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Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
EC-T
TP
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring TRIPLE-NEGATIVE, BREAST CANCER

Eligibility Criteria

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

Inclusion Criteria:

  • Triple-negative breast cancer
  • Older than 18 years old
  • Have tumor resection surgery
  • Sufficient organ function (marrow, heart, liver)

Exclusion Criteria:

  • Other malignancy
  • Other serious disease( marrow, heart, liver)

Sites / Locations

  • Cancer Institute & Hospital Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EC-T

TP

Arm Description

Outcomes

Primary Outcome Measures

Disease Free Survival (DFS) of 3 years
local recurrence, distant metastasis, the secondary primary malignancy

Secondary Outcome Measures

Safety Profiles
All adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities.

Full Information

First Posted
June 14, 2010
Last Updated
February 5, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01150513
Brief Title
Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Official Title
Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
TRIPLE-NEGATIVE, BREAST CANCER

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EC-T
Arm Type
Active Comparator
Arm Title
TP
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EC-T
Intervention Description
four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide :600 mg/m2, day 1) followed by four cycles of T (docetaxel : 75 mg/m2 or paclitaxel 175 mg/m2, day 1)
Intervention Type
Drug
Intervention Name(s)
TP
Intervention Description
six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)
Primary Outcome Measure Information:
Title
Disease Free Survival (DFS) of 3 years
Description
local recurrence, distant metastasis, the secondary primary malignancy
Time Frame
3 years after mastectomy
Secondary Outcome Measure Information:
Title
Safety Profiles
Description
All adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities.
Time Frame
Up to 24 weeks

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: Triple-negative breast cancer Older than 18 years old Have tumor resection surgery Sufficient organ function (marrow, heart, liver) Exclusion Criteria: Other malignancy Other serious disease( marrow, heart, liver)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, MD
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute & Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34648118
Citation
Zheng F, Du F, Wang W, Wang Y, Li M, Zhao J, Wang X, Yue J, Wang J, Yang Z, Cai R, Ma F, Fan Y, Li Q, Zhang P, Xu B, Yuan P. Updated efficacy of adjuvant epirubicin plus cyclophosphamide followed by taxanes versus carboplatin plus taxanes in early triple-negative breast cancer in phase 2 trial: 8.1-year median follow-up. Breast Cancer Res Treat. 2022 Jan;191(1):97-105. doi: 10.1007/s10549-021-06401-6. Epub 2021 Oct 14.
Results Reference
derived

Learn more about this trial

Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

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