Internal Radiation Therapy of the Breast in Treating Women With Early-Stage Breast Cancer
|Conditions:||Breast Cancer, Cancer|
|Age Range:||50 - Any|
|Start Date:||November 2009|
Safety and Feasibility of Short-course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near
a tumor to kill tumor cells. Giving radiation therapy through a special catheter that is
placed in the breast may kill any tumor cells that remain after surgery. It may also be an
effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well internal radiation therapy given through a
special catheter works in treating women with early-stage breast cancer.
- To determine local disease control in women with early-stage breast cancer treated with
shorter courses of accelerated partial-breast radiotherapy (APBI) delivered with a
breast brachytherapy applicator.
- To determine whether the acceptable toxicity rates of APBI can be preserved when
further accelerating the dose delivery scheme from the commonly applied ten treatments
delivered twice daily over 5 days to two treatments delivered over 2 days.
- To assess the rate of excellent or good cosmesis at 3 years after shorter courses of
- To identify covariants associated with and predictive of poor cosmetic outcome in
patients treated with an overnight course of APBI.
OUTLINE: This is a multicenter study.
Patients undergo placement of the Contura™ MLB device into the lumpectomy cavity followed by
CT scan for treatment planning. Approximately 1-5 days after balloon placement, patients
undergo accelerated partial-breast radiotherapy twice daily over 2 days.
After completion of study therapy, patients are followed up periodically for 5 years.
- Histologically confirmed ductal carcinoma in situ (DCIS) and/or invasive breast
- Stage Tis, T1, or T2 disease
- T2 tumor must be ≤ 3.0 cm in maximum diameter
- Must have undergone lumpectomy as surgical treatment of the breast
- Negative surgical margins by histology per NSABP criteria
- No surgical margins that cannot be microscopically assessed
- Patients with invasive breast cancer must have undergone an axillary staging
procedure by sentinel node biopsy alone or axillary dissection (with ≥ 6
axillary nodes removed)
- Axillary node(s) must be pathologically negative
- No Paget disease of the breast
- No prior DCIS or invasive breast cancer
- No multicentric carcinoma (DCIS or invasive)
- No synchronous bilateral invasive or non-invasive breast cancer
- Hormone-receptor status meeting 1 of the following criteria:
- Estrogen receptor (ER) positive tumor
- ER negative and progesterone receptor positive tumor
- Menopausal status not specified
- Life expectancy > 10 years (excluding diagnosis of breast cancer)
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active collagen vascular disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior breast or thoracic radiotherapy for any condition
We found this trial at
195 Little Albany St
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
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