Breast Cancer, Radiation Toxicity
Conditions
Keywords
radiation toxicity, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, breast cancer in situ
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.
Interventions
DRUGlovastatin
OTHERquestionnaire administration
PROCEDUREadjuvant therapy
RADIATIONaccelerated partial breast irradiation
RADIATIONexternal beam radiation therapy
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy | during the first 5 years after treatment | Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale |
Participant flow
Recruitment details
Study was open to accrual from 4/21/09 to 3/2/10. Patients were recruited from radiation oncology clinics.
Pre-assignment details
Patients can be registered only after pretreatment evaluation is completed and eligibility criteria are met. Protocol treatment begins on the first day of external beam radiation therapy or on the first day of brachytherapy and continues for 12 months.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol stopped due to slow accrual. | 3 |
Baseline characteristics
| Characteristic | Supportive Care (Lovastatin) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age Continuous | 63 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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
Time frame: during the first 5 years after treatment
Population: Due to slow accrual the study was closed to accrual and all 3 participants were terminated. No data was analyzed.