Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

Completed · Early Phase 1

Conditions studied: Breast Cancer

In brief

The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast. The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.

Key facts

Study ID

NCT01380353

Run by

Northwestern University

People needed

30

Starts

2011-06-01

Expected to finish

2012-11-12

Last updated by the study team

2020-02-19

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women between the ages of 18 and 80 years, undergoing total mastectomy for, with or without axillary surgery for diagnosis or prevention of breast cancer.
• ECOG performance status less than 2.
• Ability to understand and the willingness to sign a written informed consent.
• Participants must have normal organ and marrow function

You may not qualify if…

• Prior history of ipsilateral breast radiotherapy.
• Pregnant women and those who will be actively breast-feeding in the preoperative period will be excluded.
• Inability to discontinue aspirin or warfarin use during the period of participation.
• Known allergy to diclofenac epolamine, or aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID).
• Renal failure

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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