← Back to Search

Radiation Therapy Schedules for Breast Cancer

Phase 2
Waitlist Available
Led By Silvia C Formenti, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage 1 (pT1) breast cancer, excised with negative margins
Clinically N0 or No Regional Lymph node (pN0) or sentinel node negative
Must not have
Previous radiation therapy to the ipsilateral breast
Presence of a proportion of Ductal Carcinoma in-situ (DCIS) in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a higher dose of radiation given over a shorter period of time is just as effective as a lower dose given over a longer period of time in treating early stage breast cancer.

Who is the study for?
This trial is for post-menopausal women who have had a segmental mastectomy for Stage 1 breast cancer with negative margins and no lymph node involvement. Candidates must not have had previous radiation to the affected breast or a high proportion of DCIS indicative of EIC in their biopsy.
What is being tested?
The study compares two radiation treatments for breast cancer: one group receives 600 cGy over five days, while the other gets 800 cGy every other day, completing treatment within a week. Patients will be monitored regularly up to ten years after treatment.
What are the potential side effects?
Potential side effects include skin changes, fatigue, swelling in the treated area (lymphedema), and possible long-term tissue scarring known as fibrosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer was removed with clear margins.
Select...
My cancer has not spread to nearby lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation therapy on the same side breast before.
Select...
My biopsy shows a significant amount of DCIS, indicating extensive intraductal cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with grade 2 or 3 fibrosis between the two treatment groups will be compared.
Secondary study objectives
Recurrence rates will be documented

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 - 800 cGY x 3 fractionsExperimental Treatment1 Intervention
Patients will receive 800 cGY x 3 fractions of radiation therapy every other day for 3 days.
Group II: Arm 1 - 600 cGY x 5 fractionsExperimental Treatment1 Intervention
Patients will receive 600 cGY x 5 fractions of radiation therapy over 5 consecutive days.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,085 Previous Clinical Trials
1,146,972 Total Patients Enrolled
29 Trials studying Breast Cancer
27,087 Patients Enrolled for Breast Cancer
Silvia C Formenti, M.D.Principal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Breast Cancer
44 Patients Enrolled for Breast Cancer

Media Library

Arm 1 600 cGY x 5 fractions Clinical Trial Eligibility Overview. Trial Name: NCT02755896 — Phase 2
Breast Cancer Research Study Groups: Arm 1 - 600 cGY x 5 fractions, Arm 2 - 800 cGY x 3 fractions
Breast Cancer Clinical Trial 2023: Arm 1 600 cGY x 5 fractions Highlights & Side Effects. Trial Name: NCT02755896 — Phase 2
Arm 1 600 cGY x 5 fractions 2023 Treatment Timeline for Medical Study. Trial Name: NCT02755896 — Phase 2
~0 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top