MedTrace Logo

Breast-Conserving Therapy in Patients With Triple-Negative Breast Cancer

NCT02464774 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2015-06-08

No results posted yet for this study

Summary

RATIONALE: Triple-negative breast cancer (TNBC) is an aggressive subtype shown to have a high risk of locoregional recurrence (LRR) and distant metastasis (DM). The equivalent impact of breast-conserving therapy (BCT) and mastectomy on disease-free survival in patients with early breast cancer has been established by a number of large randomized controlled trials and meta-analysis. However, ongoing dispute exists on whether TNBC is a good candidate for BCT.

PURPOSE: This prospective, randomized, open, single-center Phase III clinical study is conducted to compare efficacy and safety of breast-conserving therapy and mastectomy in treating Chinese patients with early TNBC.

Conditions

Interventions

PROCEDURE

Breast-Conserving Therapy

Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.

PROCEDURE

Mastectomy

Patients undergo mastectomy with surgical axillary staging with all lesions resected to negative margins.

DRUG

Adjuvant Chemotherapy

Patients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen respectively.

RADIATION

Radiation Therapy

N0: Radiation therapy to whole breast (+boost to tumor bed) or consideration of partial breast irradiation in selected patients; (2) N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.

Sponsors & Collaborators

  • Xiaoming Xie

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2022-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464774 on ClinicalTrials.gov