DETECT: Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT03295552

Collaborator

(none)

Enrollment

Location

Arm

42.5

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm	Drug: Decitabine Drug: Carboplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 15, 2017

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DC DNA demethylating agent decitabine plus carboplatin	Drug: Decitabine decitabine 7mg/m2, d1-d5, q3w Drug: Carboplatin carboplatin AUC = 6, d6, q3w

Arm

Intervention/Treatment

Experimental: DC

DNA demethylating agent decitabine plus carboplatin

Drug: Decitabine

decitabine 7mg/m2, d1-d5, q3w

Drug: Carboplatin

carboplatin AUC = 6, d6, q3w

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

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