Radiation Therapy Schedules for Breast Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen bySilvia C Formenti, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.

Eligibility Criteria

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.

Inclusion Criteria

My breast cancer was removed with clear margins.

My cancer has not spread to nearby lymph nodes.

I am a post-menopausal woman who has had part of my breast removed.

Exclusion Criteria

I have had radiation therapy on the same side breast before.

My biopsy shows a significant amount of DCIS, indicating extensive intraductal cancer.

Participant Groups

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.

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.