Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With … (NCT01082211) | Clinical Trial Compass
CompletedPhase 2
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
United States65 participantsStarted 2010-06
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
Who can participate
Age range18 Years – 120 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types:
* Invasive ductal breast carcinoma
* Medullary ductal breast carcinoma
* Tubular ductal breast carcinoma
* Mucinous ductal breast carcinoma
* Lobular breast carcinoma
* Ductal carcinoma in situ (DCIS)
* No Paget disease of the nipple
* Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be \< 30% based on a post-operative, pre-treatment CT scan
* Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
* Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)
* Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension
* If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed:
* Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment
* Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified)
* Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented
* If the in-breast recurrence is invasive disease and:
* No prior ALN dissection or SLN dissection only:
* Patient is required to undergo axi…
What they're measuring
1
Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events