Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer (NCT03583580) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer
China537 participantsStarted 2018-07-19
Plain-language summary
This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.
Who can participate
Age range
45 Years – 75 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:
* Life Expectation: \> 5 years
* Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
* Unifocal tumour (confirmed by diagnostic MRI)
* No lymphovascular invasion
* ER positive (defined as medium-strongly nuclear staining in \>1% of the cancer cells)
* Negative radial resection margins of \>= 2 mm
* Surgical clips placed in the tumor bed
* Written informed consent.
Exclusion Criteria:
* Stage Ⅱ-Ⅲ
* Multifocal tumors
* Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
* Paget's disease of the nipple
* Underwent oncoplastic surgery of ipsilateral breast
* Underwent neoadjuvant chemotherapy or hormonal therapy
* Previous or simultaneous contralateral breast cancer
* Undergone ipsilateral chest wall radiotherapy
* Active collagen vascular disease.
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
locoregional control rate
Timeframe: 5 years
Trial details
NCT IDNCT03583580
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences