Clinical trial NCT03892655: Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: breast carcinoma
receptors 2 (HER2)
biosimilar
trastuzumab
Zedora
Lead sponsor: Libbs Farmacêutica LTDA
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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 \[Full Life Program\].

Primary outcomes:
measure: Efficacy endpoints: Invasive disease relapse-free survival rate
timeFrame: 18 months
measure: Efficacy endpoints: Invasive disease relapse-free survival rate
timeFrame: 24 months
measure: Efficacy endpoints: Invasive disease relapse-free survival rate
timeFrame: 30 months
measure: Efficacy endpoints: Invasive disease relapse-free survival rate
timeFrame: 36 months
measure: Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery
timeFrame: 5 years
measure: Efficacy endpoints: Overall survival after curative intent surgery
timeFrame: 5 years
measure: Safety endpoints: Incidence of Related Adverse Events
timeFrame: 5 years
measure: Safety endpoints: Total cycles per patient
timeFrame: 5 years
measure: Safety endpoints: Incidence of dose interruption
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: William Hiromi Fuzita
state: Amazonas
city: Salvador
country: Brazil
facility: Daniel Fontes Santos de Teive e Argolo
state: Bahia
city: Fortaleza
country: Brazil
facility: Márcia Cristina Colares Régis de Araújo
state: Ceará
city: Cachoeiro De Itapemirim
country: Brazil
facility: Raphael Luzorio Fernandes
state: Espírito Santo
city: Cachoeiro De Itapemirim
country: Brazil
facility: Sabina Bandeira Aleixo
state: Espírito Santo
city: Goiânia
country: Brazil
facility: Ruffo de Freitas Junior
state: Goiás
city: Três Lagoas
country: Brazil
facility: Luis Eduardo Rosa Zucca
state: Mato Grosso Do Sul
city: Campo Grande
country: Brazil
facility: Cristina de Deus Anjos Tavares Sampaio
state: Mato Grosso
city: Muriaé
country: Brazil
facility: Micheline Campos Rezende
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Karina Costa Maia Vianna
state: Paraná
city: Curitiba
country: Brazil
facility: Sérgio Lunardon Padilha
state: Paraná
city: Belém
country: Brazil
facility: Sâmio Pimentel Ferreira
state: Pará
city: Teresina
country: Brazil
facility: Cláudio Rocha
state: Piaui
city: Natal
country: Brazil
facility: Danielli de Almeida Matias
state: Rio Grande Do Norte
city: Caxias Do Sul
country: Brazil
facility: Tomas Reinert
state: Rio Grande Do Sul
city: Ijuí
country: Brazil
facility: Rafaela Kirchner Piccoli
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Mateus Bongers Alessandretti
state: Rio Grande Do Sul
city: Lages
country: Brazil
facility: Charles Alain Cordova Pinto
state: Santa Catarina
city: Mogi Das Cruzes
country: Brazil
facility: Daniel Grabarz
state: São Paulo
city: São Paulo
country: Brazil
facility: Monique Celeste Tavares
city: São Paulo
country: Brazil
facility: Kaique Almeida
city: São Paulo
country: Brazil
facility: Mariana Scaranti
Study officials:
References: