breast cancer
Conditions
Interventions
Group 1:Mark the tumor and the original tumor bed before NAC using tissue markers (one clip at the center and other four clips at 4 edges). Conduct BCS per the original tumor bed (where the markers ar
Group 2:Mark the tumor with the tissue marker (1 clip at the center) before NAC. After NAC, conduct BCS per the residual tumor bed.
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The tumor is >= 3cm in diameter, and determined to be unicentric lesion by mammary MRI; 2. The subject desires BCS; 3. The resection margins are pathologically negative; 4. The subject achieved CR or PR after NAC by clinical evaluation; 5. Without absolute contraindications of BCS; 6. Provide informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject refused BCS before or after NAC; 2. The subject was clinically evaluated as SD or PD after NAC; 3. Detected local or distant neo lesion in pre-operative evaluation after NAC; 4. The resection margin or margins are pathologically positive; 5. Multicentric lesion; 6. With a medical history of malignant tumor; 7. Tumor infiltrated chest wall or skin, or inflammatory breast cancer; 8. With absolute contraindications as per the NCCN guideline; 9. Supraclavicular lymph nodes metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploration of tumor cells in primary tumor bed;Ipsilateral breast tumor recurrence (IBTR);The positive rates of margins of breast-conserving surgery identified by postoperative pathological examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local regional recurrence (LRR), including ipsilateral breast recurrence, chest wall/skin recurrence and ipsilateral axillary/supraclavicular/internal mammory lymph node recurrence;Distant metastasis;Disease-free survival (DFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactGuosheng Ren, Hongyuan Li, Xuedong Yin
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed