RecruitingPhase 4NCT04136782

Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer

Albumin-bound Paclitaxel Combined With Carboplatin Versus Epirubicin Combined With Docetaxel as Neoadjuvant Therapy for Triple-negative Breast Cancer: a Multicenter Randomized Controlled Phase IV Clinical Trial

Sponsor

Shengjing Hospital

Enrollment

110 participants

Start Date

Jul 19, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy regimens for women with triple-negative breast cancer (a type that lacks estrogen, progesterone, and HER2 receptors) to see which works better when given before surgery. **You may be eligible if...** - You have confirmed triple-negative breast cancer (hormone receptors negative, HER2 negative) - Your cancer is stage II or III (not spread to distant areas) - You are between 18 and 70 years old - Your general health score (Karnofsky) is 70 or above - Your blood counts, liver, kidney, and heart function are within normal or near-normal limits - Your estimated survival is more than 3 months **You may NOT be eligible if...** - Your cancer has spread to the bone or other distant organs (stage IV) - You have serious heart, lung, or kidney disease that makes chemotherapy unsafe - You have already received cancer treatment - You have a history of other malignant tumors - 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

DRUGAlbumin-bound paclitaxel combined with carboplatin

Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel (Abraxis BioScience, LLC., Mclrose Park, IL, USA; certificate number: H20091059) will be intravenously administered at 125 mg/m2 for 30 minutes on days 1 and 8 of each 21-day session of treatment. There will be six 21-day sessions of treatment. At the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; National Drug Approval Number: H20020181) will be intravenously administered at AUC = 2 mg•min/mL for 120 minutes on days 1 and 8 of each 21-day session of treatment. Carboplatin must be hydrated for 3 days before use to prevent nephrotoxicity.

DRUGEpirubicin combined with docetaxel

Epirubicin (Pfizer Pharmaceutical (Wuxi) Co., Ltd., China; National Drug Approval Number: H20000496) will be intravenously administered at 90 mg/m2 for 120 minutes on day 1 of each 21-day session of treatment. At the same time, docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; National Drug Approval Number: J20150083) will be intravenously administered at 75 mg/m2 for 120 minutes. Drug administration will be performed once every other 3 weeks for four times.