Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB

SenoRx

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Device: Contura MLB Breast Brachytherapy Catheter; Radiation: APBI (Dose Escalation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01072838

S09-001

Details and patient eligibility

About

To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.

Enrollment: 60 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Life expectancy > 10 years
• Lumpectomy with clear margins (negative per NSABP criteria)
• DCIS and/or invasive carcinoma
• If invasive, nodes must be negative
• T stage is Tis, T1 or T2<=3 cm max diameter
• ER(+) or ER(-)/PR(+)

Exclusion criteria

• Pregnant or breast feeding
• Active collagen-vascular disease
• Paget's disease of the breast
• Prior history of breast cancer
• Prior breast or thoracic radiotherapy
• Multicentric carcinoma
• Synchronous bilateral breast cancer
• Surgical margins that cannot be assessed or that are positive
• T Stage is T2>3 cm or greater
• ER(-)/PR(-)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Dose Escalation

Other group

Treatment:

Device: Contura MLB Breast Brachytherapy Catheter

Radiation: APBI (Dose Escalation)