RecruitingPhase 2NCT06236269

HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan

Prospective Biomarker Analysis in HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan


Sponsor

SOLTI Breast Cancer Research Group

Enrollment

50 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+/HER2- advanced/metastatic breast cancer patients


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world data on how sacituzumab govitecan (an antibody-drug that targets cancer cells) works in patients with advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer whose disease has progressed after CDK4/6 inhibitor therapy. **You may be eligible if...** - You are 18 or older (male or female) - You have been diagnosed with advanced or metastatic breast cancer that is HR-positive and HER2-negative - Your cancer has progressed during or after CDK4/6 inhibitor treatment - You are in reasonably good general health **You may NOT be eligible if...** - Your cancer is not classified as HR+/HER2- - Your disease has not progressed after CDK4/6 inhibitor therapy - You are not in adequate general health for treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan

Sacituzumab Govitecan 10 mg/kg will be administrad intravenously (IV) on Days 1, 8 of a 21-day cycle


Locations(10)

ICO Badalona

Badalona, Barcelona, Spain

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

HU Clínico San Cecilio

Granada, Spain

Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Sant Joan de Reus

Reus, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clínico de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06236269


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