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

NCT06154109 | Not Yet Recruiting Phase 2

• 1 other identifier: GuangdongXPRCT
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Triple Negative Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  Defined as the absence of invasive cells in breast and lymph nodes.

  Through study completion,an average of 6 moths

Secondary Outcomes (8)

• Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  Through study completion, an average of 6 moths

• Genomics of plasma extracellular vesicles

  Through study completion, an average of 6 moths

• Plasma Genomic Tests

  Through study completion, an average of 6 moths

• Urine Metabolomics Tests

  Through study completion, an average of 6 moths

• Fecal Intestinal Flora Tests

  Through study completion, an average of 6 moths

Study Arms (3)

Xiaopi granules plus neoadjuvant chemotherapy

EXPERIMENTAL

Xiaopi granules have a dosage of 18 g per bag, 18 g per administration, twice daily, for a total of 8 days per treatment course. The duration of the treatment course will align with that of the chemotherapy regimen. The neoadjuvant chemotherapy is developed based on the National Comprehensive Cancer Network (NCCN) guidelines. Different treatments and doses are according to the standard recommendations outlined in the guidelines. Treatment options may include AC-T, ECT, EC, TC, AC, TAC, TP, etc.

Drug: Xiaopi granules

Xiaopi decoction plus neoadjuvant chemotherapy

EXPERIMENTAL

Xiaopi decoction has a dosage of 18 g per bag, 18 g per administration, twice daily, for a total of 8 days per treatment course. The duration of the treatment course will align with that of the chemotherapy regimen. The neoadjuvant chemotherapy is developed based on the National Comprehensive Cancer Network (NCCN) guidelines. Different treatments and doses are according to the standard recommendations outlined in the guidelines. Treatment options may include AC-T, ECT, EC, TC, AC, TAC, TP, etc.

Drug: Xiaopi decoction

Placebo plus neoadjuvant chemotherapy

PLACEBO COMPARATOR

The placebo is a look-alike substance that contains no active drug and has a placebo inspection report. The dosage of 18g per bag, 18g per administration, twice daily, for a total of 8 days per treatment course. The duration of the treatment course will align with that of the chemotherapy regimen. The neoadjuvant chemotherapy is developed based on the National Comprehensive Cancer Network (NCCN) guidelines. Different treatments and doses are according to the standard recommendations outlined in the guidelines. Treatment options may include AC-T, ECT, EC, TC, AC, TAC, TP, etc.

Drug: Placebo

Interventions

Xiaopi granules DRUG

Xiaopi granules (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course.

Also known as: Xiaopi formula

Xiaopi granules plus neoadjuvant chemotherapy

Xiaopi decoction DRUG

Xiaopi decoction (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course.

Also known as: Xiaopi formula

Xiaopi decoction plus neoadjuvant chemotherapy

Placebo DRUG

The placebo does not contain any active pharmaceutical ingredients .

Placebo plus neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhiyu Wang: lead

Related Publications (9)

• Foulkes WD, Smith IE, Reis-Filho JS. Triple-negative breast cancer. N Engl J Med. 2010 Nov 11;363(20):1938-48. doi: 10.1056/NEJMra1001389.

  PMID: 21067385 BACKGROUND

• Nedeljkovic M, Damjanovic A. Mechanisms of Chemotherapy Resistance in Triple-Negative Breast Cancer-How We Can Rise to the Challenge. Cells. 2019 Aug 22;8(9):957. doi: 10.3390/cells8090957.

  PMID: 31443516 BACKGROUND

• Park YH, Lal S, Lee JE, Choi YL, Wen J, Ram S, Ding Y, Lee SH, Powell E, Lee SK, Yu JH, Ching KA, Nam JY, Kim SW, Nam SJ, Kim JY, Cho SY, Park S, Kim J, Hwang S, Kim YJ, Bonato V, Fernandez D, Deng S, Wang S, Shin H, Kang ES, Park WY, Rejto PA, Bienkowska J, Kan Z. Chemotherapy induces dynamic immune responses in breast cancers that impact treatment outcome. Nat Commun. 2020 Dec 2;11(1):6175. doi: 10.1038/s41467-020-19933-0.

  PMID: 33268821 BACKGROUND

• Mehraj U, Dar AH, Wani NA, Mir MA. Tumor microenvironment promotes breast cancer chemoresistance. Cancer Chemother Pharmacol. 2021 Feb;87(2):147-158. doi: 10.1007/s00280-020-04222-w. Epub 2021 Jan 9.

  PMID: 33420940 BACKGROUND

• Shree T, Olson OC, Elie BT, Kester JC, Garfall AL, Simpson K, Bell-McGuinn KM, Zabor EC, Brogi E, Joyce JA. Macrophages and cathepsin proteases blunt chemotherapeutic response in breast cancer. Genes Dev. 2011 Dec 1;25(23):2465-79. doi: 10.1101/gad.180331.111.

  PMID: 22156207 BACKGROUND

• Shi G, Yu D, Wu J, Liu Y, Huang R, Zhang CS. A systematic review and meta-analysis of traditional Chinese medicine with chemotherapy in breast cancer. Gland Surg. 2021 May;10(5):1744-1755. doi: 10.21037/gs-21-284.

  PMID: 34164318 BACKGROUND

• Wang S, Liu X, Huang R, Zheng Y, Wang N, Yang B, Situ H, Lin Y, Wang Z. XIAOPI Formula Inhibits Breast Cancer Stem Cells via Suppressing Tumor-Associated Macrophages/C-X-C Motif Chemokine Ligand 1 Pathway. Front Pharmacol. 2019 Nov 15;10:1371. doi: 10.3389/fphar.2019.01371. eCollection 2019.

  PMID: 31803057 BACKGROUND

• Wang N, Yang B, Muhetaer G, Wang S, Zheng Y, Lu J, Li M, Zhang F, Situ H, Lin Y, Wang Z. XIAOPI formula promotes breast cancer chemosensitivity via inhibiting CXCL1/HMGB1-mediated autophagy. Biomed Pharmacother. 2019 Dec;120:109519. doi: 10.1016/j.biopha.2019.109519. Epub 2019 Oct 17.

  PMID: 31629951 BACKGROUND

• Zheng Y, Wang N, Wang S, Yang B, Situ H, Zhong L, Lin Y, Wang Z. XIAOPI formula inhibits the pre-metastatic niche formation in breast cancer via suppressing TAMs/CXCL1 signaling. Cell Commun Signal. 2020 Mar 26;18(1):48. doi: 10.1186/s12964-020-0520-6.

  PMID: 32213179 BACKGROUND

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhiyu Wang, PhD

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Zhiyu Wang, PhD

CONTACT

+8618819480766; wangzhiyu@gzucm.edu.cn

Jian Luo, PhD

CONTACT

+8615270247376; luojian1011@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: December 1, 2023
• Study Start: November 25, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share