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A Pilot Clinical Trial to Evaluate High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Favorable Stage I and II Breast Cancer

45 Years
Not Enrolling
Breast Cancer

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Trial Information

A Pilot Clinical Trial to Evaluate High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Favorable Stage I and II Breast Cancer

- Radiation treatment will be delivered in an outpatient setting, twice a day in 5
consecutive treatment days. There will be a minimum 6-hour interval between the two
daily treatments. The applicator is a simple tube with an inflatable balloon at one
end, a channel in the middle of the tube for treatment, and two adapters at the other

- Following surgical removal of the breast cancer, the radiation oncologist with the
assistance of the surgeon or radiologist will place the applicator in the surgical
cavity. A small radioactive source, iridium-192, will be inserted into the applicator
by a special machine and after the final treatment, the applicator will be removed.

- The following procedures will be done while the patient is on radiation therapy:
post-partial mastectomy mammogram of micro-calcifications to confirm complete removal;
CT scans for radiation treatment planning; monitoring of the skin for side effects;
photographs of the breasts prior to the surgery, prior to placement of the applicator
and at 60 days after radiation treatment to evaluate the cosmetic outcome of the

- Participation in this study will last approximately 2 months after completion of
radiation treatment.

Inclusion Criteria:

- AJCC stage I or II histologically confirmed invasive ductal carcinoma of the breast
with a lesion < or = to 3cm, treated with partial mastectomy

- 45 years of age or older

- Negative inked pathologic specimen

- > or = to 3mm margins of partial mastectomy or re-excision specimen to be confirmed
prior to introducing radiation source

- Negative post-partial mastectomy or post re-excision mammography if cancer presented
with malignancy-associated microcalcifications; no remaining suspicious
microcalcifications in the breast before brachytherapy

- Invasive ductal, medullary, papillary, colloid, or tubular histologies

- Time interval from final definitive breast surgical procedure to brachytherapy
treatment is less than 8 weeks

Exclusion Criteria:

- Distant metastases

- Invasive lobular carcinoma or pure ductal carcinoma in situ or nonepithelial breast
malignancies such as sarcoma or lymphoma

- Proven multifocal, multicentric carcinoma with other clinically or radiologically
suspicious areas in the ipsilateral breast unless confirmed to be negative for
malignancy by biopsy

- Pregnant or lactating

- Confirmed positive axillary nodes in the ipsilateral axilla. Palpable or
radiographically suspicious contralateral axillary, supraclavicular, infraclavicular,
or internal mammary nodes, unless there is histologic confirmation that these nodes
are negative for tumor

- Prior non-hormonal therapy for the present breast cancer, including radiation therapy
and chemotherapy

- Collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma,
keloid, ataxia, telangiectasia, or dermatomyositis

- Co-existing medical condition in whom life expectancy is < 2 years

- Psychiatric or addictive disorders

- Paget's disease of the nipple

- Skin involvement regardless of size

- Breast unsatisfactory for brachytherapy

- Surgical margins which cannot be microscopically assessed or are positive at
pathological evaluation

- Extensive intraductal carcinoma

- Any previously treated contralateral breast carcinoma or synchronous bilateral breast

- Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation
in this study

- Diffuse suspicious microcalcifications

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the technical feasibility and acute 60-day toxicity of intracavitary HDR brachytherapy when used as the sole method of radiation therapy for patients with Stage I and II breast cancer.

Principal Investigator

Phillip M. Devlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2002

Completion Date:

October 2006

Related Keywords:

  • Breast Cancer
  • Intracavitary brachytherapy
  • radiation therapy
  • Stage I breast cancer
  • Stage II breast cancer
  • Breast Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115