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

NCT06907082 | Completed

• 1 other identifier: GOCYTIMIB.01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast ca

EXPERIMENTAL

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.

Interventions

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 ca

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients to be included will be those diagnosed with HER2-positive early breast cancer amenable to neoadjuvant treatment with chemotherapy and dual anti-HER2 blockade. Patients will be treated at the hospitals included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

HCUVA

Murcia, Murcia, 30120, Spain

Location

Related Publications (1)

• Alonso-Romero JL, Martinez-Garcia J, Carrillo-Vicente R, Aramburo AF, Diez AF, Henarejos PS, de la Morena Barrio P, Boix AP, Jimenez MD, Siles JP, Maestre JAP, de Las Heras-Rubio A, Carreno PR. Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer. Breast Cancer Res Treat. 2026 Jan 20;215(2):60. doi: 10.1007/s10549-026-07895-8.

  PMID: 41557021 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jose Luis Alonso Romero, MD

  HCUVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 2, 2025
• Study Start: December 28, 2020
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)