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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Chemotherapy Effect
• Intervention / Treatment: Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel; Drug: Epirubicin, Cyclophosphamide, Docetaxel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongchao Tang; Phone Number: +8613282037232; Email: thc0571@live.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Biopsy of breast mass was performed under ultrasound-guided treatment before neoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmed pathologically, followed by immunohistochemical examination. Pathological sections before and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more senior pathologists, and there were consistent definite conclusions.
2. Have detailed and complete clinicopathological data;
3. Diagnosis data of TCM syndrome type;
4. No biopsy-confirmed lymph node metastasis;
5. No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment;
6. At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery;
7. Under the guidance of doctors, take Xihuang pills in a standardized way throughout the whole process and review regularly;
8. The patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy;
9. All patients were newly diagnosed

Exclusion Criteria:

1. Concurrent malignant tumors of other sites;
2. Patients with distant metastasis
3. Male breast cancer
4. Patients who did not receive full-course standardized neoadjuvant chemotherapy;
5. Lost contact or dropped out of the study, unable to follow up;
6. Inability to tolerate chemotherapy responses;
7. Intolerant to Xihuang Wan and unable to take it;
8. The patient has strong side effects of chemotherapy and cannot tolerate chemotherapy drugs;
9. Inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer;
10. Various other possible influences.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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	Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel; 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
Placebo Comparator: Control group; 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	Drug: Epirubicin, Cyclophosphamide, Docetaxel; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response (pCR)	Pathological complete response	six months

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Investigators: Study Chair: Xuli Meng, Zhejiang Provincial people's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Epirubicin
• Other Study ID Numbers: XHWBC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After preliminary results are available, it is advisable to decide whether to share them with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No