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Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

During the past ten years the Breast Cancer Radiotherapy Research team at NYU has conducted
a series of consecutive studies to optimize the safe delivery of accelerated radiotherapy to
partial and whole breast in the prone position, as summarized in a recent review of this
experience. The current protocol focuses on whole breast radiotherapy for women with stage
0-2 breast cancer treated by segmental mastectomy: it aims at further refining the role of
prone IMRT versus a 3D-conformal radiotherapy technique in this common subset of patients.

This study is an open label randomized trial. Patients will be randomized within cohort
defined by assigned treatment (3D CRT if IMRT not covered or IMRT) and within these primary
strata by menopausal status (pre/post) and by chemotherapy prior to radiation (yes/no). The
on-site treatment randomization assignments will done on site and treatment assignments will
be provided to the Research Nurse after she has confirmed eligibility. Patients will be
randomized within the primary strata based on presumed insurance coverage on consent to the
study to allow simulation to proceed. Should the coverage change, then the patient will be
re-randomized in the correct stratum and the initial randomization number will be retired
with a notation that the initial stratification was revised and patient re-randomized.

Patients will have completed all breast surgical procedures prior to accrual into this
protocol in order to establish eligibility criteria. Final pathology margins must be at
least 1 mm in all directions to be eligible. The patient may undergo re-excision if the
initial margins are involved or close (< 1mm). If the patient meets the eligibility criteria
after re-excision, she may be entered onto the study.

Inclusion Criteria:

1. Pre- or post-menopausal women with Stage 0, I and II breast cancer (Post-menopausal
women defined as either (a) at least 2 years without menstrual period or (b) or
patients older than 50 with serological evidence of post-menopausal status or (c)
hysterectomized patients of any age with FSH confirmation of post-menopausal status)

2. Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm

3. Status post segmental mastectomy, after sentinel node biopsy and/or axillary node
dissection (DCIS and Tumors <5 mm in size do not require nodal assessment)

4. At least 2 weeks from last chemotherapy

5. Patient needs to be able to understand and demonstrate willingness to sign a written
informed consent document

Exclusion Criteria:

1. Previous radiation therapy to the ipsilateral breast

2. More than 3 involved nodes identified at axillary staging, requiring adjuvant
axillary radiation

3. Active connective tissue disorders, such as lupus or scleroderma

4. Prior or concurrent malignancy other than basal or squamous cell skin cancer or
carcinoma in-situ of the cervix, unless disease-free > 3 years

5. Pregnant or lactating women

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with acute radiation toxicity of Grade 2 or higher.

Outcome Description:

By accruing 1000 patients randomized in strata defined by the two approaches to either weekly or daily boost, we will be able to establish the feasibility using different techniques and toxicity of prone breast radiotherapy with a weekly versus a daily boost, with IMRT and with 3DCRT non-IMRT approaches.

Outcome Time Frame:

Up to 90 days of radiation treatment

Safety Issue:


Principal Investigator

Silvia C. Formenti, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU Cancer Institute Department Radiation Oncology


United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

April 2017

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



NYU Cancer Institute New York, New York  10016