Breast CancerMACMANCT06378294
Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)
An observational study of Breast Cancer, run by University Hospital A Coruña at 7 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 7 sitesSpain
- Study dates
- 20 Apr 2021to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Adult, Older adult
Study population: Early-stage invasive breast cancer patients receiving upfront mastectomy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitario A Coruña
A Coruña, 15006
Hospital Universitario Ferrol
Ferrol, A Coruña, 15402
Hospital Universitario Lugo
Lugo, 27003
Hospital Universitario Ourense
Ourense, 32005
Hospital Universitario Pontevedra
Pontevedra, 36071
Hospital Universitario Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Hospital Universitario Vigo
Vigo, Pontevedra, 36214
About this study
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
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.
Read the 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
- Breast Cancer
- Being tested
- Mastectomy
- Keywords
- axillary radiotherapy, mastectomy, sentinel lymph node biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastectomyProcedure or surgery
Also called Axillary radiotherapy without axillary lymph node dissection
Adjuvant postmastectomy radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Mastectomy patients | clinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy Receives: Procedure: Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death
Measured: 3 and 5 years
Axillary recurrence rate
recurrence rate in the ipsilateral axillary lymph nodes
Measured: 3 and 5 years
Secondary outcomes (1)
Overall survival
any cause of death as event
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start20 Apr 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital A Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Pontevedra, Complejo Hospitalario Universitario de Vigo, Complejo Hospitalario Universitario de Santiago, Hospital Universitario Lucus Augusti, Complexo Hospitalario de Ourense, Hospital Arquitecto Marcide
- Responsible party
- Principal investigator, Alberto Bouzon, University Hospital A Coruña
- Investigators
- ALBERTO BOUZÓN, Principal investigator, HOSPITAL UNIVERSITARIO A CORUÑA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378294
- Sponsor's protocol ID
- UHACoruna
- Acronym
- MACMA
- Status last verified
- Mar 2025
- First submitted
- 18 Apr 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published by the investigators in academic journals
Publications
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.
PubMed 28898379Bartels SAL, Donker M, Poncet C, Sauve N, Straver ME, van de Velde CJH, Mansel RE, Blanken C, Orzalesi L, Klinkenbijl JHG, van der Mijle HCJ, Nieuwenhuijzen GAP, Veltkamp SC, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JWS, Belkacemi Y, Petignat P, Schinagl DAX, Coens C, van Tienhoven G, van Duijnhoven F, Rutgers EJT. Radiotherapy or Surgery of the Axilla After a Positive Sentinel Node in Breast Cancer: 10-Year Results of the Randomized Controlled EORTC 10981-22023 AMAROS Trial. J Clin Oncol. 2023 Apr 20;41(12):2159-2165. doi: 10.1200/JCO.22.01565. Epub 2022 Nov 16.
PubMed 36383926
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06378294
- Acronym / sponsor ID
- MACMA / UHACoruna
- Conditions
- Breast Cancer
- Keywords
- axillary radiotherapy, mastectomy, sentinel lymph node biopsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital A CoruñaUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Pontevedra, Complejo Hospitalario Universitario de Vigo, Complejo Hospitalario Universitario de Santiago, Hospital Universitario Lucus Augusti, Complexo Hospitalario de Ourense, Hospital Arquitecto Marcide
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mastectomy patients | – | Procedure: Mastectomyclinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Early-stage invasive breast cancer patients receiving upfront mastectomy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MastectomyAlso: Axillary radiotherapy without axillary lymph node dissectionAdjuvant postmastectomy radiotherapy | Procedure or surgery | Mastectomy patients |
Primary outcome
Disease-free survival
Time frame: 3 and 5 years
recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death
Axillary recurrence rate
Time frame: 3 and 5 years
recurrence rate in the ipsilateral axillary lymph nodes
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Results publication: PubMed 28898379Giuliano 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.
- Results publication: PubMed 36383926Bartels SAL, Donker M, Poncet C, Sauve N, Straver ME, van de Velde CJH, Mansel RE, Blanken C, Orzalesi L, Klinkenbijl JHG, van der Mijle HCJ, Nieuwenhuijzen GAP, Veltkamp SC, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JWS, Belkacemi Y, Petignat P, Schinagl DAX, Coens C, van Tienhoven G, van Duijnhoven F, Rutgers EJT. Radiotherapy or Surgery of the Axilla After a Positive Sentinel Node in Breast Cancer: 10-Year Results of the Randomized Controlled EORTC 10981-22023 AMAROS Trial. J Clin Oncol. 2023 Apr 20;41(12):2159-2165. doi: 10.1200/JCO.22.01565. Epub 2022 Nov 16.
- Individual participant dataSharing planned: No. Results will be published by the investigators in academic journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALBERTO BOUZÓN principal investigator
HOSPITAL UNIVERSITARIO A CORUÑA
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Hospital A Coruña at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 3 and 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06378294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.