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)
12
Enrollment
1
Location
1
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

  1. 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:
No
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

SiteCityStateCountryPostal Code
1Ruijin Hospital, Shanghai Jiaotong University School of MedicineShanghaiShanghaiChina200025

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kunwei Shen, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT03295552
Other Study ID Numbers:
  • RJBC1701
First Posted:
Sep 28, 2017
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kunwei Shen, Professor, Shanghai Jiao Tong University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022