Trial Outcomes & Findings for Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer (NCT NCT00902668)

NCT ID: NCT00902668

Last Updated: 2013-06-20

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: during the first 5 years after treatment
• Results posted on: 2013-06-20

Participant Flow

Study was open to accrual from 4/21/09 to 3/2/10. Patients were recruited from radiation oncology clinics.

Patients can be registered only after pretreatment evaluation is completed and eligibility criteria are met. Protocol treatment begins on the first day of external beam radiation therapy or on the first day of brachytherapy and continues for 12 months.

Participant milestones

Measure	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.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

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.

Overall Study Protocol stopped due to slow accrual.

3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Supportive Care (Lovastatin) n=3 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	63 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: during the first 5 years after treatment

Population: Due to slow accrual the study was closed to accrual and all 3 participants were terminated. No data was analyzed.

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

Outcome measures

Outcome data not reported

Adverse Events

Supportive Care (Lovastatin)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Supportive Care (Lovastatin) n=3 participants at risk 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.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation	66.7% 2/3 • Number of events 2 • From Baseline to Off Study. 7 months or less
Skin and subcutaneous tissue disorders Hyperpigmentation	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Skin and subcutaneous tissue disorders Pruritus/itching	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Skin and subcutaneous tissue disorders Rash/desquamation	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
General disorders Fatigue (asthenia, lethargy, malaise)	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Gastrointestinal disorders Taste alteration (dysgeusia)	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
Infections and infestations Infection with unknown ANC - Vagina	33.3% 1/3 • Number of events 2 • From Baseline to Off Study. 7 months or less
Musculoskeletal and connective tissue disorders Fibrosis-cosmesis	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less
General disorders Pain - Breast	33.3% 1/3 • Number of events 2 • From Baseline to Off Study. 7 months or less
General disorders Pain - Extremity-limb	33.3% 1/3 • Number of events 1 • From Baseline to Off Study. 7 months or less

Additional Information

Laurie W. Cuttino, MD

Virginia Commonwealth University

Phone: 804-828-7232

Email: LCuttino@mcvh-vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place