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

Breast Cancer Clinical Trial

Official title:

Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527293
• Other study ID #: CASE2104
• Secondary ID: P30CA043703CASE2
• Status: Completed
• Phase: Phase 0
• First received: September 7, 2007
• Last updated: August 21, 2015
• Start date: June 2007
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2015
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• 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.

Radiation:
• 3-dimensional conformal radiation therapy
3-dimensional conformal radiotherapy twice daily for 5-10 days.
• brachytherapy
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Lake/University Ireland Cancer Center	Cleveland	Ohio
United States	UHHS Chagrin Highlands Medical Center	Cleveland	Ohio
United States	UHHS Westlake Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon		1 month after RT & Q3mos for one year	No
Primary	Patient satisfaction with partial breast irradiation as measured by a questionnaire		Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr	No
Primary	Wound healing and overall complication rate after partial breast irradiation		1 month after RT & Q3mos for one year	No
Primary	Determination of which patients are best suited for each individual technique of partial breast irradiation		Patients will be followed for a period of five years following completion of radiation.	No
Primary	Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates		Ipsilateral breast 6 mos after dx, bilateral annually x 5 years	No