Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378294
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-18
Brief Title:
Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy MACMA
Sponsor:
University Hospital A Coruña
Organization:
University Hospital A Coruña
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MACMA
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None