Status:
COMPLETED
Study of APN201 (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer
Lead Sponsor:
Apeiron Biologics
Conditions:
Radiation Induced Dermatitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The standard treatment for early-stage breast cancer is breast-conserving surgery followed by adjuvant radiation therapy to the whole breast. This approach leads to low recurrence rates with a good co...
Eligibility Criteria
Inclusion
- Women ≥ 18 years of age, with breast cancer, treated by breast conserving surgery and scheduled to receive adjuvant radiotherapy to the breast alone
- Bra cup size ≤D
- Karnofsky performance status of ≥ 80%
- Women of childbearing potential must have a negative pregnancy test before study entry and must agree to use a medically acceptable method of birth control throughout the study period
- Ability to understand and willingness to sign a written informed consent document
Exclusion
- Bilateral breast cancer
- Inflammatory breast cancer
- Lymphangiosis carcinomatosa
- Medically significant dermatologic conditions affecting the irradiated area
- Planned use of other agents with the aim of preventing and/or treating radiation dermatitis
- Concomitant medications which might exacerbate radiation dermatitis
- History of previous radiation therapy of the breast
- Pregnancy or breastfeeding
- Having received any other investigational agent within 4 weeks before enrolment
- Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01513278
Start Date
January 1 2012
End Date
May 1 2012
Last Update
July 15 2013
Active Locations (1)
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1
Medical University Graz; Department of Therapeutic Radiology and Oncology
Graz, Austria, Austria, 8036