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Cardiotoxicity in Metastatic Her 2 Positive Patients Treated With Trastuzumab ,Pertuzumab and Taxanes

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ClinicalTrials.gov Identifier: NCT02101879
Recruitment Status : Unknown
Verified May 2014 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : April 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:

Approximately 15-25% of all breast cancers are human epidermal growth factor receptor 2 (HER2) positive and it has been well known that HER2 overexpression is associated with more aggressive phenotype and poor prognosis with resistance to certain chemotherapeutic agents.

Trastuzumab administration as an adjuvant and in metastatic HER2 positive breast cancer is associated with both symptomatic and asymptomatic cardiotoxicity. The incidence of trastuzumab-mediated cardiotoxicity were 27% with antracycline combination and 13% when it was administered with paclitaxel .

Pertuzumab, a recombinant humanized monoclonal antibody binding to the HER2 dimerization domain, prevents dimerization of HER2 with other HER receptors (HER3,HER1, and HER4) especially with HER3. Blocking HER2-HER3 dimerization is postulated to be the most clinically relevant action of pertuzumab and this can effectively block her2-mediated cell signaling.

Pertuzumab is indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Treatment of breast cancer with pertuzumab plus trastuzumab plus docetaxel as first line treatment until disease progression might be complicated by cardiotoxicity in up to 14.5% of the Patients.

Cardinale et al showed that troponin I (TNI) positive identifies trastuzumab-treated patients who are at risk for cardiotoxicity and are unlikely to recover from cardiac dysfunction despite HF therapy.

There is very little data about the reversibility and identification of patients at risk for cardiotoxicity of the pertuzumab plus trastuzumab plus docetaxel regimen and of those who will not recover from cardiac dysfunction,this information is crucial. The usefulness of troponin I (TNI) and Brain natriuretic peptide (BNP) in the identification of patients at risk for PT cardiotoxicity and in the prediction of LVEF recovery has never been investigated.

based on this background , this study aim is to evaluate the cardiotoxicity of pertuzumab plus trastuzumab plus docetaxel regimen and the application of troponin I (TNI) and Brain natriuretic peptide (BNP) in this setting.


Condition or disease
Cardiotoxicity. Anti Her2 Therapy. Metastatic Breast Cancer

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Cardiotoxicity in Metastatic Her 2 Positive Patients Treated With First Line Trastuzumab, Pertuzumab and Taxanes Based Regimen
Study Start Date : May 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Breast cancer Her2 positive
Trastuzumab & Pertuzumab & Taxanes



Primary Outcome Measures :
  1. To assesses blood levels of TNI and BNP during the first four cycles Trastuzumab&Pertuzumab and Taxanes treatment [ Time Frame: The patients will be followed until the end of therapy (an expected average of 18 months). ]
    Prior to every treatment cycle, blood samples will be taken for TNI & BNP. Patients with elevated levels will be sent for LEVF evaluation. In cases with LEVF reduction of 15% or more from the baseline or LEVF less than 50% will be sent for Cardiological consult in order to consider ACEI or BB treatment

  2. To evaluate the correlation between elevated TNI&BNP and decline of LVEF on echocardiography until end of treatment. [ Time Frame: The patients will be followed until the end of therapy (an expected average of 18 months). ]
    Prior to every treatment cycle, blood samples will be taken for TNI & BNP. Patients with elevated levels will be sent for LEVF evaluation. In cases with LEVF reduction of 15% or more from the baseline or LEVF less than 50% will be sent for Cardiological consult in order to consider ACEI or BB treatment


Biospecimen Retention:   Samples Without DNA
Blood samples for TNI & BNP will be sent before every cycle for the first 5 cycles of treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Metastatic Breast Cancer Her2 Positive
Criteria

Inclusion Criteria:

  • Metastatic Breast Cancer patients with Her2 Positive Disease.
  • No prior treatment

Exclusion Criteria:

  • LEVF less than 50%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101879


Contacts
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Contact: Georgeta Fried, MD +972-4-854-3018 g_fried@rambam.health.gov.il

Locations
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Israel
Rambam MC Recruiting
Haifa, Israel
Principal Investigator: Georgeta Fried, MD         
Sub-Investigator: Shlomit Shachar-Strulov, MD         
Sponsors and Collaborators
Rambam Health Care Campus

Additional Information:

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02101879     History of Changes
Other Study ID Numbers: Cardiotoxicity
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Pertuzumab
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Trastuzumab
Taxane
Antineoplastic Agents, Immunological
Antineoplastic Agents