Could extra radiation after mastectomy keep breast cancer from coming back?
NCT ID NCT04320979
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving extra radiation to lymph nodes behind the breastbone can help prevent breast cancer from returning in high-risk patients. About 2,400 people who had a mastectomy and had cancer in their lymph nodes will take part. The goal is to see if this extra treatment improves how long they live without the cancer coming back.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
2,400 people
The number who actually took part.
- Started
-
May 2020
- Expected to finish
-
May 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Eastern Cooperative Oncology Group Performance Status Scale 0-2 * Histologically confirmed invasive breast cancer * Underwent total mastectomy/breast-conserving surgery and axillary dissection(10 or more axillary lymph nodes detected) and negative margins * Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1, IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy * No supraclavicular or internal mammary nodes metastases based on images before system therapy * No distant metastases * Could tolerate radiotherapy * Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles) * Anticipated to receive endocrine therapy for 5 years if indicated * Anticipated to receive anti-HER2 therapy for 1 years if indicated * LVEF≥50% based on echocardiogram * Willing to follow up * Written,informed consent Exclusion Criteria: * Simultaneous bilateral breast cancer * Sentinel lymph node biopsy only without axillary dissection * Had received internal mammary node dissection * No imaging assessment of the internal mammary nodal before system therapy * One-stage breast reconstruction * Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease * Had history of chest wall or supraclavicular radiotherapy * Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Can High-Risk breast cancer patients skip an extra radiation boost?
- Radioactive probe lights up CD73 on breast tumors in PET scans
- Can time with horses help cancer patients feel better?
- Can an oral drug replace injections for advanced breast cancer?
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?