|Recruiting||Breast Cancer||Phase III||
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
Histologically confirmed ductal carcinoma in situ (DCIS*) or invasive* adenocarcinoma of the breast
Stage 0, I, or II disease
- Stage II tumors must be ≤ 3 cm
Gross disease must be unifocal
- Microscopic multifocality allowed provided total pathological tumor size is ≤ 3 cm
- No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm
- No non-epithelial breast malignancies (e.g., sarcoma or lymphoma) NOTE: *Patients who are 50 years of age and over with DCIS regardless of hormone receptor status AND patients with invasive breast cancer meeting all of the following criteria: ≥ 50 years of age, node-negative, and hormone-receptor positive status will not be enrolled in study after 12/30/2006
Prior axillary staging required for patients with invasive breast cancer, including 1 of the following:
- Sentinel node biopsy alone (if sentinel node is negative)
- Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6 axillary nodes (if sentinel node is positive)
- Axillary dissection alone with ≥ 6 axillary nodes
No more than 3 positive axillary nodes
- No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
- No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes)
- No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
Must have undergone lumpectomy
- Resected margins histologically free of tumor
- Re-excision of surgical margins allowed
- Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative pre-randomization CT scan
- Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
- No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
- No Paget's disease of the nipple
No history of invasive breast cancer or DCIS
- Prior lobular carcinoma in situ treated by surgery alone allowed
- No synchronous bilateral invasive or non-invasive breast cancer
- Partial breast irradiation deemed technically deliverable by radiation oncologist at a credentialed facility
- Must have undergone a history and physical exam within the past 4 months AND a bilateral mammogram within the past 6 months
Hormone receptor status:
- Estrogen receptor (ER) status known
- Progesterone status known if ER analysis is negative
See this trial at ClinicalTrials.gov
Access protocol and consent forms at the Puget Sound Oncology Consortium site.
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.