RecruitingPhase 1NCT06900647

Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer

Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer


Sponsor

Sun Yat-sen University

Enrollment

20 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — bortezomib and cisplatin — in women with recurrent or metastatic breast cancer that has not responded to standard treatments. **You may be eligible if...** - You are a woman aged 18 or older with confirmed advanced or metastatic breast cancer - You have tumor tissue available for testing - Standard treatments have failed in your case - You have at least one measurable tumor on imaging - You are in reasonably good overall health (ECOG score of 0-2) - Your expected survival is at least 12 weeks - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have active brain metastases - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You have an active serious infection 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

DRUGBortezomib (B)

1.3mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

DRUGCisplatin (CDDP)

50mg/m2, IV, D1-3, every 3 weeks

DRUGBortezomib (B)

1.5mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

DRUGBortezomib (B)

1.7mg/m2, IV, D1, D4, D8 and D11, every 3 weeks

DRUGCisplatin (CDDP)

70mg/m2, IV, D1-3, every 3 weeks


Locations(1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06900647


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