Comparative Efficacy of Xiaopi Granules and Decoction in Triple-negative Breast Cancer: a Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2026-03-30
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this clinical trial is to compare the efficacy of xiaopi granules and decoction in improving the pathological complete response (pCR) of neoadjuvant chemotherapy of triple-negative breast cancer. The main objective aims to answer whether Xiaopi granules combined with neoadjuvant Chemotherapy could improve the pCR rate of triple-negative breast cancer. The secondary outcome included genomics of plasma extracellular vesicles, plasma metabolites and metabolomics, urine metabolomics, fecal intestinal flora tests, pathological tissue genomics, functional assessment of cancer therapy breast (FACT-B), and adverse events.

Participants enrolled in this study will be randomized to xiaopi granules plus neoadjuvant chemotherapy, or xiaopi decoction plus neoadjuvant chemotherapy, or placebo plus neoadjuvant chemotherapy alone.

Researchers will compare the pathological complete response between xiaopi granules and decoction group, and to determine their effects in chemosensitizing triple-negative breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhiyu Wang

Criteria

Inclusion Criteria:

• Females aged ≥18 and ≤75 years

• Pathological diagnosis of triple-negative breast cancer with stage II-III

• Not having received any previous treatment for breast cancer

• Having at least one measurable tumor

• No distant metastases

• ECOG score 0-2

• Neoadjuvant chemotherapy or combination immunotherapy

• Agree to participate in this clinical study and sign the informed consent form

Exclusion Criteria:

• Pregnant and breastfeeding, with fertility requirements during the study period

• Combined other malignant tumors

• Combination of serious diseases of the heart, brain, liver, kidney, and hematopoietic system, liver function impairment, and diabetes mellitus

• Active hepatitis B virus or hepatitis C virus infection, or human immunodeficiency virus (HIV) infection

• Presence of factors affecting the administration and absorption of the drug

• Allergy to the drug components of this regimen

• A history of psychotropic substance abuse or drug use

• The patient has other life-threatening diseases

• Participating in other drug trials