Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients (NCT04320979) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients
China2,400 participantsStarted 2020-05-08
Plain-language summary
The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy or breast-conserving surgery.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 breas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
disease-free survival
Timeframe: 5 years
Trial details
NCT IDNCT04320979
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences