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

March 28, 2022 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

September 24, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBC1701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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