RecruitingPhase 2NCT04138719

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

520 participants

Start Date

Nov 20, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open, randomized, comparison study. 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. Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery. The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application. The total number of patients to be included in this study is 520 patients.


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 triple-negative breast cancer (a type that lacks estrogen, progesterone, and HER2 receptors) given before surgery to shrink the tumor — testing whether nab-paclitaxel plus carboplatin works better than nab-paclitaxel plus epirubicin. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have confirmed triple-negative breast cancer by biopsy - Your tumor is larger than 2 cm - You are planning to receive chemotherapy before surgery - Your blood counts, heart function (LVEF ≥ 55%), liver and kidney function are within acceptable levels **You may NOT be eligible if...** - You have previously received any chemotherapy, radiation, or hormone therapy - You have significant heart disease (NYHA grade II or above) - You have a serious active infection or other major illness - You have had another cancer in the past 5 years (except some cured skin cancers) - You are pregnant or breastfeeding - You are participating in another clinical trial 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 + Epirubicin

nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and epirubicin given IV at 75 mg/m\^2 on days 1 every 21 days x 6 cycles;


Locations(1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

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NCT04138719


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