Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

NCT01380353 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: NU 10B05STU00042939
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Women undergoing total mastectomy; Breast cancer prevention

Outcome Measures

Primary Outcomes (1)

• Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen

  The primary objective of this protocol will demonstrate that diclofenac epolamine patch applied to the skin of the breast for three days (1, 2) prior to surgery will result in significantly higher drug concentrations in the breast than the same dose applied to the abdominal skin for the same duration of time.

  after 3 days of treatment prior to surgery

Secondary Outcomes (1)

• Determine how the concentrations of the study patch is distributed in the breast.

  after three days of treatment prior to surgery

Study Arms (2)

Breast Group

EXPERIMENTAL

Diclofenac epolamine patch applied to the breast

Drug: Diclofenac epolamine patch

Abdomen Group

EXPERIMENTAL

Diclofenac epolamine patch applied to the abdomen

Drug: Diclofenac epolamine patch

Interventions

Diclofenac epolamine patch DRUG

Patch (10cm X 14cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner \[B\].

Also known as: Flecto Patch

Abdomen Group; Breast Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seema Khan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: November 12, 2012
• Study Completion: November 12, 2012
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

US (1)