Status:
COMPLETED
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
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 can...
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 can...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06907082
Start Date
December 28 2020
End Date
March 14 2024
Last Update
April 2 2025
Active Locations (1)
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1
HCUVA
Murcia, Murcia, Spain, 30120