Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

This is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast.

A dose of 40 Gy will be delivered to the tumor bed plus 1.5-2 cm margin. Treatment will be delivered once daily, 5 days a week, for approximately 2 weeks. Radiation therapy will begin within a minimum of 4 weeks and a maximum of 3 months from definitive surgical procedure and 2-6 weeks after chemotherapy, if chemotherapy given first. Prior to radiation, patients will receive a lumpectomy with an assessment of axillary lymph node status (for invasive tumors only). Axillary assessment may be any combination of sentinel lymph node biopsy or axillary lymph node dissection.

multiple beams utilizing either intensity-modulated or 3D-conformal techniques

Simon Powell, MD

Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast.

However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI.

WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks.

In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.

Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer

A Phase II Study of Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer

In selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions for two weeks.

(local control for patients with DCIS will be analyzed separately from those patients with invasive cancer)

Memorial Sloan Kettering Cancer Center

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer	NCT01203839	Breast Cancer	multiple beams ...	18 Years -	Memorial Sloan Kettering Cancer Center
Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer	NCT00325598	Breast Neoplasm...	Partial Breast ...	18 Years -	Washington University School of Medicine
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer	NCT01203839	Breast Cancer	multiple beams ...	18 Years -	Memorial Sloan Kettering Cancer Center
Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer	NCT01203839	Breast Cancer	multiple beams ...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for partial breast irradiation (pbi)