Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Docetaxel

Carboplatin

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Estrogens

Epirubicin

Mitogens

Taxane

Mechlorethamine

Nitrogen Mustard Compounds

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Chemotherapy: Intensive intravenous dose of docetaxel (75 mg/m2) + intravenous (IV) carboplatin \[area under the curve (AUC) =5-6\] repeated administration of Q3W for a total of 6 doses

Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q3W for a total of 4 doses, followed by (IV) docetaxel (80 mg/m2) (Q3W) for 4 doses

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

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

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.

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

Zhi-Ming Shao, MD

Lei Fan, MD

Min He, MD

Linxiaoxi Ma, MD

Ying Zhou

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.

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

Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0

Registration of differences in quality of life between the two groups in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.

Fudan University

Director of General Surgery of Fudan Shanghai Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer	NCT05901428	Hormone Recepto...	Docetaxel Carboplatin Epirubicin Cyclophosphamid...	18 Years - 70 Years	Fudan University
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer	NCT05901428	Hormone Recepto...	Docetaxel Carboplatin Epirubicin Cyclophosphamid...	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for ln≥4

Every month we try and update this database with for ln≥4 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ln≥4

Every month we try and update this database with for ln≥4 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ln≥4 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.