the date of first documented progression,up to 18 months after the last patient's enrollment
Progression-free survival (PFS)
Defined as the time from randomization until objective tumor progression or death
Time frame: From the day of treatment to the date of first documented progression,up to 18 months after the last patient's enrollment
Overall survival (OS)
Defined as from the date of inclusion to date of death, irrespective of cause
Time frame: From the day of treatment to the date of first documented progression,up to 18 months after the last patient's enrollment
Duration of remission (DOR)
Defined as from date of complete remission to date of progression, relapse, or death from any cause
Time frame: From the day of treatment to the date of first documented progression,up to 18 months after the last patient's enrollment
Clinical Benefit Rate (CBR)
Proportion of participants with a clinical benefit (CB), defined as an objective response (CR or PR), or stable disease for at least 24 weeks, as determined by the Investigator through the use of RECIST v1.1.
Time frame: From the day of treatment to the date of first documented progression,up to 18 months after the last patient's enrollment
Adverse event(AE)
Adverse event related to treatment
Time frame: From the day of treatment to the date of first documented progression,up to 18 months after the last patient's enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.