Breast CancerPhase 2NCT00902668
Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer
A Phase 2 study testing lovastatin, questionnaire administration and adjuvant therapy in people with Breast Cancer and Radiation Toxicity, run by Virginia Commonwealth University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiation Toxicity
- What is being tested?
- lovastatin, questionnaire administration and adjuvant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Radiation Toxicity
- Being tested
- lovastatin, questionnaire administration, adjuvant therapy, accelerated partial breast irradiation, external beam radiation therapy
- Keywords
- radiation toxicity, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, breast cancer in situ
- Medical subject headings
- Breast Neoplasms, Radiation Injuries, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lovastatinDrug
questionnaire administrationOther
adjuvant therapyProcedure or surgery
accelerated partial breast irradiationRadiation
external beam radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: lovastatin; Other: questionnaire administration; Procedure: adjuvant therapy; Radiation: accelerated partial breast irradiation; Radiation: external beam radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the first 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionApr 2013
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie W. Cuttino, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902668
- Sponsor's protocol ID
- MCC-12044
- Other IDs
- HM12044, CDR0000642246, NCI-2012-01188
- Status last verified
- May 2013
- First submitted
- 14 May 2009
- Last updated
- 20 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT00902668
- Acronym / sponsor ID
- MCC-12044
- Conditions
- Breast Cancer, Radiation Toxicity
- Keywords
- radiation toxicity, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, breast cancer in situ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Posted 30 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (lovastatin) | Experimental | Drug: lovastatin, Other: questionnaire administration, Procedure: adjuvant therapy, Radiation: accelerated partial breast irradiation, Radiation: external beam radiation therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lovastatin | Drug | Supportive care (lovastatin) |
| questionnaire administration | Other | Supportive care (lovastatin) |
| adjuvant therapy | Procedure or surgery | Supportive care (lovastatin) |
| accelerated partial breast irradiation | Radiation | Supportive care (lovastatin) |
| external beam radiation therapy | Radiation | Supportive care (lovastatin) |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie W. Cuttino, MD principal investigator
Massey Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lovastatin, questionnaire administration and adjuvant therapy in people with Breast Cancer and Radiation Toxicity, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.