Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer

Key facts

Study ID

NCT02883985

Run by

NYU Langone Health

People needed

100

Starts

2000-05-01

Expected to finish

2017-09-01

Last updated by the study team

2018-12-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Post-menopausal women (at least 2 years without menstrual period):
• hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.
• Original tumor non-palpable (mammographically detected).
• Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
• N0 or sentinel node negative or N0 clinically if the tumor is <1 cm in size.
• Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined.
• Prescribed antihormonal therapy as part of their management.

You may not qualify if…

• Previous radiation therapy to the ipsilateral breast.
• Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
• Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
• Women with a diagnosis of multifocal breast cancer.

Where it is running

• NYU Perlmutter Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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