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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
adjuvant therapy
3-dimensional conformal radiation therapy
brachytherapy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lake/University Ireland Cancer Center
  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  • UHHS Chagrin Highlands Medical Center
  • UHHS Westlake Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MammoSite Brachytherapy

3-dimensional conformal radiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
Patient satisfaction with partial breast irradiation as measured by a questionnaire
Wound healing and overall complication rate after partial breast irradiation
Determination of which patients are best suited for each individual technique of partial breast irradiation
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates

Secondary Outcome Measures

Full Information

First Posted
September 7, 2007
Last Updated
August 21, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00527293
Brief Title
Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
Official Title
Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MammoSite Brachytherapy
Arm Type
Experimental
Arm Description
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
Arm Title
3-dimensional conformal radiotherapy
Arm Type
Experimental
Arm Description
3-dimensional conformal radiotherapy twice daily for 5-10 days.
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Description
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
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Intervention Description
3-dimensional conformal radiotherapy twice daily for 5-10 days.
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Description
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
Primary Outcome Measure Information:
Title
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
Title
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
Title
Wound healing and overall complication rate after partial breast irradiation
Time Frame
1 month after RT & Q3mos for one year
Title
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.
Title
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates
Time Frame
Ipsilateral breast 6 mos after dx, bilateral annually x 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Lyons, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Lake/University Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
UHHS Chagrin Highlands Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
UHHS Westlake Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States

12. IPD Sharing Statement

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

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