Status:
RECRUITING
Selective Omission of Axillary Surgery in Triple-negative and HER2-positive Breast Cancer After NACT
Lead Sponsor:
Peking University
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
Neoadjuvant chemotherapy (NACT) is standard treatment for many triple-negative (TNBC) and HER2-positive breast cancer. Study showed about half of the biopsy-proven axillary disease will be eradicated ...
Eligibility Criteria
Inclusion
- Written informed consent
- Core biopsy confirmed unicentric primary invasive triple-negative or HER2-positive breast cancer. Multifocal or multicentric tumors allowed only if breast-conserving surgery is deemed feasible.
- At least 18 years of age
- Initial tumor stage cT1c-T3N0M0 prior to NACT. cN0 stage established by clinical examination and ultrasonography
- In cases with suspicious lymph node, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required
- Standard NACT with evident radiologic response
- Planned breast-conserving surgery with postoperative external whole-breast irradiation
Exclusion
- History of previous malignancy
- Histologically proven N1 patients, patients with distant metastasis (M1)
- Pregnant or lactating patients
- Inflammatory breast cancer
- Radiologically non-responsive after NACT
- Mastectomy planned after NACT
- planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques
- Written informed consent not obtained
Key Trial Info
Start Date :
July 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05314114
Start Date
July 3 2020
End Date
September 1 2028
Last Update
April 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142