Cardiac ToxicityPhase 2NCT05559164
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
A Phase 2 study testing Lipitor 40mg Tablet in people with Cardiac Toxicity and Early-stage Breast Cancer, run by Rutgers, The State University of New Jersey at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiac Toxicity, Early-stage Breast Cancer
- What is being tested?
- Lipitor 40mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Sep 2022to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
- Baseline LVEF ≥ 50%
- Prior cancers allowed if no evidence of disease in last 5 years
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- ECOG 0-2
- No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy
- Adequate bone marrow function:
- ANC ≥ 1000/uL II. platelet count ≥ 100,000/uL III. hemoglobin ≥ 9.0 g/dL
- Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III. ALT (SGPT) ≤ 5 X ULN
- Adequate renal function, Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
- Ability to understand the nature of this study protocol and give written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Who cannot join
- 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
- Current use of CYP 3A4 inhibitors
- Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
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- Life expectancy < 12 weeks
- Pregnancy (positive pregnancy test) or lactation
- Pre-existing sensory neuropathy > grade one
- Has significant cardiovascular disease, such as:
- LVEF < 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardial disease as described by the New York Heart Association ii) Recent history (within 6 months prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time of randomization
- Major surgery without complete recovery in the past four weeks prior to screening
- Concurrent active infection
- Participant with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C
- Participant who has a history of allergy or hypersensitivity to any of the study drugs
- Participant with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202
Mridula George, MD, 732-235-9081, mridula@cinj.rutgers.edu
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690
Mridula George, MD, 732-235-2465, mridula@cinj.rutgers.edu
- Recruiting
RWJBarnabas Health - - Jersey City Medical Medical
Jersey City, New Jersey, 07097
mridula George, MD, 732-235-9081, mridula@cinj.rutgers.edu
- Recruiting
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Mridula George, MD, 732-235-9081, mridula@cinj.rutgers.edu
- Recruiting
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
Mridula George, MD, 732 -235-9081, mridula@cinj.rutgers.edu
- Recruiting
Monmouth Community Medical
Long Branch, New Jersey, 07764
Mridula George, MD, 732-222-6046, mridula@CINJ.rutgers.edu
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Mridula George, MD, 732-235-9081, mridula@cinj.rutgers.edu
- Not yet recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Mridula George, MD, 732-235-9081, mridula@cinj.rutgers.edu
- Recruiting
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Mridula George, MD, 732-235-2465, mridula@cinj.rutgers.edu
- Recruiting
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08873
Mridula George, MD, 732-235-2465, mridula@cinj.rutgers.edu
About this study
Official title: STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
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.
Read the detailed description
A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy. This study will evaluate the hypothesis that addition of statins will reduce treatment delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in patients being treated with anti-HER2 therapy. The long-term goal of this study is to improve disease related outcomes and quality of life measures in patients being treated with anti-HER2 therapy.
- Conditions
- Cardiac Toxicity, Early-stage Breast Cancer
- Being tested
- Lipitor 40mg Tablet
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipitor 40mg TabletDrug
Also called Atorvastatin Calcium
LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food
| Study group | Role | What they receive |
|---|---|---|
| Anti-HER2 targeted therapy + Lipitor 40mg daily | Experimental | Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy. Receives: Drug: Lipitor 40mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Five years
Secondary 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
Measured: Baseline, six, twelve and fifteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start19 Sep 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ToxicityStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stage I-III HER2positive breast cancer receiving anti-HER2 therapy. Participants will receive Lipitor 40 mg PO daily. Anti-HER2 targeted therapy + Lipitor 40mg daily
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mridula George, MD, Rutgers, The State University of New Jersey
- Investigators
- Mridula George, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559164
- Sponsor's protocol ID
- 042201
- Other IDs
- Pro2022000290
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2022
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
- ClinicalTrials.gov ID
- NCT05559164
- Acronym / sponsor ID
- 042201
- Conditions
- Cardiac Toxicity, Early-stage Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy. This study will evaluate the hypothesis that addition of statins will reduce treatment delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in patients being treated with anti-HER2 therapy. The long-term goal of this study is to improve disease related outcomes and quality of life measures in patients being treated with anti-HER2 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stage I-III HER2positive breast cancer receiving anti-HER2 therapy. Participants will receive Lipitor 40 mg PO daily. Anti-HER2 targeted therapy + Lipitor 40mg daily
| Arm | Type | Receives |
|---|---|---|
| Anti-HER2 targeted therapy + Lipitor 40mg daily | Experimental | Drug: Lipitor 40mg TabletParticipants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Baseline LVEF ≥ 50%
Key exclusion criteria (17 listed)
- 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
- Current use of CYP 3A4 inhibitors
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 |
|---|---|---|
| Lipitor 40mg TabletAlso: Atorvastatin CalciumLIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food | Drug | Anti-HER2 targeted therapy + Lipitor 40mg daily |
Primary outcome
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
Time frame: Five years
Adverse events (AEs) will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
1 secondary outcome
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain
Time frame: Baseline, six, twelve and fifteen months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Mridula George, MD principal investigator
Rutgers Cancer Institute of New Jersey
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipitor 40mg Tablet in people with Cardiac Toxicity and Early-stage Breast Cancer, run by Rutgers, The State University of New Jersey at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mridula George, MD (732-235-9081, mridula@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Five years). 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 14 Nov 2025.