Clinical Trial: NCT06907082
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
Status:
COMPLETEDPhase:
Not Applicable| Lead Sponsor: | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Information Provided By: | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Last Update Posted: | 2025-04-02 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast cancer susceptible to neoadjuvant chemotherapy.
Other Study ID Numbers
- GOCYTIMIB.01
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Information Provided By: | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Last Update Posted: | 2025-04-02 |
Study Overview
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Combination of pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in Her2-positive breast cancer susceptible to neoadjuvant chemotherapy.
Other Study ID Numbers
- GOCYTIMIB.01