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

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ClinicalTrials.gov Identifier: NCT00527293
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : August 25, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: brachytherapy Early Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
Study Start Date : June 2007
Primary Completion Date : October 2010
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon [ Time Frame: 1 month after RT & Q3mos for one year ]
  2. Patient satisfaction with partial breast irradiation as measured by a questionnaire [ Time Frame: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr ]
  3. Wound healing and overall complication rate after partial breast irradiation [ Time Frame: 1 month after RT & Q3mos for one year ]
  4. Determination of which patients are best suited for each individual technique of partial breast irradiation [ Time Frame: Patients will be followed for a period of five years following completion of radiation. ]
  5. Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates [ Time Frame: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527293


Locations
United States, Ohio
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Janice Lyons, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00527293     History of Changes
Other Study ID Numbers: CASE2104
P30CA043703 ( U.S. NIH Grant/Contract )
CASE2104 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases