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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: adjuvant therapy; Radiation: brachytherapy; Radiation: 3-dimensional conformal radiation therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44060
      • Lake/University Ireland Cancer Center
    • Cleveland, Ohio, United States, 44122
      • UHHS Chagrin Highlands Medical Center
    • Cleveland, Ohio, United States, 44145
      • UHHS Westlake Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MammoSite Brachytherapy; Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days	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: brachytherapy; Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
Experimental: 3-dimensional conformal radiotherapy; 3-dimensional conformal radiotherapy twice daily for 5-10 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon	1 month after RT & Q3mos for one year
Patient satisfaction with partial breast irradiation as measured by a questionnaire	Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr
Wound healing and overall complication rate after partial breast irradiation	1 month after RT & Q3mos for one year
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.
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates	Ipsilateral breast 6 mos after dx, bilateral annually x 5 years

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Janice Lyons, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: September 7, 2007
• First Submitted That Met QC Criteria: September 7, 2007
• First Posted (Estimate): September 10, 2007

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: stage II breast cancer; stage I breast cancer; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE2104 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract)