Internal Radiation Therapy of the Breast in Treating Women With Early-Stage Breast Cancer

Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:50 - Any
Start Date:November 2009

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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


- 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
(732) 235-2465
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
New Brunswick, NJ
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