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

NCT01581619 | Completed Results DMC

• 1 other identifier: 11-351
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Early Invasive N0; Non-Invasive

Outcome Measures

Primary Outcomes (1)

• 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. 1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. 2. The development of clinical fat necrosis. 3. 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 Outcomes (3)

• Local Control Rates

  2 years

• Distant Control Rates

  2 years

• Breast Cosmesis

  End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years

Study Arms (1)

Partial Breast Irradiation

EXPERIMENTAL

Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks

Radiation: External Beam Partial-Breast Irradiation

Interventions

External Beam Partial-Breast Irradiation RADIATION

40 Gy in ten daily fractions over two weeks

Partial Breast Irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (4)

Beth Isreal Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hosptial

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Alphonse Taghian, MD, PhD
• Organization: Massachusetts General Hospital

ATAGHIAN@mgh.harvard.edu

617-726-7559

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: April 20, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2019
• Last Updated: November 2, 2020
• Results First Posted: September 26, 2017

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)