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

NCT00902668 | Terminated Phase 2 Results DMC

• 4 other identifiers: MCC-12044HM12044CDR0000642246NCI-2012-01188
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Radiation Toxicity

Keywords

radiation toxicity; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; breast cancer in situ

Outcome Measures

Primary Outcomes (1)

• 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

  during the first 5 years after treatment

Study Arms (1)

Supportive care (lovastatin)

EXPERIMENTAL

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

Interventions

lovastatin DRUG

Supportive care (lovastatin)

questionnaire administration OTHER

Supportive care (lovastatin)

adjuvant therapy PROCEDURE

Supportive care (lovastatin)

accelerated partial breast irradiation RADIATION

Supportive care (lovastatin)

external beam radiation therapy RADIATION

Supportive care (lovastatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries; Breast Carcinoma In Situ

Interventions

Lovastatin; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Limitations and Caveats

Early termination leading to no subjects analyzed.

Results Point of Contact

• Title: Laurie W. Cuttino, MD
• Organization: Virginia Commonwealth University

LCuttino@mcvh-vcu.edu

804-828-7232

Study Officials

• Laurie W. Cuttino, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2013
• Last Updated: June 20, 2013
• Results First Posted: May 30, 2013

Record last verified: 2013-05