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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00902668
First received: May 14, 2009
Last updated: June 11, 2013
Last verified: May 2013

May 14, 2009
June 11, 2013
April 2009
April 2011   (final data collection date for primary outcome measure)
Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy [ Time Frame: during the first 5 years after treatment ] [ Designated as safety issue: No ]
Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale
Proportion of good/excellent cosmetic outcome during the first 5 years after radiotherapy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00902668 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Radiation Toxicity
  • Drug: lovastatin
  • Other: questionnaire administration
  • Procedure: adjuvant therapy
  • Radiation: accelerated partial breast irradiation
  • Radiation: external beam radiation therapy
Experimental: 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.
Interventions:
  • Drug: lovastatin
  • Other: questionnaire administration
  • Procedure: adjuvant therapy
  • Radiation: accelerated partial breast irradiation
  • Radiation: external beam radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
April 2013
April 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00902668
MCC-12044, HM12044, CDR0000642246, NCI-2012-01188
Yes
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Laurie W. Cuttino, MD Massey Cancer Center
Virginia Commonwealth University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP