RecruitingPhase 2NCT04159142

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

414 participants

Start Date

Nov 20, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy combinations for women with advanced triple-negative breast cancer (TNBC) — a type of breast cancer that lacks the three most common receptors, making it harder to treat with targeted therapies. Patients will receive either nab-paclitaxel plus carboplatin, or nab-paclitaxel plus capecitabine, to determine which combination works better. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have confirmed triple-negative breast cancer that is locally advanced or metastatic - You have received no more than one prior chemotherapy regimen for advanced disease - Your cancer is measurable on imaging - You are in reasonably good health (ECOG 0 or 1) and your liver, kidneys, and blood counts are within acceptable ranges - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have received more than one prior chemotherapy regimen for your advanced disease - Your organ function is significantly impaired 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

DRUGNab-paclitaxel + Carboplatin

nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles;

DRUGNab-paclitaxel + Capecitabine

Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles;


Locations(1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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NCT04159142


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