Randomized Trial of Accelerated Partial Breast Irradiation (NCT03583619) | Clinical Trial Compass
CompletedNot Applicable
Randomized Trial of Accelerated Partial Breast Irradiation
China140 participantsStarted 2017-07-19
Plain-language summary
This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.
Who can participate
Age range45 Years – 75 Years
SexFEMALE
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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 â…¡-â…¢
* 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.
What they're measuring
1
Number o participants with Grade 2 or more toxicity
Timeframe: 5 years
Trial details
NCT IDNCT03583619
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences