Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

Not Applicable

Completed

• Conditions: Long-term Effects Secondary to Cancer Therapy in Adults; Skin Reactions Secondary to Radiation Therapy; Breast Cancer
• Interventions: Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: 3-dimensional conformal radiation therapy; Radiation: brachytherapy; Radiation: intracavitary balloon brachytherapy; Radiation: proton beam radiation therapy

• Registration Number: NCT00599989
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.

Detailed Description

OBJECTIVES:

* To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.

* To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.

* To summarize the institutional experience of these patients treated with this experimental therapy.

OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).

After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-24
• Primary Completion: 2009-05-11
• Study Completion: 2009-05-11
• Status Verified: 2019-04
• Disposition First Submitted: 2020-04-06
• Disposition First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Disposition First Posted: 2020-04-09
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APBI	adjuvant therapy	-
APBI	brachytherapy	-
APBI	conventional surgery	-
APBI	3-dimensional conformal radiation therapy	-
APBI	intracavitary balloon brachytherapy	-
APBI	proton beam radiation therapy	-

Primary Outcome Measures

Name	Time	Method
Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy	11 months

Secondary Outcome Measures

Name	Time	Method
Time to recurrence	11 months
Time to locoregional recurrence	11 months
Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up	11 months
Site of disease recurrence (i.e., local, regional, or distant)	11 months

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States