Breast-Conserving Therapy in Patients With Triple-Negative Breast Cancer
Breast-Conserving Therapy in Patients With Triple-Negative Breast Cancer
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.
Inclusion Criteria:

 1. Female aged 18 - 65 years old;

 2. Staging of Cancer: cT1-2N0-1M0;

 3. Histological confirmed with unilateral invasive carcinoma (all pathological types are
 applicable);

 4. Definite reports on ER/PR/Her2 receptor showing all ER/PR/Her2 negative (specific
 definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER
 negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+
 but determined negative via FISH or CISH detected (no amplification) is defined as
 Her2 negative);

 5. Newly diagnosed conditions allowing direct surgery without any absolute
 contraindication for surgery;

 6. ECOG performance score is 0 or 1;

 7. No mass or microscopic tumor residue after surgery resection;

 8. Informed consent form signed.

 9. Willing to return to enrolling institution for follow-up during the Active Monitoring
 Phase (the active treatment and observation portions) of the study.

 Exclusion Criteria:

 1. Bilateral breast cancer;

 2. Clinical or radiographic evidence of metastatic disease;

 3. Widespread disease that cannot be incorporated by local excision through a single
 incision that achieves negative margins with a satisfactory cosmetic result;

 4. Diffuse suspicious or malignant-appearing microcalcifications;

 5. Positive pathologic margin;

 6. Any of ER, PR or Her2 is positive;

 7. Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone
 therapy;

 8. Prior history of breast cancer or any other malignant disease (except for basal cell
 carcinoma and cervical carcinoma in situ);

 9. Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this
 study;

 10. Known allergic to taxane and anthracycline agents;

 11. Pregnant and breast-feeding women;

 12. With mental illness and cognitive impairment, unable to understand trial protocol and
 side effects and complete trial protocol and follow-ups;

 13. Without personal freedom and independent civil capacity.