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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01581619
Recruitment Status : Active, not recruiting
First Posted : April 20, 2012
Results First Posted : September 26, 2017
Last Update Posted : November 27, 2019
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Alphonse Taghian, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: External Beam Partial-Breast Irradiation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2012
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks [ Time Frame: 2 years ]

    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.

Secondary Outcome Measures :
  1. Local Control Rates [ Time Frame: 2 years ]
    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. Distant Control Rates [ Time Frame: 2 years ]
    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.

  3. Breast Cosmesis [ Time Frame: End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581619

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

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Responsible Party: Alphonse Taghian, MD, PhD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01581619    
Other Study ID Numbers: 11-351
First Posted: April 20, 2012    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alphonse Taghian, MD, PhD, Massachusetts General Hospital:
Early Invasive N0
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases