Breast Cancer Clinical Trial
Official title:
Impact of Breast-Conserving Therapy (BCT) on Recurrence in Patients With Triple-Negative Breast Cancer (TNBC) Compared With Mastectomy
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.
STUDY POPULATION:
Operable patients with T1-2N0-1M0 triple-negative breast cancer
OBJECTIVES:
Primary To assess the impact of breast-conserving therapy on disease-free survival compared
with mastectomy in patients with T1-2N0-1M0 triple-negative breast cancer.
Secondary To assess the impact of breast-conserving therapy on locoregional recurrence-free
survival (LRRFS) and distant metastasis-free survival (DMFS) compared with mastectomy in
patients with T1-2N0-1M0 triple-negative breast cancer.
OUTLINE:
This is a prospective, randomized, open, single-center Phase III clinical study.
Patients undergo either lumpectomy or mastectomy with surgical axillary staging with all
lesions resected to negative margins based on the results of randomization generated by
computer.
Patients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen
respectively.
Since all tumors are smaller than 5cm and metastatic lymph nodes are less than 4, patients
undergoing mastectomy do not receive radiation therapy. On the hand, within 4-8 weeks after
completion of chemotherapy, patients undergoing breast-conserving surgery receive radiation
therapy as follows: (1) 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.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then 6 months for years 3-5.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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