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

Phase 0
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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


- 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


- No prior radiotherapy to the breast

- No chemotherapy for at least 2 weeks before and 2 weeks after completion of study

- Concurrent hormonal therapy allowed

Type of Study:


Study Design:

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

Outcome Measure:

Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon

Outcome Time Frame:

1 month after RT & Q3mos for one year

Safety Issue:


Principal Investigator

Janice Lyons, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2007

Completion Date:

October 2014

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms



Lake/University Ireland Cancer Center Mentor, Ohio  44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
UHHS Chagrin Highlands Medical Center Orange Villager, Ohio  44122
UHHS Westlake Medical Center Westlaker, Ohio  44145