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

• Status: Not yet recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaoming Xie

Criteria

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.