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NCT03295552 Clinical Trial

Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

Breast Neoplasm Clinical Trial

— DETECT  

Official title:
Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03295552
Other study ID # RJBC1701
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 15, 2017
Est. completion date June 1, 2021

Study information
Verified date March 2022
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Decitabine
decitabine 7mg/m2, d1-d5, q3w
• Carboplatin
carboplatin AUC = 6, d6, q3w

Locations
Country Name City State
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall response rate Partial response (PR) + complete response (CR) rate At the end of Cycle 6 (each cycle is 21 days)
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