Clinical trial · Interventional
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
NCT00902668CI-TRIAL-00010894terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| accelerated partial breast irradiation | Radiation | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| lovastatin | Drug | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (lovastatin)
- description
- 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.
- interventionNames
- Drug: lovastatin
- Other: questionnaire administration
- Procedure: adjuvant therapy
- Radiation: accelerated partial breast irradiation
- Radiation: external beam radiation therapy
Primary outcomes (1)
- measure
- Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy
- timeFrame
- during the first 5 years after treatment
- description
- Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.