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

Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01150513
Enrollment
320
Registered
2010-06-25
Start date
2009-06-30
Completion date
2016-04-30
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

TRIPLE-NEGATIVE, BREAST CANCER

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).

Interventions

DRUGEC-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)

DRUGTP

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

Sponsors

Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Disease Free Survival (DFS) of 3 years3 years after mastectomylocal recurrence, distant metastasis, the secondary primary malignancy

Secondary

MeasureTime frameDescription
Safety ProfilesUp to 24 weeksAll adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026