Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer
A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Supportive care (lovastatin)
Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days.
Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy
Time Frame: during the first 5 years after treatment
|
Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale
|
during the first 5 years after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurie W. Cuttino, MD, Massey Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Lovastatin
- L 647318
- Dihydromevinolin
Other Study ID Numbers
- MCC-12044
- HM12044 (OTHER: VCU IRB)
- CDR0000642246 (REGISTRY: PDQ (Physician Data Query))
- NCI-2012-01188 (REGISTRY: CTRP (Clinical Trials Reporting System))
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