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

Breast Cancer Clinical Trial

Official title:

Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01072838
• Other study ID #: S09-001
• Status: Terminated
• Phase: Phase 2
• First received: February 18, 2010
• Last updated: June 14, 2013
• Start date: December 2009
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: SenoRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01019720

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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(-)

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• APBI (Dose Escalation)
Accelerated, hypofractionated partial breast radiotherapy. 3 dose schemes followed for 6 months each.

Device:
• Contura MLB Breast Brachytherapy Catheter

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Virginia Commonwealth University	Richmond	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
SenoRx, Inc.	C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.		5 years	Yes