Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00902668
• Other study ID #: MCC-12044
• Secondary ID: HM12044CDR000064
• Status: Terminated
• Phase: Phase 2
• First received: May 14, 2009
• Last updated: June 11, 2013
• Start date: April 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs, such as lovastatin, may protect normal cells from the side effects of radiation therapy.

PURPOSE: This phase II trial is studying how well lovastatin works in reducing side effects after radiation therapy in women with breast cancer.

Description:

OBJECTIVES:

• To determine the incidence of good/excellent cosmetic outcome, as defined by the Harvard Scale, after radiotherapy in women treated with lovastatin, as compared to historical controls.

OUTLINE: Patients undergo standard external beam whole-breast irradiation and/or accelerated partial breast irradiation. Patients receive oral lovastatin once daily beginning on the first day of radiotherapy and continuing for 12 months in the absence of disease progression or unacceptable toxicity.

Patients complete a questionnaire, the Breast Cancer Treatment Outcome Scale, at baseline and then at 6 months, 12 months, and 3 years after completion of radiotherapy to assess cosmetic and functional outcomes.

After completion of radiotherapy, patients are followed periodically for up to 5 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of invasive or in situ epithelial cancer of the breast

• Stage 0, I, or II (Tis, T1, or T2) disease

• Unifocal disease (single focus that can be encompassed by breast-conserving surgery)

• Has undergone prior surgical resection of the primary lesion (lumpectomy) and axillary nodal evaluation (if invasive disease is present)

• Negative surgical margins (= 1 mm)

• Planning to undergo radiotherapy with either standard external beam radiotherapy or accelerated partial breast irradiation (interstitial or balloon brachytherapy)

• No Paget disease of the nipple

• No evidence of distant metastases

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• Karnofsky performance status 70-100%

• Transaminases < 3 times upper limit of normal (ULN)

• Creatine kinase < 5 times ULN

• Creatinine clearance = 30 mL/min

• Negative pregnancy test

• No active liver or muscle disease

• No history of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)

• History of prior malignancy allowed provided life expectancy is = 4 years

• No major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of study treatment or interfere with follow-up

• No contraindication to an HMG-coA-reductase inhibitor

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior radiotherapy to the breast, lung, or mediastinum

• Prior radiotherapy to the contralateral breast allowed

• No chemotherapy for = 2 weeks prior to, during, and for = 2 weeks after completion of radiotherapy

• No concurrent cytochrome P450 3A4 inhibitors

• Concurrent HMG-coA-reductase inhibitor allowed provided patient is able to switch to 20 mg of lovastatin per day

• Concurrent tamoxifen or an aromatase inhibitor allowed

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiation Injuries
• Radiation Toxicity

Intervention

Drug:
• lovastatin

Other:
• questionnaire administration

Procedure:
• adjuvant therapy

Radiation:
• accelerated partial breast irradiation

• external beam radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy	Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale	during the first 5 years after treatment	No