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Phase III Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase III Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor


Arm 1 is a concomitant boost protocol over three weeks which has previously been evaluated
in over 500 patients (NYU 03-30 and NYU 05-181) and has shown excellent tolerance, and
results. Arm 2 evaluates a Weekend Boost Dose (WBD) regimen which may have a
radiobiological advantage by counteracting tumor repopulation which can occur over the
weekend break. At the time of registration in the study, patients will be randomized to
either treatment arm and stratified according to pre or post-menopausal status and on
previous chemotherapy received or not.


Inclusion Criteria:



- Pre or post-menopausal women with stage 0,I, and II breast cancer

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

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

- At least 2 weeks from last chemotherapy

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

Exclusion Criteria:

- Previous radiation therapy to the ipsilateral breast

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

- Active connective tissue disorders, such as lupus or scleroderma

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

- Pregnant or lactating women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute radiation toxicities recorded according to RTOG

Outcome Time Frame:

Day 1 of radiation treatment to day 60

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

09-0030

NCT ID:

NCT01000662

Start Date:

March 2009

Completion Date:

March 2022

Related Keywords:

  • Breast Cancer
  • whole breast radiotherapy
  • tumor bed boost
  • Breast Neoplasms

Name

Location
Bellevue Hospital Center New York, New York  10016
NYU Clinical Cancer Center New York, New York  10016
Tisch Hospital New York, New York  10016