Evaluation of Accelerated Partial Breast Brachytherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00593346
• Date of registration: 02/01/2008
• Primary sponsor: Washington University School of Medicine
• Public title: Evaluation of Accelerated Partial Breast Brachytherapy
• Scientific title: Evaluation of Accelerated Partial Breast Brachytherapy as the Sole Method of Radiation Therapy for Stage 0, 1 and II Lymph Node Negative Breast Cancer
• Date of first enrolment: December 2003
• Target sample size: 150
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00593346
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Imran Zoberi, MD
• Affiliation: Washington University School of Medicine

Key inclusion & exclusion criteria

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 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
carcinoma.

- 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
microcalcifications.

- Patients with suspicious microcalcifications remaining on the post-tylectomy
mammogram



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Radiation: brachytherapy

Primary Outcome(s)

The principal endpoint is the proportion of patients who remain free from an ipsilateral breast cancer recurrence 5 years after initial therapy [Time Frame: 9 years]

Secondary Outcome(s)

Secondary endpoints are quality of life, cosmesis, the presence or absence of complications, the occurrence of mastectomy after completion of initial breast-conserving treatment and the frequency of grade 3-4 toxicities. [Time Frame: The estimated patient acrual will take three to four year. Therefore, to obtain five year followup on all patient the study may take eight to nine years to complete.]

Secondary ID(s)

03-1205 / 201011816

Source(s) of Monetary Support

Please refer to primary and secondary sponsors