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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
No inclusion staging is established, as the indication will be determined based on standard clinical practice.
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jose Luis Alonso Romero, MD | HCUVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCUVA | Murcia | Murcia | 30120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41557021 | Derived | 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. |
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|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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