Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

Phase 2

Terminated

• Conditions: Breast Neoplasm
• Interventions: Drug: Decitabine; Drug: Carboplatin

• Registration Number: NCT03295552
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-28
• Study Start: 2017-11-15
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DC	Decitabine	DNA demethylating agent decitabine plus carboplatin
DC	Carboplatin	DNA demethylating agent decitabine plus carboplatin

Primary Outcome Measures

Name	Time	Method
Overall response rate	At the end of Cycle 6 (each cycle is 21 days)	Partial response (PR) + complete response (CR) rate

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China