Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer

Phase 1

Completed

• Conditions: Breast Neoplasms
• Interventions: Radiation: Partial Breast Irradiation (PBI)

• Registration Number: NCT00325598
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-02-14
• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-15
• Primary Completion: 2013-04-16
• Results First Submitted: 2016-09-19
• Results First Submitted QC: 2016-09-19
• Results First Posted: 2016-11-06
• Study Completion: 2017-04-16
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 (36 Gy)	Partial Breast Irradiation (PBI)	36 Gy in 9 fractions BID x 4 1/2 treatment days
Cohort 2 (40 Gy)	Partial Breast Irradiation (PBI)	40 Gy in 10 fractions BID over 5 treatment days

Primary Outcome Measures

Name	Time	Method
Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan	Within 1 year of protocol registration	-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity	Within 1 year of protocol registration	-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity

Secondary Outcome Measures

Name	Time	Method
Incidence of Breast Fibrosis	Up to 5 years
Cosmetic Outcome	Up to 5 years	* Excellent: little or no observable change; * Good: minimal but identifiable changes; * Fair: significant results of radiotherapy noted; * Poor: severe normal tissue sequelae
Local Control Rate	Up to 5 years	-Local control rate for this study is the number of participants who remained free of disease in their breast.
Distant Control Rate	Up to 5 years	-Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes.
Incidence and Severity of Cutaneous Toxicity	Up to 5 years	* Uses RTOG/EORTC Late Radiation Morbidity Scoring Scheme; * Grade 0 = none; * Grade 1 = slight atrophy; pigmentation change; some hair loss; * Grade 2 = patch atrophy; moderate telangiectasia; total hair loss; * Grade 3 = marked atrophy; gross telangiectasia; * Grade 4 = ulceration; * Worst cutaneous toxicity grade is noted
Incidence of Fat Necrosis	Up to 5 years	-Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate ...
Regional Control Rate	Up to 5 years	-Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States