Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)

NCT05269160 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: H-45698
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

Radiotherapy is a mainstay of treatment in breast cancer treatment, in the adjuvant setting. Radiation dermatitis occurs in up to 65% of these patients; currently, there is no standard of care for this treatment-related toxicity. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream (termed "Dermaprazole") in patients who require radiation for breast cancer in the adjuvant setting.

Conditions

Radiation Dermatitis; Breast Cancer

Keywords

Radiation dermatitis; post-mastectomy; radiation therapy; breast cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose-Limiting Toxicity(DLT) in Phase I

  A DLT is defined as any of the following:1) Any \> Grade 2 skin toxicity outside the radiation field (Macules/ papules covering 10-30% of the area with or without symptoms of pruritus, burning, tightness); 2). Any \> Grade 2 radiation dermatitis (Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema) within the treatment field that is probably or definitely related to Dermaprazole. Dermatitis will be evaluated by a radiation oncologist on a weekly basis using the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria. Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16.

  from the first day applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment, up to 13 weeks

• Rate of Clinically Bothersome Radiation Dermatitis at Maximum Feasible Dose in Phase II

  Radiation dermatitis will be determined by the radiation oncologist and defined using NCI Common Terminology Criteria for Adverse Events (CTCAE version 5) for dermatitis radiation. In particular, the individual components of radiation dermatitis will be recorded: erythema, desquamation, edema, bleeding, skin necrosis and skin ulceration.

  at weekly during radiation treatment, up to 7 weeks

Secondary Outcomes (5)

• Number of Participants With Grade 2 or Higher Acute Radiation Dermatitis

  from the first day the subject applies the cream to the end of the 6 month follow up period

• Median- Occurrence Time of Grade 2 or Higher Acute Radiation Dermatitis

  from the first day the subject applies the cream to the end of the 6 month follow up period

• Median-healing Time of Grade 2 or Higher Acute Radiation Dermatitis Develops

  from the first day the subject applies the cream to the end of the 6 month follow up period

• Median of the Peak Score of Total QOL Score

  at before and after Dermaprazole cream application at the CT simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy

• Number of Missed Radiation Treatments Due to Skin Toxicity

  at weekly during radiation treatment, up to 7 weeks

Study Arms (2)

Dermaprazole 1% (Breast)

EXPERIMENTAL

Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Drug: Dermaprazole 1%

Dermaprazole 2% (Breast)

EXPERIMENTAL

Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Drug: Dermaprazole 2%

Interventions

Dermaprazole 1% DRUG

Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks

Dermaprazole 1% (Breast)

Dermaprazole 2% DRUG

Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks

Dermaprazole 2% (Breast)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy
• Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)
• Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Written Informed Consent
• History and Physical within 12 weeks of enrollment

You may not qualify if:

• Prior chest wall radiotherapy
• Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
• Concurrent chemotherapy
• Biopsy-proven epidermal involvement or positive margins
• Open wound at time of consultation, or delayed surgical wound healing as defined as open wound \>8 weeks post-op
• Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis.
• Allergy or sensitivity to proton pump inhibitors
• Pregnancy or breast feeding
• Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Baylor St. Luke's Medical Center

Houston, Texas, 77054, United States

Location

Harris Health System - Smith Clinic

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Results Point of Contact

• Title: Eunji Jo, Study Statistician
• Organization: Baylor College of Medicine

ejo@bcm.edu

713-798-4923

Study Officials

• Daniel A Hamstra, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman/Professor

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 7, 2022
• Study Start: April 24, 2023
• Primary Completion: June 26, 2023
• Study Completion: April 15, 2024
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2025-07

Locations

US (2)