External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks

A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer

Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed").

The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients.

The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: External Beam Partial-Breast Irradiation

Detailed Description

After signing the consent form, the following will be assessed.

-CT scan of the breast that had the cancer removed to help plan the radiation therapy. This is referred to as a CT-simulation. This scan is done routinely as part of the regular treatment.

PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over a 2 week period. During this time you will have a weekly interview, physical examination, and your skin will be assessed for any side effects of the radiation.

PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after chemotherapy (if you have been given chemotherapy).

After the final dose of the study:

You will have the following scheduled follow-up visits: one at the completion of the radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6 months for five years, and then once every year for the following five years after the completion of radiation therapy.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Isreal Deaconness Medical Center
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography
• Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen
• Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery

Exclusion Criteria:

• No distant metastasis
• Not pregnant or breastfeeding
• No diffuse suspicious microcalcifications
• No prior radiation therapy to the ipsilateral or contralateral breast or thorax
• No histologic evidence of lymphovascular invasion (LVI)
• No histologic evidence of EIC
• No history of cosmetic or reconstructive breast surgery
• No psychiatric illness that would prevent the patient from giving informed consent
• No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
• No other currently active second malignancy other than non-melanoma skin cancers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial Breast Irradiation; Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks	Radiation: External Beam Partial-Breast Irradiation; 40 Gy in ten daily fractions over two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks	The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.; Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.; The development of clinical fat necrosis.; The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically. The data is shown as the number of participants that experienced each of the specific toxicities.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control Rates	The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.	2 years
Distant Control Rates	The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.	2 years
Breast Cosmesis	Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.; Excellent: Little or no observable change; Good: Minimal but identifiable changes; Fair: Significant results of radiotherapy noted; Poor: Severe normal tissue sequelae	End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Non-Invasive; Early Invasive N0
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 11-351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO