Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	NCCTG-N06C4 NCT00438659, N06C4

Objectives

Primary

1. Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

Secondary

1. Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs.
2. Compare the time to onset and duration of severe radiation dermatitis in these patients.
3. Assess skin toxicity and quality of life of these patients.
4. Assess the adverse event profile of mometasone furoate in these patients.
5. Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs.

Entry Criteria

Disease Characteristics:

• Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ



• Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:
  • Whole breast (as part of breast-conservation therapy)
  • Chest wall (as part of post-mastectomy irradiation)
    • Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed



• Must meet the following criteria for planned radiotherapy:
  • Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy
  • No planned split-course radiotherapy
  • No partial breast treatment, defined as treatment of < 75% of the breast parenchyma
  • Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed



• Must be entered on study within 7 days prior to beginning radiotherapy
  • Must start study drug prior to receiving the third radiotherapy fraction



• No preexisting skin breakdown within the planned radiotherapy field at the time of study entry



• No bilateral breast cancer treatment



• No inflammatory carcinoma of the breast



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior radiotherapy to the planned radiotherapy treatment area
• No concurrent or planned leukotriene inhibitors, including the following:
  • Zafirleukast
  • Monteleukast
  • Zileuton
• No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:
  • Cortaid®
  • Cortizone 10®
  • Tucks®
  • Preparation H®
• No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment

Patient Characteristics:

• Male or female
• Menopausal status not specified
• ECOG performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to complete questionnaires independently or with assistance
• No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde

Expected Enrollment

A total of 148 patients will be accrued for this study.

Outcomes

Maximum grade of radiation dermatitis as measured by NCI CTCAE v3.0

Incidence of severe (grade ≥ 3) radiation dermatitis
Time to onset of severe radiation dermatitis
Duration of severe radiation dermatitis
Overall quality of life (QOL) as measured by Linear Analogue Self-Assessment (LASA)
QOL domains as measured by LASA
Skin toxicity as measured by Skindex-16
Skin toxicity as measured by the Skin Toxicity Assessment Tool
Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and assessed clinically by NCI CTCAE v3.0

Outline

This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to radiation field (breast [post-lumpectomy] vs chest wall [post-mastectomy]), regional lymph nodes (treated vs not treated), and planned total radiation dose (including boost) (50-55 Gy vs > 55 Gy). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.



• Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in arm I.

Patients complete questionnaires and a symptom experience diary at baseline and periodically during study for quality of life, skin toxicity, and adverse event assessment.

After completion of radiotherapy, patients are followed for 2 weeks.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Robert Miller, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Patricia Griffin, MD, Protocol co-chair		Ph: 864-560-6917 Email: pgriffin@srhs.com
James Martenson, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Phase III Randomized Double-Blind Study of Mometasone Furoate versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy
Trial Start Date		2007-08-17
Registered in ClinicalTrials.gov		NCT00438659
Date Submitted to PDQ		2007-01-09
Information Last Verified		2009-01-06
NCI Grant/Contract Number		CA374040

Back to Top