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

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00527293

Purpose

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.

Condition	Intervention
Breast Cancer	Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: brachytherapy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon [ Designated as safety issue: No ]
Patient satisfaction with partial breast irradiation as measured by a questionnaire [ Designated as safety issue: No ]
Wound healing and overall complication rate after partial breast irradiation [ Designated as safety issue: No ]
Determination of which patients are best suited for each individual technique of partial breast irradiation [ Designated as safety issue: No ]
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer, including the following histologic subtypes:
- Invasive ductal carcinoma
- Medullary ductal carcinoma
- Papillary ductal carcinoma
- Colloid (mucinous) ductal carcinoma
- Tubular ductal carcinoma
The following histologic subtypes are not allowed:
- Invasive lobular carcinoma
- Extensive lobular carcinoma in situ
- Ductal carcinoma in situ (DCIS)
- Nonepithelial breast malignancies, such as lymphoma or sarcoma
No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
- Lesion ≤ 3 cm
- No more than 3 positive lymph nodes
  - Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527293

Locations

United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422
Geauga Regional Hospital	Recruiting
Cleveland, Ohio, United States, 44024
Contact: Janice A Lyons 216-844-2536
Lake/University Ireland Cancer Center	Recruiting
Cleveland, Ohio, United States, 44060
Contact: Janice A Lyons 216-844-2536
Mercy Cancer Center at Mercy Medical Center	Recruiting
Cleveland, Ohio, United States, 44708
Contact: Janice A Lyons 216-844-2536
University Suburban Health Center	Recruiting
Cleveland, Ohio, United States, 44121
Contact: Janice A Lyons 216-844-2536
UHHS Chagrin Highlands Medical Center	Recruiting
Cleveland, Ohio, United States, 44122
Contact: Janice A Lyons 216-844-2536
UHHS Westlake Medical Center	Recruiting
Cleveland, Ohio, United States, 44145
Contact: Janice A Lyons 216-844-2536
Southwest General Health Center	Recruiting
Cleveland, Ohio, United States, 44130
Contact: Janice A Lyons 216-844-2536

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Janice Lyons

Ireland Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000564249, CASE-2104
Study First Received:	September 7, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00527293 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
invasive ductal breast carcinoma
medullary ductal breast carcinoma with lymphocytic infiltrate

mucinous ductal breast carcinoma
tubular ductal breast carcinoma
papillary ductal breast carcinoma

Study placed in the following topic categories:

Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms

Carcinoma, Ductal, Breast
Breast Diseases
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009