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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

NCT05059379

Breast Cancer Radiotherapy; Complications Effect of Radiation Therapy

RECRUITING PHASE3

Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

NCT02240472

Breast Cancer

ACTIVE_NOT_RECRUITING NA

Sentinel Node Vs Observation After Axillary Ultra-souND

NCT02167490

Early Stage Breast Carcinoma

ACTIVE_NOT_RECRUITING NA

Axillary Lymph Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node

NCT01796444

Breast Cancer

WITHDRAWN PHASE3

Medico-economic Study of Three Strategies of Sentinel Lymph Node Analysis in Operable Breast Cancer

NCT02056886

Breast Cancer Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mastectomy patients

clinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy

Mastectomy

Intervention Type PROCEDURE

Adjuvant postmastectomy radiotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mastectomy

Adjuvant postmastectomy radiotherapy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Axillary radiotherapy without axillary lymph node dissection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No