Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

36 Gy in 9 fractions BID x 4 1/2 treatment days

40 Gy in 10 fractions BID over 5 treatment days

Partial Breast Irradiation (PBI)

Imran Zoberi, M.D.

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.

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

Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer: A Phase I/II Feasibility Study

-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.

-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

* 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

-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 or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat.

* 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 for this study is the number of participants who remained free of disease in their breast.

-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

-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.

Washington University School of Medicine

36 Gy in 9 fractions BID x 4 1/2 treatment days

Partial Breast Irradiation (PBI)

Follow toxicities from Day 1 through Day 90

Cohort 1 (36 Gy) Acute Toxicities

Cohort 1 (36 Gy) Late Toxicities

40 Gy in 10 fractions BID over 5 treatment days

Partial Breast Irradiation (PBI)

Follow toxicities from Day 91 through end of follow-up

Cohort 2 (40 Gy) Acute Toxicities

Cohort 2 (40 Gy) Late Toxicities

36 Gy in 9 fractions BID x 4 1/2 treatment days

Partial Breast Irradiation (PBI)

Cohort 1 (36 Gy)

40 Gy in 10 fractions BID over 5 treatment days

Partial Breast Irradiation (PBI)

Cohort 2 (40 Gy)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan

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

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

2 patients in Cohort 1 were not evaluable for this outcome measure because 1 patient withdrew consent and 1 patient was lost to follow-up.

Incidence and Severity of Cutaneous Toxicity

Incidence of Breast Fibrosis

Incidence of Fat Necrosis

Excellent

Good

Fair

Poor

4 patients in Cohort 1 were not evaluable for this outcome measure because 2 patients did not have the cosmetic outcome performed, 1 patient withdrew consent, and 1 patient was lost to follow-up.

Spots Global Cancer Trial Database for Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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