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)

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: Breast Cancer
• Intervention / Treatment: Drug: Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast cancer susceptible to neoadjuvant chemotherapy.

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

Study Locations

• Spain
  • Murcia, Spain, 30120
    • HCUVA

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

• 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

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: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Trastuzumab; Pertuzumab
• 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