RecruitingPhase 3NCT05901428

TCb vs EC-T in High Risk ER+/HER2- Breast Cancer

A Randomized, Open-label, Single-center, Phase III Trial Comparing Docetaxel Plus Carboplatin (TCb) Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel (EC-T) Regimen as Adjuvant Chemotherapy in Patients With LN≥4 Estrogen Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Breast Cancer

Sponsor

Fudan University

Enrollment

1,736 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Hormone Receptor Positive HER-2 Negative Breast Cancer

Summary

This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two chemotherapy regimens (TCb versus EC-T) in women with high-risk HR-positive, HER2-negative breast cancer with 4 or more positive lymph nodes after surgery. **You may be eligible if...** - You are a woman aged 18–70 - You have HR-positive, HER2-negative invasive breast cancer with 4 or more positive axillary lymph nodes - Your tumor was completely removed with no remaining cancer - Your performance status is good (ECOG 0–1) and organ function meets requirements - Chemotherapy is starting within 8 weeks of surgery **You may NOT be eligible if...** - You have evidence of cancer spread (metastasis) - You have peripheral neuropathy or had previous breast cancer treatment - Your blood counts or organ function do not meet the required levels 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

DRUGDocetaxel

Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer

DRUGCarboplatin

Carboplatin is a deoxyribonucleic acid (DNA) synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.

DRUGEpirubicin

Epirubicin is an antineoplastic agent derived from doxorubicin.Epirubicin, like doxorubicin, exerts its antitumor effects by interference with the synthesis and function of DNA and is most active during the S phase of the cell cycle.

DRUGCyclophosphamide

Cyclophosphamide is a nitrogen mustard that exerts its anti-neoplastic effects through alkylation.

Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT05901428

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