Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC (DETECT)

Shanghai Jiao Tong University School of Medicine

Status and phase

Terminated

Phase 2

Conditions

Breast Neoplasm

Treatments

Drug: Carboplatin

Drug: Decitabine

Study type

Interventional

Funder types

Other

Identifiers

RJBC1701

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No 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.