Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2015-02-28

Brief Summary

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RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

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Detailed Description

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OBJECTIVES:

* To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.
* To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.
* To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.
* To evaluate wound healing and overall complication rate after partial breast irradiation.
* To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.

OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.

After completion of study therapy, patients are followed periodically for up to 5 years.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MammoSite Brachytherapy

Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

Group Type EXPERIMENTAL

adjuvant therapy

Intervention Type PROCEDURE

If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.

brachytherapy

Intervention Type RADIATION

Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

3-dimensional conformal radiotherapy

3-dimensional conformal radiotherapy twice daily for 5-10 days.

Group Type EXPERIMENTAL

adjuvant therapy

Intervention Type PROCEDURE

If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.

3-dimensional conformal radiation therapy

Intervention Type RADIATION

3-dimensional conformal radiotherapy twice daily for 5-10 days.

Interventions

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adjuvant therapy

If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.

Intervention Type PROCEDURE

3-dimensional conformal radiation therapy

3-dimensional conformal radiotherapy twice daily for 5-10 days.

Intervention Type RADIATION

brachytherapy

Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)

* Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin
* Unifocal breast cancer

* No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)

* No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
* No skin involvement of disease
* No Paget's disease of the nipple
* No distant metastatic disease
* Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Not pregnant or lactating
* Negative pregnancy test
* Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment
* No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
* No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
* No other malignancy within the past 5 years, except non-melanomatous skin cancer

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the breast
* No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy
* Concurrent hormonal therapy allowed

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No