DETECT: Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC
Arms and Interventions
DNA demethylating agent decitabine plus carboplatin
decitabine 7mg/m2, d1-d5, q3w
carboplatin AUC = 6, d6, q3w
Primary Outcome Measures
- Overall response rate [At the end of Cycle 6 (each cycle is 21 days)]
Partial response (PR) + complete response (CR) rate
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.
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.
Contacts and Locations
|1||Ruijin Hospital, Shanghai Jiaotong University School of Medicine||Shanghai||Shanghai||China||200025|
Sponsors and Collaborators
- Shanghai Jiao Tong University School of Medicine
- Principal Investigator: Kunwei Shen, MD, Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
- Principal Investigator: Min Lu, PHD, Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
Study Documents (Full-Text)None provided.