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

NCT01150513 | Completed Phase 2

• 1 other identifier: CH-BC-007
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

TRIPLE-NEGATIVE; BREAST CANCER

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival (DFS) of 3 years

  local recurrence, distant metastasis, the secondary primary malignancy

  3 years after mastectomy

Secondary Outcomes (1)

• Safety Profiles

  Up to 24 weeks

Study Arms (2)

EC-T

ACTIVE COMPARATOR

Drug: EC-T

TP

EXPERIMENTAL

Drug: TP

Interventions

EC-T 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)

EC-T

TP DRUG

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

TP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute & Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (2)

• 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.

  PMID: 36861447 DERIVED

• 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.

  PMID: 34648118 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peng Yuan, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 25, 2010
• Study Start: June 1, 2009
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

CN (1)