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
• Status: Terminated
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

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)