Comparative efficacy of XIAOPI Granules and decoction in improving pathological complete response of neoadjuvant chemotherapy of triple-negative breast cancer: a randomized controlled trial

Mechanism of therapeutic effect of XIAOPI formula combined with neoadjuvant chemotherapy in clearing death-released signal CXCL1exo to improve the immune suppression microenvironment in triple-negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400079422

Enrollment

Unknown

Registered

2024-01-03

Start date

2024-01-15

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-negative breast cancer

Interventions

Experimental group:Xiaopi granules plus neoadjuvant chemotherapy

Experimental group:Xiaopi decoction plus neoadjuvant chemotherapy

Control group:Placebo plus neoadjuvant chemotherapy

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Females aged =18 and =75 years ; 2. Pathological diagnosis of triple-negative breast cancer with stage II-III; 3. Not having received any previous treatment for breast cancer; 4. Having at least one measurable tumor; 5. No distant metastases; 6. ECOG score 0-2; 7. Neoadjuvant chemotherapy or combination immunotherapy; 8. Agree to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Pregnant and breastfeeding, with fertility requirements during the study period 2.Combined other malignant tumors 3.Combination of serious diseases of the heart, brain, liver, kidney, and hematopoietic system, liver function impairment, and diabetes mellitus 4. Active hepatitis B virus or hepatitis C virus infection, or human immunodeficiency virus (HIV) infection 5. Presence of factors affecting the administration and absorption of the drug 6. Allergy to the drug components of this regimen 7. A history of psychotropic substance abuse or drug use 8. The patient has other life-threatening diseases 9. Participating in other drug trials

Design outcomes

Primary

Measure	Time frame
Pathological complete response (pCR) ;	—

Secondary

Measure	Time frame
Response Evaluation Criteria In Solid Tumors;Genomics of plasma extracellular vesicles;Plasma Metabolites and Metabolomics;Urine Metabolomics;Fecal Intestinal Flora Tests;Pathological Tissue Genomics;Functional Assessment of Cancer Therapy-Breast;Adverse events;	—

Countries

China

Contacts

Public ContactZhiyu Wang

Guangdong Provincial Hospital of Traditional Chinese Medicine

wangzhiyu@gzucm.edu.cn+86 188 1948 0766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026