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

NCT ID: NCT01150513

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EC-T

Group Type ACTIVE_COMPARATOR

EC-T

Intervention Type DRUG

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)

TP

Group Type EXPERIMENTAL

TP

Intervention Type DRUG

six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)

Interventions

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EC-T

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

TP

six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Peng Yuan

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

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Cancer Institute & Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Countries

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China

References

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Chen Y, Wang X, Du F, Yue J, Si Y, Zhao X, Cui L, Zhang B, Bei T, Xu B, Yuan P. Association between homologous recombination deficiency and outcomes with platinum and platinum-free chemotherapy in patients with triple-negative breast cancer. Cancer Biol Med. 2023 Mar 2;20(2):155-68. doi: 10.20892/j.issn.2095-3941.2022.0525.

Reference Type DERIVED
PMID: 36861447 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34648118 (View on PubMed)

Other Identifiers

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CH-BC-007

Identifier Type: -

Identifier Source: org_study_id

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