Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer (LB1802)
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|ClinicalTrials.gov Identifier: NCT03892655|
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : June 1, 2021
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|
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.
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.
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.
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||170 participants|
|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 :||December 2021|
|Estimated Study Completion Date :||March 2024|
- Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 18 months ]Invasive disease relapse-free survival rate
- Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 24 months ]Invasive disease relapse-free survival rate
- Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 30 months ]Invasive disease relapse-free survival rate
- Efficacy endpoints: Invasive disease relapse-free survival rate [ Time Frame: 36 months ]Invasive disease relapse-free survival rate
- Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery [ Time Frame: 5 years ]Invasive disease relapse-free survival after curative-intent surgery
- Efficacy endpoints: Overall survival after curative intent surgery [ Time Frame: 5 years ]Overall survival after curative intent surgery
- Safety endpoints: Incidence of Related Adverse Events [ Time Frame: 5 years ]Incidence of Related Adverse Events
- Safety endpoints: Total cycles per patient [ Time Frame: 5 years ]Total cycles per patient
- Safety endpoints: Incidence of dose interruption [ Time Frame: 5 years ]Incidence of dose interruption
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
|Contact: Augusto T Figueiredo, Analyst||55 11 2109 2500 ext email@example.com|
|Contact: Vivienne C Castilho, Manager||55 11 2109 2500 ext firstname.lastname@example.org|
|William Hiromi Fuzita||Recruiting|
|Manaus, Amazonas, Brazil, 69057205|
|Contact: Lia M Ono, DDS PhD email@example.com|
|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 'firstname.lastname@example.org'|
|Contact: Aline Nascimento 55 71 2141-5941 email@example.com|
|Principal Investigator: Daniel Argolo, Dr|
|Márcia Cristina Colares Régis de Araújo||Recruiting|
|Fortaleza, Ceará, Brazil, 60135285|
|Contact: Genilson Monteiro 85987858665 firstname.lastname@example.org|
|Contact: Genilson Monteiro 85998509342 email@example.com|
|Principal Investigator: Márcia Araújo, Doctor|
|João Paulo Vendas Villalba||Recruiting|
|Campo Grande, MS, Brazil, 79002390|
|Contact: João P Villalba, Dr 55 67 41413499 firstname.lastname@example.org|
|Contact: Thais Lopes, MSc 55 67 41413499 email@example.com|
|Principal Investigator: João P Villalba, Dr|
|Sâmio Pimentel Ferreira||Recruiting|
|Belém, Pará, Brazil, 66035265|
|Contact: Fabia Assunção 91 3232 1009 firstname.lastname@example.org|
|Contact: Eliude Nascimento email@example.com|
|Principal Investigator: Sâmio Pimentel, Dr|
|Teresina, Piaui, Brazil, 64049-200|
|Contact: Cláudio Rocha, Doctor +55 86 3194-500 firstname.lastname@example.org|
|Contact: Fernanda Bitencourt +55 86 3194-500 email@example.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 firstname.lastname@example.org|
|Principal Investigator: Danielli A Matias, Dr|
|Caxias Do Sul, Rio Grande Do Sul, Brazil, 95020450|
|Contact: Monique Binoto 55 54 984373022 email@example.com|
|Principal Investigator: Tomas Reinert, Doctor|
|Giuliano Santos Borges||Recruiting|
|Itajaí, Santa Catarina, Brazil, 88301220|
|Contact: Giuliano S Borges, Dr 55 47 3348-5093 firstname.lastname@example.org|
|Principal Investigator: Giuliano S Borges, Dr|
|Raquel Pedro Moreira||Recruiting|
|Araraquara, São Paulo, Brazil, 14802408|
|Contact: Gabriella P Remedi 55 51 99159-1861 email@example.com|
|Principal Investigator: Raquel P Moreira|
|Mogi Das Cruzes, São Paulo, Brazil, 08730500|
|Contact: Daniel Grabarz, Dr (11) 4795-4795 firstname.lastname@example.org|
|Contact: Leila Oliveira (11) 4795-4795 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Joao Paulo S Lima, Doctor +55 11 2189-5000 ext 5138 email@example.com|
|Principal Investigator: Monique C Tavares, Doctor|
|Sub-Investigator: Joao Paulo S Lima, Doctor|