Status:
TERMINATED
Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03295552
Start Date
November 15 2017
End Date
June 1 2021
Last Update
April 6 2022
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025