Trials / Active Not Recruiting
Active Not RecruitingNCT06378294
Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)
Locoregional Control With Radiotherapy of cT1-2N0 Invasive Breast Cancer Patients With MACrometastases in the Sentinel Node Treated With MAstectomy: a Multi-center Observational Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 82 (actual)
- Sponsor
- University Hospital A Coruña · Academic / Other
- Sex
- Female
- Age
- 18 Years – 85 Years
- Healthy volunteers
- —
Summary
Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery. The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients. The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate.
Detailed description
This is a multi-center, prospective study with an estimated sample size of 60 early-stage IBC patients. Clinically node-negative T1-2 IBC patients undergoing mastectomy with up to 2 macrometases after SLNB will be informed about this study. Patients will be checked with annual mammography and clinical examination. The axilla will be checked with ultrasound at 3 and 5 years of the surgery. After surgery, patients will receive axillary radiotherapy, but no ALND, and adjuvant systemic treatment based on international guidelines.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Mastectomy | Adjuvant postmastectomy radiotherapy |
Timeline
- Start date
- 2021-04-20
- Primary completion
- 2024-12-31
- Completion
- 2029-12-31
- First posted
- 2024-04-22
- Last updated
- 2025-03-20
Locations
7 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT06378294. Inclusion in this directory is not an endorsement.