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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01581619
First received: January 11, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: External Beam Partial-Breast Irradiation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Safety of external-beam PBI utilizing 40Gy in ten daily fractions over two weeks [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    To evaluate 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.


Secondary Outcome Measures:
  • Evaluate local control rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate local control rates (analyzed separately for patients with DCIS and invasive cancer)

  • Evaluate distant control rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate distant control rates

  • Evaluate breast cosmesis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Breast Cosmesis will be assessed pretreatment, at the end of treatment, 4-9 weeks following completion of treatment, every 6 months for the first 5 years, then annually for 5 years. The Cosmetic Scoring System (Appendix 2) will be used.


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PBI
Partial Breast Irradiation
Radiation: External Beam Partial-Breast Irradiation
40 Gy in ten daily fractions over two weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581619

Contacts
Contact: Alphonse Taghian, MD, PhD 617-726-7559 ataghian@partners.org

Locations
United States, Massachusetts
Beth Isreal Deaconness Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Abram Recht, MD    617-667-2345    arecht@bidmc.harvard.edu   
Principal Investigator: Abram Recht, MD         
Brigham and Women's Hosptial Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Julia Wong, MD    617-632-3591    jwong@partners.org   
Principal Investigator: Julia Wong, MD         
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Julia Wong, MD    617-632-3591    jwong@partners.org   
Principal Investigator: Julia Wong, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alphonse Taghian, MD, PhD    617-726-7559    ataghian@partners.org   
Principal Investigator: Alphonse Taghian, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Alphonse Taghian, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01581619     History of Changes
Other Study ID Numbers: 11-351
Study First Received: January 11, 2012
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Early Invasive N0
Non-Invasive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014