Clinical trial NCT00902668: Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer
Official title: A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Radiation Toxicity
Keywords: radiation toxicity
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
breast cancer in situ
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy
timeFrame: during the first 5 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massey Cancer Center
name: Laurie W. Cuttino, MD
role: PRINCIPAL_INVESTIGATOR
References: