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A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer, Radiation Toxicity

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Trial Information

A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer


- 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.

Inclusion Criteria


- 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

- 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


- 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


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy

Outcome Description:

Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale

Outcome Time Frame:

during the first 5 years after treatment

Safety Issue:


Principal Investigator

Laurie W. Cuttino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

April 2013

Related Keywords:

  • Breast Cancer
  • Radiation Toxicity
  • radiation toxicity
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • breast cancer in situ
  • Breast Neoplasms
  • Radiation Injuries