HER2 Positive Breast CancerPhase 2SAFE-HEaRtNCT01904903
Cardiac Safety Study in Patients With HER2 + Breast Cancer
A Phase 2 study testing Trastuzumab, Pertuzumab and Ado Trastuzumab Emtansine in people with HER2 Positive Breast Cancer and Left Ventricular Function Systolic Dysfunction, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- HER2 Positive Breast Cancer, Left Ventricular Function Systolic Dysfunction
- What is being tested?
- Trastuzumab, Pertuzumab and Ado Trastuzumab Emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Jun 2020
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patient diagnosed with stage I-IV breast cancer
- HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) ≥ 2.0 on breast specimen or biopsy of a metastatic site
- LVEF < 50% and ≥ 40% documented in echocardiogram done within the last 30 days
- HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy
- Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation
- Age ≥ 18 years
- Patient is willing and able to comply with protocol required assessments and procedures
Who cannot join
- Previous hospitalization due to documented heart failure in the last 12 months
- Current signs or symptoms of heart failure or ischemia
- History of arrhythmia requiring pharmacological or electrical treatment
- Concomitant use of anthracyclines or use of anthracyclines in the last 50 days
- Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.
- History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
Official title: SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were developed, patients with HER2 positive breast cancer had a very aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine, patients are able to live longer and have better control of their cancer.
Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function.
Read more
In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed "picture" of the heart. We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not. The study will take a maximum of 12 months and patients will be monitored for 6 additional months.
We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on appropriate heart medications.
Read the detailed description
Title: A pilot study evaluating the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular function Phase: Pilot study Study Duration: 4 years with up to 5 additional years of follow up Study Center(s): 3 centers will be participating: MedStar Washington Hospital Center (MWHC), MedStar Georgetown University Hospital (MGUH) and Memorial Sloan Kettering Cancer Center (MSKCC) Primary Objective: To evaluate the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular ejection fraction (LVEF) when given concomitantly with cardiac treatment.
Secondary Objectives:
- To evaluate time to development of cardiac event or asymptomatic worsening of cardiac function
- Absolute changes in LVEF
- Delays in HER2 therapy attributed to cardiac causes
- Correlations between echocardiographic myocardial strain
- cTnI and hs-cTnT at baseline and over time with cardiac events and asymptomatic worsening of cardiac function Sample size: 30 patients
Diagnosis and Main Inclusion Criteria:
- HER2 positive breast cancer, stage I-IV.
- Mildly decreased cardiac function (LVEF between 40 and 49%) prior to or while receiving non-lapatinib HER2 targeted therapy
Cardiac Intervention:
- Beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses
Oncology study Products, Doses, Routes, Regimens:
- Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.
- Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.
- Ado-trastuzumab emtansine: 3.6mg/kg IV every three weeks. Note: both trastuzumab and pertuzumab may be administered alone or in combination with other systemic or radiation therapy.
Duration of drug administration: Maximum of 12 months.
- Being tested
- Trastuzumab, Pertuzumab, Ado Trastuzumab Emtansine
- Keywords
- Breast Cancer HER2 Positive, Cardiac Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herceptin
HER2 therapy
PertuzumabDrug
Also called Perjeta
HER2 therapy
Ado Trastuzumab EmtansineDrug
Also called Kadcyla
HER2 therapy
| Study group | Role | What they receive |
|---|---|---|
| HER2 therapies, cardiac medications | Other | Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses
Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:
* Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.
* Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.
* Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks. Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Ado Trastuzumab Emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function.
Cardiac events are defined as any of the following:
- Presence of symptoms attributable to heart failure as confirmed by a cardiologist
- Cardiac arrhythmia requiring pharmacological or electrical treatment
- Myocardial infarction
- Sudden cardiac death or death due to myocardial infarct, arrhythmia or heart failure
Asymptomatic worsening of cardiac function defined as:
- Asymptomatic decline in LVEF > 10% points from baseline and/or EF < 35% corroborated by a confirmatory echocardiogram in 2-4 weeks
Planned oncologic therapy is defined as:
- In the adjuvant setting: completion of 1 year total of HER2 targeted therapy. If a patient already received part of the planned HER2 targeted therapy prior to enrollment in this trial, planned oncologic therapy will be achieved when a total of 1 year is completed.
- In the metastatic setting: cessation of treating regimen due to progressive disease or non-cardiac toxicity or non-cardiac death.
Measured: Up to 18 months.
Secondary outcomes (5)
Median Time to Development of an Event Defined as Cardiac Event or Asymptomatic Worsening of Left Ventricular Dysfunction, Among Patients Who Developed One Event.
Measured: Up to 18 months.
Absolute Changes in LVEF During HER2 Targeted Therapy Between Baseline and End of Treatment
Difference in LVEF between end of treatment and baseline
Measured: Up to 18 months.
HER2 Therapy Holds Attributed to Proportion of Patients With Symptomatic or Asymptomatic Cardiotoxicity.
Proportion of patients that had a hold because of symptomatic or asymptomatic cardiotoxicity.
Hold is defined as any delay or discontinuation of HER2 targeted therapy due to cardiac toxicity. One cycle of HER2 targeted therapy will be considered 3 weeks. One therapy hold will be defined as any 3-week HER2 targeted therapy missed dose or 1/3 if one weekly trastuzumab dose. For patients who had a hold and resumed HER2 targeted therapy, duration of treatment hold will be described.
Measured: Up to 12 months.
Correlation of Global Longitudinal Myocardial Strain With Cardiac Events and Asymptomatic Worsening of Cardiac Function
Measured: Up to 18 months.
Correlation of Standard Cardiac Troponin I and Highly Sensitive Cardiac Troponin T With Cardiac Events and Asymptomatic Worsening of Cardiac Function
Measured: Up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2019
- Study completionJun 2020
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive Breast CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Sandra M Swain, MD, Principal investigator, Washington Cancer Institute at MedStar Washington Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904903
- Sponsor's protocol ID
- ML 28685
- Acronym
- SAFE-HEaRt
- Status last verified
- May 2022
- First submitted
- 17 Jul 2013
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lynce F, Barac A, Geng X, Dang C, Yu AF, Smith KL, Gallagher C, Pohlmann PR, Nunes R, Herbolsheimer P, Warren R, Srichai MB, Hofmeyer M, Cunningham A, Timothee P, Asch FM, Shajahan-Haq A, Tan MT, Isaacs C, Swain SM. Prospective evaluation of the cardiac safety of HER2-targeted therapies in patients with HER2-positive breast cancer and compromised heart function: the SAFE-HEaRt study. Breast Cancer Res Treat. 2019 Jun;175(3):595-603. doi: 10.1007/s10549-019-05191-2. Epub 2019 Mar 9.
PubMed 30852761Lynce F, Barac A, Tan MT, Asch FM, Smith KL, Dang C, Isaacs C, Swain SM. SAFE-HEaRt: Rationale and Design of a Pilot Study Investigating Cardiac Safety of HER2 Targeted Therapy in Patients with HER2-Positive Breast Cancer and Reduced Left Ventricular Function. Oncologist. 2017 May;22(5):518-525. doi: 10.1634/theoncologist.2016-0412. Epub 2017 Mar 17.
PubMed 28314836
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function
- ClinicalTrials.gov ID
- NCT01904903
- Acronym / sponsor ID
- SAFE-HEaRt / ML 28685
- Keywords
- Breast Cancer HER2 Positive, Cardiac Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were developed, patients with HER2 positive breast cancer had a very aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine, patients are able to live longer and have better control of their cancer.
Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function.
In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed "picture" of the heart. We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not. The study will take a maximum of 12 months and patients will be monitored for 6 additional months.
We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on appropriate heart medications.
Detailed description
Title: A pilot study evaluating the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular function Phase: Pilot study Study Duration: 4 years with up to 5 additional years of follow up Study Center(s): 3 centers will be participating: MedStar Washington Hospital Center (MWHC), MedStar Georgetown University Hospital (MGUH) and Memorial Sloan Kettering Cancer Center (MSKCC) Primary Objective: To evaluate the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular ejection fraction (LVEF) when given concomitantly with cardiac treatment.
Secondary Objectives:
- To evaluate time to development of cardiac event or asymptomatic worsening of cardiac function
- Absolute changes in LVEF
- Delays in HER2 therapy attributed to cardiac causes
- Correlations between echocardiographic myocardial strain
- cTnI and hs-cTnT at baseline and over time with cardiac events and asymptomatic worsening of cardiac function Sample size: 30 patients
Diagnosis and Main Inclusion Criteria:
- HER2 positive breast cancer, stage I-IV.
- Mildly decreased cardiac function (LVEF between 40 and 49%) prior to or while receiving non-lapatinib HER2 targeted therapy
Cardiac Intervention:
- Beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses
Oncology study Products, Doses, Routes, Regimens:
- Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.
- Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.
- Ado-trastuzumab emtansine: 3.6mg/kg IV every three weeks. Note: both trastuzumab and pertuzumab may be administered alone or in combination with other systemic or radiation therapy.
Duration of drug administration: Maximum of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 therapies, cardiac medications | Other | Drug: Trastuzumab, Drug: Pertuzumab, Drug: Ado Trastuzumab EmtansineCardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist: * Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week. * Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab. * Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female or male patient diagnosed with stage I-IV breast cancer
- HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) ≥ 2.0 on breast specimen or biopsy of a metastatic site
- LVEF < 50% and ≥ 40% documented in echocardiogram done within the last 30 days
- HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy
- Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation
Key exclusion criteria (6 listed)
- Previous hospitalization due to documented heart failure in the last 12 months
- Current signs or symptoms of heart failure or ischemia
- History of arrhythmia requiring pharmacological or electrical treatment
- Concomitant use of anthracyclines or use of anthracyclines in the last 50 days
- Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.
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 |
|---|---|---|
| TrastuzumabAlso: HerceptinHER2 therapy | Drug | HER2 therapies, cardiac medications |
| PertuzumabAlso: PerjetaHER2 therapy | Drug | HER2 therapies, cardiac medications |
| Ado Trastuzumab EmtansineAlso: KadcylaHER2 therapy | Drug | HER2 therapies, cardiac medications |
Primary outcome
Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function.
Time frame: Up to 18 months.
Cardiac events are defined as any of the following: * Presence of symptoms attributable to heart failure as confirmed by a cardiologist * Cardiac arrhythmia requiring pharmacological or electrical treatment * Myocardial infarction * Sudden cardiac death or death due to myocardial infarct, arrhythmia or heart failure Asymptomatic worsening of cardiac function defined as: - Asymptomatic decline in LVEF > 10% points from baseline and/or EF < 35% corroborated by a confirmatory echocardiogram in 2-4 weeks Planned oncologic therapy is defined as: * In the adjuvant setting: completion of 1 year total of HER2 targeted therapy. If a patient already received part of the planned HER2 targeted therapy prior to enrollment in this trial, planned oncologic therapy will be achieved when a total of 1 year is completed. * In the metastatic setting: cessation of treating regimen due to progressive disease or non-cardiac toxicity or non-cardiac death.
5 secondary outcomes
Median Time to Development of an Event Defined as Cardiac Event or Asymptomatic Worsening of Left Ventricular Dysfunction, Among Patients Who Developed One Event.
Time frame: Up to 18 months.
Absolute Changes in LVEF During HER2 Targeted Therapy Between Baseline and End of Treatment
Time frame: Up to 18 months.
HER2 Therapy Holds Attributed to Proportion of Patients With Symptomatic or Asymptomatic Cardiotoxicity.
Time frame: Up to 12 months.
Correlation of Global Longitudinal Myocardial Strain With Cardiac Events and Asymptomatic Worsening of Cardiac Function
Time frame: Up to 18 months.
Correlation of Standard Cardiac Troponin I and Highly Sensitive Cardiac Troponin T With Cardiac Events and Asymptomatic Worsening of Cardiac Function
Time frame: Up to 18 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30852761Lynce F, Barac A, Geng X, Dang C, Yu AF, Smith KL, Gallagher C, Pohlmann PR, Nunes R, Herbolsheimer P, Warren R, Srichai MB, Hofmeyer M, Cunningham A, Timothee P, Asch FM, Shajahan-Haq A, Tan MT, Isaacs C, Swain SM. Prospective evaluation of the cardiac safety of HER2-targeted therapies in patients with HER2-positive breast cancer and compromised heart function: the SAFE-HEaRt study. Breast Cancer Res Treat. 2019 Jun;175(3):595-603. doi: 10.1007/s10549-019-05191-2. Epub 2019 Mar 9.
- Results publication: PubMed 28314836Lynce F, Barac A, Tan MT, Asch FM, Smith KL, Dang C, Isaacs C, Swain SM. SAFE-HEaRt: Rationale and Design of a Pilot Study Investigating Cardiac Safety of HER2 Targeted Therapy in Patients with HER2-Positive Breast Cancer and Reduced Left Ventricular Function. Oncologist. 2017 May;22(5):518-525. doi: 10.1634/theoncologist.2016-0412. Epub 2017 Mar 17.
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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.
Sandra M Swain, MD principal investigator
Washington Cancer Institute at MedStar Washington Hospital Center
2 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 Trastuzumab, Pertuzumab and Ado Trastuzumab Emtansine in people with HER2 Positive Breast Cancer and Left Ventricular Function Systolic Dysfunction, run by Medstar Health Research Institute at 2 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 2 Feb 2021). 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?
Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function. (time frame: Up to 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904903, which also lists 2 linked publications.
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 10 May 2022.