Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date February 12, 2019
First Posted Date March 27, 2019
Last Update Posted Date April 8, 2020
Actual Study Start Date July 22, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
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.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 26, 2019)
170
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2024
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
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].
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03892655
Other Study ID Numbers LB1802
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Libbs Farmacêutica LTDA
Study Sponsor Libbs Farmacêutica LTDA
Collaborators Not Provided
Investigators Not Provided
PRS Account Libbs Farmacêutica LTDA
Verification Date January 2020