Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast (NCT06129747) | Clinical Trial Compass
RecruitingPhase 2
Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast
United States55 participantsStarted 2023-11-30
Plain-language summary
The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.
* Lesion size \< 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.
* Negative resection margins with at least no tumor on ink or a negative re-excision.
* Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest/abdomen and a bone scan or a PET scan.
* Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation.
* Participants must be \> 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study.
* Participants must have the ability to understand and t…
What they're measuring
1
Treatment-related adverse events as graded by CTCAE criteria
Timeframe: 1 year from the completion of re-irradiation