Overview
Breast-Conserving Therapy in Patients With Triple-Negative Breast Cancer
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Female
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/AAccepts Healthy Volunteers?
NoDetails
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.