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

Primary Purpose

Breast Neoplasm

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Decitabine
Carboplatin
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm focused on measuring decitabine, triple negative breast cancer, carboplatin, metastatic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DC

Arm Description

DNA demethylating agent decitabine plus carboplatin

Outcomes

Primary Outcome Measures

Overall response rate
Partial response (PR) + complete response (CR) rate

Secondary Outcome Measures

Full Information

First Posted
September 20, 2017
Last Updated
March 28, 2022
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03295552
Brief Title
Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC
Acronym
DETECT
Official Title
Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment.
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
decitabine, triple negative breast cancer, carboplatin, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DC
Arm Type
Experimental
Arm Description
DNA demethylating agent decitabine plus carboplatin
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
decitabine 7mg/m2, d1-d5, q3w
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
carboplatin AUC = 6, d6, q3w
Primary Outcome Measure Information:
Title
Overall response rate
Description
Partial response (PR) + complete response (CR) rate
Time Frame
At the end of Cycle 6 (each cycle is 21 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunwei Shen, MD
Organizational Affiliation
Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min Lu, PHD
Organizational Affiliation
Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

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