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

NCT ID: NCT00902668

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-04-30

Brief 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.

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.

Conditions

Breast Cancer; Radiation Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

lovastatin

Intervention Type: DRUG

questionnaire administration

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

accelerated partial breast irradiation

Intervention Type: RADIATION

external beam radiation therapy

Intervention Type: RADIATION

Interventions

lovastatin

Intervention Type: DRUG

questionnaire administration

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

accelerated partial breast irradiation

Intervention Type: RADIATION

external beam radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie W. Cuttino, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Other Identifiers

HM12044

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000642246

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-01188

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-12044

Identifier Type: -

Identifier Source: org_study_id