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Trial record 3 of 4 for:    NSABP B39 BREAST

Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)

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.
ClinicalTrials.gov Identifier: NCT02272400
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.

Condition or disease Intervention/treatment
Breast Cancer Other: IGRT for prone partial breast irradiation (PBI)

Detailed Description:
Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of LDR brachytherapy).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)
Actual Study Start Date : August 7, 2007
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IGRT of prone partial breast
IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy.
Other: IGRT for prone partial breast irradiation (PBI)
IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.
Other Names:
  • IGRT
  • PBI

Outcome Measures

Primary Outcome Measures :
  1. Measure the outcome of applying IGRT to PBI [ Time Frame: 10 years ]

    Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting.

    Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field

Secondary Outcome Measures :
  1. Feasibility of accelerated dose fractionation [ Time Frame: 1 - 10 years ]
    Assess the feasibility of an accelerated dose fractionation (600 cGy x 5) when given over five consecutive day by measuring the acute and late radiation toxicity

  2. Genetic pre-disposition of patient to post-treatment radiation fibrosis [ Time Frame: 1 - 10 years ]
    Prospectively determine if genetic factors can be identified which may predispose a patient to the development of post-treatment radiation fibrosis

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Post-menopausal women defined as either:

    1. at least 2 years without menstrual period or
    2. patients older than 50 with serological evidence of post-menopausal status or
    3. hysterectomized patients of any age with FSH confirmation of post-menopausal status
  • pT1 breast cancer, excised with negative margins
  • pN0 or sentinel node negative or N0 clinically if the tumor is < 1 cm in size

Exclusion Criteria:

  • Previous radiation therapy to the ipsilateral breast
  • Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02272400

United States, New York
Laura and Isaac Perlmutter Cancer Center at NYU
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Silvia C Formenti, M.D. NYU Langone Medical Center
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02272400     History of Changes
Other Study ID Numbers: 07-582
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
image guided radiation therapy
partial breast irradiation
breast cancer
breast preservation