Breast Cancer Clinical Trial

Use of the Conturaâ„¢ Catheter to Deliver Accelerated Partial Breast Irradiation to “Low-risk” Breast Cancer Patients

Summary

The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.

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Full Description

The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.

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Eligibility Criteria

Inclusion Criteria:

Able and willing to sign informed consent
Age 50 or older at diagnosis
Life expectancy greater than 10 years (excluding diagnosis of breast cancer)
Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria)
On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma
For patients with invasive breast cancer, an axillary staging procedure must be performed [either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative]
The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter
Estrogen receptor positive tumor

Exclusion Criteria:

Age < 50 at diagnosis (regardless of histology)
Pregnant or breast-feeding
Active collagen vascular disease
Paget's disease of the breast
Prior history of DCIS or invasive breast cancer
Prior breast or thoracic radiation therapy for any condition
Multicentric carcinoma (DCIS or invasive)
Synchronous bilateral invasive or non-invasive breast cancer
Surgical margins that cannot be microscopically assessed or that are positive
Positive axillary node(s)
T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage of T3 or T4
Estrogen receptor negative tumor

Study is for people with:

Breast Cancer

Phase:

Phase 4

Estimated Enrollment:

30

Study ID:

NCT00882596

Recruitment Status:

Completed

Sponsor:

Cancer Center of Irvine

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There is 1 Location for this study

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Cancer Center of Irvine
Irvine California, 92618, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 4

Estimated Enrollment:

30

Study ID:

NCT00882596

Recruitment Status:

Completed

Sponsor:


Cancer Center of Irvine

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