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Early On-treatment Transcriptional Profiling as Predictor of Response in Early-stage HER2-positive Breast Cancer

NCT05912062 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-09-29

No results posted yet for this study

Summary

Non-randomized, open label, translational research study in women with early HER2-positive invasive breast carcinoma eligible for neoadjuvant treatment.

The aim of BIONHER is to assess the impact of short-term neoadjuvant dual HER2-blockade on HER2-positive breast cancer transcriptomic profile and to evaluate whether early on treatment tumor biopsy can improve the accuracy of predicting response over the pre-treatment alone.

Conditions

Interventions

DRUG

Trastuzumab (neoadjuvant)

Trastuzumab loading dose at 8mg/kg at day 1 followed by Trastuzumab at 6mg/kg in a 21-day cycle for six cycles

DRUG

Pertuzumab (neoadjuvant)

Pertuzumab loading dose at 840mg at day 1 followed by Pertuzumab at 420mg in a 21-day cycle for six cycles

DRUG

Paclitaxel (neoadjuvant)

Paclitaxel starting at day 8 at 80mg/m2, days 1, 8, and 15 of a 21-day cycle for up to fifteen weeks

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundación Sociedad Española de Oncologia Médica

    collaborator OTHER

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER

  • Reveal Genomics (Registered trademark)

    collaborator UNKNOWN

  • Institut Català d'Oncologia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2024-06-01
Completion
2024-12-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912062 on ClinicalTrials.gov