RecruitingPhase 3NCT05760378

Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.

An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer


Sponsor

Fudan University

Enrollment

223 participants

Start Date

Mar 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — famitinib (blocks tumor blood vessel growth), camrelizumab (an immunotherapy), and standard chemotherapy — as a first-line treatment for triple-negative breast cancer (TNBC) that is locally advanced or has spread to other parts of the body. TNBC is an aggressive form of breast cancer that lacks the three common receptors. **You may be eligible if...** - You have triple-negative breast cancer (no HER2, estrogen, or progesterone receptors) confirmed by biopsy - Your cancer is locally advanced or metastatic - You have not had previous chemotherapy or targeted therapy for this stage of disease - Your overall health is good (ECOG 0–1) with a life expectancy of at least 3 months **You may NOT be eligible if...** - You have already received chemotherapy or targeted therapy for metastatic/advanced disease - You have active autoimmune disease or serious infections - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGFamitinib

TKI

DRUGCamrelizumab

PD1 inhibitor

DRUGnab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin

TPC


Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT05760378


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