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

Cyclophosphamide

Epirubicin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Experimental group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles

Control group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles

Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles

Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel

Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles

Epirubicin, Cyclophosphamide, Docetaxel

Hongchao Tang

Xuli Meng

Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer

1. To evaluate the safety and effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer under the condition of widespread use.
2. To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.

Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer

A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer

After preliminary results are available, it is advisable to decide whether to share them with other researchers.

Zhejiang Provincial People's Hospital

Chief physician

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Cardiotoxicity

Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles

Treatment Arm 2: TC - docetaxel (Taxotere) (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.

* Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.
* Treatment Arm 2: TC - docetaxel (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.

epirubicin, cyclophosphamide, docetaxel

Lissandra Dal Lago, MD

Evandro De Azambuja, MD

The primary objective is to evaluate the difference in cardiac strain rate evolution in elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT.

This study also will compare the serum biomarkers profile during and after the (neo) adjuvant CT in both treatment arms, assess whether MRI allows detecting earlier than standard echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess whether brain PET-CT allows detecting regional functional impairment in patients receiving CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms, evaluate distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate psychological state and burden of primary caregivers before and after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the Framingham risk score for Hard Coronary Heart Disease (10-year risk).

Considering that both anthracycline-based and Taxotere-cyclophosphamide CT have established efficacy in the adjuvant treatment of elderly patients with early breast cancer, and the paucity of data for early cardiac toxicities with anthracycline-based adjuvant therapy compared to non-anthracycline regimen, this is the first randomized study to evaluate early cardiac signs based on doppler myocardial imaging (DMI). The results of this study could improve the monitoring of the cardiac function of elderly patients candidates to receive adjuvant chemotherapy for early breast cancer.

Early Cardiac Toxicity of Adjuvant CT in Elderly BC.

Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.)

The primary null hypothesis is that the means are equal versus the alternative hypothesis that the means are different. We plan to perform the comparison using a two-sided Student's t-test with α=5%. The power of the study to detect the difference described below has been set at 90%.

One hundred twenty patients candidate to receive neoadjuvant or adjuvant CT for early BC will be randomized 1:1 to receive either epirubicin-cyclophosphamide (EC) or docetaxel (Taxotere) -cyclophosphamide (TC) for 4 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer	NCT05914753	Breast Cancer Chemotherapy Ef...	Epirubicin, Cyc... Epirubicin, Cyc...	18 Years - 80 Years	Zhejiang Provincial People's Hospital
Early Cardiac Toxicity of Adjuvant CT in Elderly BC.	NCT01301040	Breast Cancer	epirubicin, cyc...	65 Years -	Jules Bordet Institute
Early Cardiac Toxicity of Adjuvant CT in Elderly BC.	NCT01301040	Breast Cancer	epirubicin, cyc...	65 Years -	Jules Bordet Institute

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