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Evaluation of Accelerated Partial Breast Brachytherapy as the Sole Method of Radiation Therapy for Stage 0, 1 and II Lymph Node Negative Breast Carcinoma

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Evaluation of Accelerated Partial Breast Brachytherapy as the Sole Method of Radiation Therapy for Stage 0, 1 and II Lymph Node Negative Breast Carcinoma

This study will evaluate the local control, cosmetic results, quality of life, and
complication rates of brachytherapy when used as the sole method of radiation therapy for
patients with stage 0,I, and II carcinoma of the breast treated with tylectomy, with
histologically assessed negative surgical margins, N0 axillary nodes.

Inclusion Criteria:

- AJCC stage 0, I, or II (TisN0, T1N0, T2N0 = 3 cm) histologically confirmed carcinoma
of the breast, treated with tylectomy. Axillary sampling is required only for cases
of invasive cancers. Tumor size is determined by the pathologist. Clinical size may
be used if the pathologic size is indeterminate.

- Signed study-specific informed consent for participation in the study.

- Negative, or close but negative, inked histologic margins of tylectomy or reexcision
specimen to be confirmed prior to placing the brachytherapy catheters. Margins
generally are positive if there is invasive or noninvasive tumor at the inked
resection margin, close but negative if the tumor is within 2 mm of the inked margin
and negative if the tumor is at least 2 mm away from the inked edge.

- Negative post-tylectomy or post-reexcision mammography if cancer presented with
malignancy-associated microcalcifications; no remaining suspicious
microcalcifications in the breast before brachytherapy.

- For patients with invasive cancer, no positive axillary lymph nodes with at least 6
axillary lymph nodes sampled or a negative sentinel node.

- Invasive ductal, lobular, medullary, papillary, colloid (mucinous),or tubular
histologies. Noninvasive ductal carcinoma in situ.

- Chemotherapy or hormonal therapy planned for = 2 weeks after removal of brachytherapy
catheters is permitted. Hormonal therapy is allowed during brachytherapy at treating
radiation oncologist's decision.

- Negative pregnancy test for premenopausal patients with an intact uterus

Exclusion Criteria:

- Patients with distant metastases.

- Patients with in-situ lobular carcinoma or nonepithelial breast malignancies such as
sarcoma or lymphoma.

- Patients with proven multicentric carcinoma (tumors in different quadrants of the
breast, or tumors separated by at least 4 cm) with other clinically or
radiographically suspicious areas in the ipsilateral breast unless confirmed to be
negative for malignancy by biopsy.

- Patients who are pregnant or lactating.

- Patients with histologically 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
or chemotherapy.

- Patients with systemic lupus erythematosis, scleroderma, or dermatomyositis with a
CPK level above normal or with an active skin rash.

- Patients with coexisting medical conditions in whom life expectancy is < 2 years.

- Patients with psychiatric or addictive disorders that would preclude obtaining
informed consent or completing the full series of high dose rate brachytherapy
treatments on an outpatient basis.

- Patients with Paget's disease of the nipple.

- Patients with skin involvement, regardless of tumor size.

- Patients with a breast unsatisfactory for brachytherapy. For example, if there is
little breast tissue remaining between the skin and pectoralis muscle after surgery,
placement of catheters is technically problematic.

- Patients with tylectomies so extensive that the cosmetic result is fair or poor prior
to brachytherapy.

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

- 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; the disease free interval from any prior carcinoma must be continuous.

- Time between final definitive breast procedure to radioactive source loading of the
brachytherapy catheters is greater than 8 weeks.

- Patients with diffuse (> 1 quadrant or >5 cm in diameter) suspicious

- Patients with suspicious microcalcifications remaining on the post-tylectomy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who are free of breast cancer in the treated breast and regional lymph nodes after initial therapy.

Outcome Time Frame:

5 years after treatment completion

Safety Issue:


Principal Investigator

Imran Zoberi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:

03-1205 / 201011816



Start Date:

December 2003

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110