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

Sponsor

Libbs Farmacêutica LTDA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03892655

Collaborator

(none)

170

Enrollment

Locations

55.3

Anticipated Duration (Months)

14.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

170 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Jul 22, 2019

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2024

Outcome Measures

Primary Outcome Measures

Efficacy endpoints: Invasive disease relapse-free survival rate [18 months]
Invasive disease relapse-free survival rate
Efficacy endpoints: Invasive disease relapse-free survival rate [24 months]
Invasive disease relapse-free survival rate
Efficacy endpoints: Invasive disease relapse-free survival rate [30 months]
Invasive disease relapse-free survival rate
Efficacy endpoints: Invasive disease relapse-free survival rate [36 months]
Invasive disease relapse-free survival rate
Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery [5 years]
Invasive disease relapse-free survival after curative-intent surgery
Efficacy endpoints: Overall survival after curative intent surgery [5 years]
Overall survival after curative intent surgery
Safety endpoints: Incidence of Related Adverse Events [5 years]
Incidence of Related Adverse Events
Safety endpoints: Total cycles per patient [5 years]
Total cycles per patient
Safety endpoints: Incidence of dose interruption [5 years]
Incidence of dose interruption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	William Hiromi Fuzita	Manaus	Amazonas	Brazil	69057205
2	Daniel Fontes Santos de Teive e Argolo	Salvador	Bahia	Brazil	41810570
3	Márcia Cristina Colares Régis de Araújo	Fortaleza	Ceará	Brazil	60135285
4	João Paulo Vendas Villalba	Campo Grande	MS	Brazil	79002390
5	Sâmio Pimentel Ferreira	Belém	Pará	Brazil	66035265
6	Cláudio Rocha	Teresina	Piaui	Brazil	64049-200
7	Danielli de Almeida Matias	Natal	Rio Grande Do Norte	Brazil	59075740
8	Tomás Reinert	Caxias Do Sul	Rio Grande Do Sul	Brazil	95020450
9	Giuliano Santos Borges	Itajaí	Santa Catarina	Brazil	88301220
10	Raquel Pedro Moreira	Araraquara	São Paulo	Brazil	14802408
11	Daniel Grabarz	Mogi Das Cruzes	São Paulo	Brazil	08730500
12	Monique Celeste Tavares	São Paulo		Brazil	01509-900