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

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902668
First Posted: May 15, 2009
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose

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.


Condition Intervention Phase
Breast Cancer Radiation Toxicity Drug: lovastatin Other: questionnaire administration Procedure: adjuvant therapy Radiation: accelerated partial breast irradiation Radiation: external beam radiation therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy [ Time Frame: during the first 5 years after treatment ]
    Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale


Enrollment: 3
Study Start Date: April 2009
Study Completion Date: April 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: lovastatin Other: questionnaire administration Procedure: adjuvant therapy Radiation: accelerated partial breast irradiation Radiation: external beam radiation therapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902668


Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Laurie W. Cuttino, MD Massey Cancer Center
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00902668     History of Changes
Other Study ID Numbers: MCC-12044
HM12044 ( Other Identifier: VCU IRB )
CDR0000642246 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-01188 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: May 14, 2009
First Posted: May 15, 2009
Results First Submitted: April 11, 2013
Results First Posted: May 30, 2013
Last Update Posted: June 20, 2013
Last Verified: May 2013

Keywords provided by Virginia Commonwealth University:
radiation toxicity
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
breast cancer in situ

Additional relevant MeSH terms:
Breast Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Wounds and Injuries
Lovastatin
L 647318
Dihydromevinolin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors