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

November 22, 2023 updated by: Zhiyu Wang

Comparative Efficacy of Xiaopi Granules and Decoction in Improving Pathological Complete Response of Neoadjuvant Chemotherapy of Triple-negative Breast Cancer: a Randomized, Double-blind, Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Triple-negative breast cancers (TNBCs) are characterized by poor prognosis, rapid progression to metastatic stage, and onset of resistance to chemotherapy. Neoadjuvant chemotherapy is commonly used to improve the surgical pathological complete response rate (pCR) in stage II-III triple-negative breast cancer. However, chemotherapy can lead to immune escape and drug resistance in breast cancer cells, while the toxic side effects significantly affect patients' quality of life. The combination of Chinese herbal medicine and chemotherapy can improve survival rates while alleviating chemotherapy-related adverse events. Xiaopi Granules were developed by Professor Lin Yi, a renowned Traditional Chinese Medicine doctor in the field of breast diseases. The investigators' preliminary research has confirmed that Xiaopi Granules can inhibit tumor progression by targeting TAMs/CXCL1 signaling to suppress chemotherapy-induced autophagy, as well as inhibit the formation of tumor stem cells and pre-metastatic niches. Chinese medicine granules not only have several advantages compared to decoction, such as reliable drug quality and convenient administration but also have the characteristics of individualized prescription. However, whether their efficacy is comparable to that of the decoction granules still requires exploration. The investigators aimed to compare the efficacy of xiaopi granules and decoction in improving the pathological complete response of neoadjuvant chemotherapy of triple-negative breast cancer.

Hypothesis: Xiaopi granules can improve the pathological complete response of neoadjuvant chemotherapy of triple-negative breast cancer.

Patients and methods: Ninety patients with TNBC will be enrolled in this study and randomized to xiaopi granules plus neoadjuvant chemotherapy, xiaopi decoction plus neoadjuvant chemotherapy, or placebo plus neoadjuvant chemotherapy. The primary aim is the rate of pathological complete response (pCR, defined as the absence of invasive cells in breast and lymph nodes). 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 safety( AE and SAE). The neoadjuvant chemotherapy is carried out based on the National Comprehensive Cancer Network (NCCN) guidelines. Different treatments and doses are set according to the standard recommendations outlined in the guidelines. In addition to receiving neoadjuvant chemotherapy, the participants will be subjected to Xiaopi granules or decoction orally at a dosage of 18g per bag, 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. A placebo is a look-alike substance that contains no active drug.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xiaopi granules plus neoadjuvant chemotherapy
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 granules (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course.
Other Names:
  • Xiaopi formula
Experimental: Xiaopi decoction plus neoadjuvant chemotherapy
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
Xiaopi decoction (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course.
Other Names:
  • Xiaopi formula
Placebo Comparator: Placebo plus neoadjuvant chemotherapy
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
The placebo does not contain any active pharmaceutical ingredients .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response
Time Frame: Through study completion,an average of 6 moths
Defined as the absence of invasive cells in breast and lymph nodes.
Through study completion,an average of 6 moths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame: Through study completion, an average of 6 moths
The RECIST 1.1 version is used as the standard for evaluating the clinical efficacy of solid tumors.
Through study completion, an average of 6 moths
Genomics of plasma extracellular vesicles
Time Frame: Through study completion, an average of 6 moths
Extracellular vesicles were isolated from the plasma of breast cancer patients using a differential ultracentrifugation method. High-throughput whole transcriptome sequencing was conducted to identify differentially expressed genes in the isolated extracellular vesicles. The primary experimental procedures for transcriptome sequencing analysis include RNA quantification and qualification, library preparation for transcriptome sequencing, clustering and sequencing, and data analysis. . Analysis of whole transcriptome microarray data was performed using BioConductor software based on the statistical R programming language.
Through study completion, an average of 6 moths
Plasma Genomic Tests
Time Frame: Through study completion, an average of 6 moths
Utilize the Ultimate U3000 HPLC (Thermo Fisher Scientific) coupled to Q Exactive Plus mass spec- trometer (Thermo Fisher Scientific) to detect differences in metabolites within the blood of different medication intervention treatment groups before and after medication.All data were acquired and analyzed with the Xcalibur 4.0 software (Thermo Fisher Scientific).
Through study completion, an average of 6 moths
Urine Metabolomics Tests
Time Frame: Through study completion, an average of 6 moths
Utilize the Vanquish ultra-high-performance liquid chromatography-mass spectrometry system (Thermo Fisher Scientific) to detect variations in metabolites within the urine of different medication intervention treatment groups before and after medication.All data were acquired and analyzed with the Xcalibur 4.0 software (Thermo Fisher Scientific).
Through study completion, an average of 6 moths
Fecal Intestinal Flora Tests
Time Frame: Through study completion, an average of 6 moths
Laboratory testing for differences in faecal intestinal flora testing before and after the patient's medication.
Through study completion, an average of 6 moths
Pathological Tissue Genomics Tests
Time Frame: Through study completion, an average of 6 moths
Using whole exome sequencing (WES) to perform high-throughput sequencing of the exonic regions in pathological tissues, thereby detecting mutations, insertions, or deletions within genes. Furthermore, utilize the Genome Analysis Toolkit (GATK) software package to analyze the genomic sequencing data.
Through study completion, an average of 6 moths
Functional Assessment of Cancer Therapy-Breast
Time Frame: Through study completion, an average of 6 moths
Utilize the FACT-B questionnaire to evaluate the quality of life of breast cancer patients in different medication intervention treatment groups before and after treatment. This questionnaire comprehensively assesses patients' performance in social interactions, emotional experiences, daily functioning, and physical condition, which indirectly reflects their overall quality of life.
Through study completion, an average of 6 moths
Safety assessments
Time Frame: Through study completion, an average of 6 moths
Evaluate to adverse events and serious adverse events.
Through study completion, an average of 6 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhiyu Wang

Investigators

  • Study Chair: Zhiyu Wang, PhD, Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 25, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Estimated)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangdongXPRCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Firstly, sharing IPD could potentially lead to the identification of individual participants, breaching their privacy rights. It is crucial to prioritize the protection of personal information and ensure that participants' identities remain confidential. Secondly, participants trust that their data will be used responsibly and for the intended purpose of the study. Sharing IPD without their explicit consent may go against ethical guidelines and compromise the trust between researchers and participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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