Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03295552

Acronym

DETECT

Enrollment

Registered

2017-09-28

Start date

2017-11-15

Completion date

2021-06-01

Last updated

2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Keywords

decitabine, triple negative breast cancer, carboplatin, metastatic

Brief summary

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

Interventions

DRUGDecitabine

decitabine 7mg/m2, d1-d5, q3w

DRUGCarboplatin

carboplatin AUC = 6, d6, q3w

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026