Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Based on Dual Blockade With Pertuzumab and the Trastuzumab Biosimilar CT-P6 (Herzuma®) in Early HER2-positive Breast Cancer in Routine Clinical Practice (Her-Database)

March 31, 2025 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Prospective Multicenter Observational Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Based on Dual Blockade With Pertuzumab and the Trastuzumab Biosimilar CT-P6 (Herzuma®) in Early HER2-positive Breast Cancer in Routine Clinical Practice

The study hypothesis is to evaluate whether the pCR rate of neoadjuvant chemotherapy and dual blockade with pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in HER2-positive early breast cancer in PCH is similar to that reported in clinical trials.

Other aspects to be analyzed include the safety of the combination in PCH, as well as the clinical and tumor characteristics of the study population, assessment of radiological and pathological response, and the role of treatment-induced immunogenicity and the value of plasma HER2 determination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study hypothesis is to evaluate whether the pCR rate of neoadjuvant chemotherapy and dual blockade with pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in HER2-positive early breast cancer in PCH is similar to that reported in clinical trials.

Other aspects to be analyzed include the safety of the combination in PCH, as well as the clinical and tumor characteristics of the study population, assessment of radiological and pathological response, and the role of treatment-induced immunogenicity and the value of plasma HER2 determination.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • HCUVA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 18 years or older.
  • Diagnosis of HER2-positive breast cancer confirmed by immunohistochemistry (IHC) of 3+ or positive fluorescence in situ hybridization (FISH) result.
  • Early stage without systemic dissemination, amenable to neoadjuvant treatment with chemotherapy and dual anti-HER2 blockade with pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) according to the PCH.

No inclusion staging is established, as the indication will be determined based on standard clinical practice.

  • Clinical data available in the patient's medical record for collection.
  • Provide written informed consent for the study and informed consent for the Biobank.

Exclusion Criteria:

  • Medical or psychiatric incapacity to provide informed consent.
  • Known hypersensitivity to trastuzumab or pertuzumab.
  • Current treatment with an investigational drug.
  • Participation in a clinical trial that involves adding an investigational drug to the standard neoadjuvant clinical treatment with chemotherapy, pertuzumab, and the trastuzumab biosimilar CT-P6 (Herzuma®).
  • Withdrawal of consent to participate in the study. The patient may withdraw their consent at any time without having to justify their decision and without any detriment to their clinical care.
  • Patient who does not wish to receive or is not a candidate for oncological treatment with chemotherapy or dual anti-Her2 blockade.
  • Patient diagnosed with another prognostically relevant neoplastic disease in the previous two years. The exceptions are carcinoma in situ of the cervix or breast, and basal cell or squamous cell carcinoma of the skin.
  • Non-neoplastic disease with a prognosis of less than 1 year.
  • Medical condition or patient characteristics that, in the investigator's judgment, pose a high risk of serious complications during treatment.
  • Being pregnant or breastfeeding.
  • Inability to cooperate and comply with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast ca
Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast cancer susceptible to neoadjuvant chemotherapy.
Drug: Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast cancer susceptible to neoadjuvant chemotherapy.
Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast cancer susceptible to neoadjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR) rate
Time Frame: Up to 18 months

Pathological complete response (pCR) rate in breast and axillary tissue (ypT0/is ypN0) in patients with HER2-positive early breast cancer after receiving neoadjuvant treatment with chemotherapy, pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) according to routine clinical practice.

The standard practice for determining pRC is to follow the Miller and Payne criteria. pRC is considered to be grade 5 in tumor tissue, and grade D in the axilla.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Investigators

  • Principal Investigator: Jose Luis Alonso Romero, MD, HCUVA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2020

Primary Completion (Actual)

March 14, 2024

Study Completion (Actual)

March 14, 2024

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOCYTIMIB.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast cancer susceptible to neoadjuvant chemotherapy.

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