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Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer (LB1802)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892655
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Libbs Farmacêutica LTDA

Study Description
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Brief Summary:

Zedora registration was based on studies of women with metastatic breast cancer, but its approval includes adjuvant treatment. Thus, prospective data of drug use in localized disease are lacking, as well as are real-world safety and efficacy data, taking into consideration comorbidities and compliance difficulties.

This will be an observational study of patients receiving adjuvant Zedora at several Brazilian institutions for the purpose of describing its efficacy and safety.


Condition or disease
Breast Cancer

Detailed Description:

An observational, multicenter, prospective, real-world study at Brazilian institutions.

Adult patients with early HER2+ breast cancer receiving adjuvant biosimilar trastuzumab (Zedora) at the participating sites after the start of the study and meeting the eligibility criteria will be invited to participate. Demographics, comorbidities, disease history, extent of exposure to biosimilar trastuzumab (Zedora), adverse events and LVEF values will be collected.

Data collection will be performed using a case report form (CRF) specifically designed for the study.

Study Treatment:

Biosimilar trastuzumab (Zedora) must be prescribed at the dosage described in the product label.

Treatment duration will be 12 months for patients starting upfront with biosimilar trastuzumab (Zedora). Patients switching at any time to biosimilar trastuzumab (Zedora) after a period of adjuvant or neoadjuvant Herceptin® use will also be included in the overall analysis and subsequently assessed in a subgroup analysis.

Sample Size:

Number of patients = 170 Given the inexistence of a specific hypothesis to be tested, the statistical analysis will be basically descriptive.

Sample size is based on the two-sided 95% confidence interval (95% CI) for the invasive disease relapse-free survival rate.

The table below shows the 95% CIs for different rates in a sample of 170 patients, with an interval size ranging between 9% and 15%.

Based on literature, a 3-year relapse-free survival between 88 and 96% is expected. According to the table above, a sample of 170 patients allows assessing this endpoint with +/- 6.0% accuracy.

Study duration:

The estimated time for patient enrollment in the study is one year and may be extended in case the sample size is not reached in this period. Biosimilar trastuzumab (Zedora) must be prescribed according to the product label and treatment duration will be up to one year. The patient will be maintained in the study for 5 years (from start of treatment), unless there is tumor recurrence (local or distant).

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Multicenter, Prospective, Real World, National Study to Assess the Efficacy and Safety of Adjuvant Biosimilar Tratuzumab (Zedora) Treatment in Patients With Localized Her2 Positive Breast Cancer
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 18 months ]
    Invasive disease relapse-free survival rate

  2. Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 24 months ]
    Invasive disease relapse-free survival rate

  3. Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 30 months ]
    Invasive disease relapse-free survival rate

  4. Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 36 months ]
    Invasive disease relapse-free survival rate

  5. Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery [ Time Frame: 5 years ]
    Invasive disease relapse-free survival after curative-intent surgery

  6. Efficacy endpoints: Overall survival after curative intent surgery [ Time Frame: 5 years ]
    Overall survival after curative intent surgery

  7. Safety endpoints: Incidence of Related Adverse Events [ Time Frame: 5 years ]
    Incidence of Related Adverse Events

  8. Safety endpoints: Total cycles per patient [ Time Frame: 5 years ]
    Total cycles per patient

  9. Safety endpoints: Incidence of dose interruption [ Time Frame: 5 years ]
    Incidence of dose interruption


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult female patients with diagnosis of early stage I to III HER2+ breast cancer confirmed by histopathology test, immunohistochemistry test and FISH, where required, according to local guidelines, and who have started biosimilar trastuzumab (Zedora) as neoadjuvant or adjuvant therapy according to the product label will be eligible for the study.
Criteria

Inclusion Criteria:

  • female patients aged 18 years and over
  • diagnosis of early stage I to III breast cancer confirmed by histopathology test according to local guidelines.
  • human epidermal growth factor receptor 2 (HER2)-positive tumor by immunohistochemistry or FISH (Fluorescence In Situ Hybridization), as per the 2018 ASCO assessment guideline [J Clin Oncol 36:2105, 2018].
  • use of at least one dose of biosimilar trastuzumab (Zedora) as adjuvant therapy, regardless of previous neoadjuvant trastuzumab or Zedora use or the type of chemotherapy combined with the antibody.
  • Signing of the informed consent form (ICF).

Exclusion Criteria:

  • use of biosimilar trastuzumab (Zedora) differently from the provisions in the label.
  • patients enrolled in and followed up by Programa Vida Plena [Full Life Program].
Contacts and Locations
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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): NCT03892655


Contacts
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Contact: Augusto T Figueiredo, Analyst 55 11 2109 2500 ext 1246 augusto.figueiredo@libbs.com.br
Contact: Vivienne C Castilho, Manager 55 11 2109 2500 ext 1568 vivienne.castilho@libbs.com.br

Locations
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Brazil
William Hiromi Fuzita Recruiting
Manaus, Amazonas, Brazil, 69057205
Contact: Lia M Ono, DDS PhD       isenp@isenp.org   
Principal Investigator: William H Fuzita, Doctor         
Daniel Fontes Santos de Teive e Argolo Recruiting
Salvador, Bahia, Brazil, 41810570
Contact: Daniel Argolo, Dr    55 71 2141-5941    'daniel.argolo@clion.com.br'   
Contact: Aline Nascimento    55 71 2141-5941    pesquisa@clion.com.br   
Principal Investigator: Daniel Argolo, Dr         
Márcia Cristina Colares Régis de Araújo Recruiting
Fortaleza, Ceará, Brazil, 60135285
Contact: Genilson Monteiro    85987858665    pesquisa@colv.com.br   
Contact: Genilson Monteiro    85998509342    pesquisa@colv.com.br   
Principal Investigator: Márcia Araújo, Doctor         
João Paulo Vendas Villalba Recruiting
Campo Grande, MS, Brazil, 79002390
Contact: João P Villalba, Dr    55 67 41413499    joaopaulo@nio.med.br   
Contact: Thais Lopes, MSc    55 67 41413499    thaislopes@nio.med.br   
Principal Investigator: João P Villalba, Dr         
Sâmio Pimentel Ferreira Recruiting
Belém, Pará, Brazil, 66035265
Contact: Fabia Assunção    91 3232 1009    fabiadearaujo@yahoo.com.br   
Contact: Eliude Nascimento       doutoraeli@gmail.com   
Principal Investigator: Sâmio Pimentel, Dr         
Cláudio Rocha Recruiting
Teresina, Piaui, Brazil, 64049-200
Contact: Cláudio Rocha, Doctor    +55 86 3194-500    vencerpesquisaclinica@gmail.com   
Contact: Fernanda Bitencourt    +55 86 3194-500    vencerpesquisaclinica@gmail.com   
Principal Investigator: Cláudio Rocha, Doctor         
Danielli de Almeida Matias Recruiting
Natal, Rio Grande Do Norte, Brazil, 59075740
Contact: Danielli A Matias, Dr    55 84 4009 7401    dani25matias@yahoo.com.br   
Principal Investigator: Danielli A Matias, Dr         
Tomás Reinert Recruiting
Caxias Do Sul, Rio Grande Do Sul, Brazil, 95020450
Contact: Monique Binoto    55 54 984373022    monique.binotto@devita.com.br   
Principal Investigator: Tomas Reinert, Doctor         
Giuliano Santos Borges Recruiting
Itajaí, Santa Catarina, Brazil, 88301220
Contact: Giuliano S Borges, Dr    55 47 3348-5093    giuliano_borges@yahoo.com.br   
Principal Investigator: Giuliano S Borges, Dr         
Raquel Pedro Moreira Recruiting
Araraquara, São Paulo, Brazil, 14802408
Contact: Gabriella P Remedi    55 51 99159-1861    gpremedi@gmail.com   
Principal Investigator: Raquel P Moreira         
Daniel Grabarz Recruiting
Mogi Das Cruzes, São Paulo, Brazil, 08730500
Contact: Daniel Grabarz, Dr    (11) 4795-4795    pesquisaclinica@centrooncologico.com.br   
Contact: Leila Oliveira    (11) 4795-4795    pesquisaclinica@centrooncologico.com.br   
Principal Investigator: Daniel Grabarz, Dr         
Monique Celeste Tavares Recruiting
São Paulo, Brazil, 01509-900
Contact: Monique C Tavares, Doctor    +55 11 2189-5000 ext 5138    monique.tavares@accamargo.org.br   
Contact: Joao Paulo S Lima, Doctor    +55 11 2189-5000 ext 5138    joao.lima@accamargo.org.br   
Principal Investigator: Monique C Tavares, Doctor         
Sub-Investigator: Joao Paulo S Lima, Doctor         
Sponsors and Collaborators
Libbs Farmacêutica LTDA
More Information
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Additional Information:

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Responsible Party: Libbs Farmacêutica LTDA
ClinicalTrials.gov Identifier: NCT03892655    
Other Study ID Numbers: LB1802
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Libbs Farmacêutica LTDA:
breast carcinoma
receptors 2 (HER2)
biosimilar
trastuzumab
Zedora
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases