Locoregional Control With Radiotherapy of Breast Cancer P... | NCT06378294

Studies
Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)

NCT06378294

Sponsor

University Hospital A Coruña

Status

Active, not recruiting

Last Update Posted

Mar 20, 2025Actual

Enrollment

82Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Mastectomy

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2021Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Apr 18, 2024

First Submission Date that Met QC Criteria

Apr 18, 2024

First Posted Date

Apr 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2025

Last Update Posted Date

Mar 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alberto Bouzon, Principal Investigator, M.D., Ph.D., University Hospital A CoruñaPrincipal Investigator

Lead Sponsor

University Hospital A CoruñaOTHER

Collaborators

Name	Class
Complejo Hospitalario Universitario de Pontevedra	OTHER
Complejo Hospitalario Universitario de Vigo	OTHER
Complejo Hospitalario Universitario de Santiago	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mastectomy patients		clinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy	Procedure: Mastectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mastectomy	Procedure	Adjuvant postmastectomy radiotherapy	Mastectomy patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free survival	recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death	3 and 5 years
Axillary recurrence rate	recurrence rate in the ipsilateral axillary lymph nodes	3 and 5 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	any cause of death as event	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with T1-2 primary invasive breast cancer
No suspicion of lymph node involvement prior to sentinel lymph node biopsy
Patients undergoing upfront mastectomy
Macrometastasis in not more than 2 lymph nodes at sentinel lymph node biopsy
Patients treated with adjuvant axillary radiotherapy

Exclusion Criteria:

Prior history of invasive breast cancer
Medical contraindication for radiotherapy
Medical contraindication for adjuvant systemic treatment
Planned neoadjuvant systemic treatment
Distant metastasis at initial diagnosis
Inability to absorb or understand the meaning of the study information

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Early-stage invasive breast cancer patients receiving upfront mastectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ALBERTO BOUZÓN	HOSPITAL UNIVERSITARIO A CORUÑA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Ferrol		Ferrol	A Coruña	15402	Spain
Hospital Universitario Santiago de Compostela

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28898379	Result	Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.
36383926

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases