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

NCT ID: NCT06154109

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-25

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Triple Negative Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Xiaopi granules

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Xiaopi decoction

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo does not contain any active pharmaceutical ingredients .

Interventions

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Xiaopi granules

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

Intervention Type DRUG

Xiaopi decoction

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

Intervention Type DRUG

Placebo

The placebo does not contain any active pharmaceutical ingredients .

Intervention Type DRUG

Other Intervention Names

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Xiaopi formula Xiaopi formula

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhiyu Wang

OTHER

Sponsor Role lead

Responsible Party

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Zhiyu Wang

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhiyu Wang, PhD

Role: STUDY_CHAIR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Central Contacts

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Zhiyu Wang, PhD

Role: CONTACT

Phone: +8618819480766

Email: [email protected]

Jian Luo, PhD

Role: CONTACT

Phone: +8615270247376

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 21067385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31443516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33268821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33420940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22156207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34164318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31803057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31629951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32213179 (View on PubMed)

Other Identifiers

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GuangdongXPRCT

Identifier Type: -

Identifier Source: org_study_id