Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Azacitidine; Carboplatin; Decitabine

Criteria

Inclusion Criteria:

• Female aged between 18 years and 70 years old.

• Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-.

• Metastatic TNBC should not be treated with more than 1-line for metastatic disease.

• Patients can not be treated with carboplatin in the metastatic setting.

• For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting.

• Patients had at least one measurable lesion according to RECIST criteria version 1.1.

• ECOG Performance Status (PS) of 0-1.

• Adequate liver and renal organ function.

• Dated and signed IEC/IRB-approved informed consent.

Exclusion Criteria:

• More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and other therapies to treat bone metastases.

• Less than four weeks since last radiotherapy.

• Pregnancy or lactation or unwillingness to use adequate method of birth control.

• Active or uncontrolled infection.

• Hypersensitivity to carboplatin or decitabine

• Male breast cancer.

• Treated with any DNA demethylating agents

• Young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.