Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically and/or cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer)
Scheduled to receive neoadjuvant/adjuvant HER2 targeted therapy
Between ≥18 years of age
Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy
Disqualifiers
Participants with stage IV breast cancer
Participants currently taking statins
Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
No active liver disease
Trial design
Design model
Single group
Treatments tested in this trial
Lipitor 40mg Tablet
DrugLIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Anti-HER2 targeted therapy + Lipitor 40mg dailyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With at Least One Adverse Event will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
Adverse events (AEs) will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
Time frame
Five yearsSecondary outcomes
1
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain
Quality of Life questionnaire using PROMIS will be administered at baseline, six, twelve and fifteen months
Time frame
Baseline, six, twelve and fifteen monthsOther outcomes
1
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure fatigue
Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months
Time frame
Baseline, six, twelve and fifteen months2
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure physical functioning
Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure physical functioning
Time frame
Baseline, six, twelve and fifteen months3
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure emotional distress
Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure emotional distress
Time frame
Baseline, six, twelve and fifteen months4
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure social participation
Quality of Life questionnaire using PROMIS will be administered at baseline six, twelve and fifteen months to measure social participation
Time frame
Baseline, six, twelve and fifteen monthsSponsors and contacts
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Source ClinicalTrials.gov