RecruitingPhase 3NCT05552001

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis


Sponsor

UNICANCER

Enrollment

96 participants

Start Date

Oct 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to: 1. evaluate the treatment efficacy in less pretreated patients. 2. identify biomarkers that could predict response or resistance to the drug.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of a targeted antibody drug with chemotherapy in people with triple-negative metastatic breast cancer (TNBC) — a type of breast cancer that lacks the three main receptors (hormone and HER2), making it harder to treat with standard targeted drugs. **You may be eligible if...** - You are 18 years or older - You have advanced or metastatic triple-negative breast cancer confirmed by biopsy - Your disease has progressed after previous chemotherapy (including adjuvant therapy or treatment within 6 months of systemic therapy) - You are in reasonably good physical condition (ECOG 0–1) - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have untreated or active brain metastases - You have had certain prior treatments that overlap with this study's drugs - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems - You have active autoimmune disease requiring steroids 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 (SG) is given by intervenous route, 10 mg/kg on day 1 and day 8 of 21-day treatment cycles. Patient will receive treatment until disease progression, unacceptable toxicity, or decision to withdraw its participation.


Locations(1)

Gustave Roussy

Villejuif, France

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NCT05552001


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