Triple Negative Breast NeoplasmsPhase 2NCT06154109
Comparative Efficacy of Xiaopi Granules and Decoction in Triple-negative Breast Cancer: a Randomized Controlled Trial
A Phase 2 study testing Xiaopi granules and Xiaopi decoction in people with Triple Negative Breast Neoplasms, run by Zhiyu Wang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple Negative Breast Neoplasms
- What is being tested?
- Xiaopi granules and Xiaopi decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2023to 30 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- A history of psychotropic substance abuse or drug use
- The patient has other life-threatening diseases
- Participating in other drug trials
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Triple Negative Breast Neoplasms
- Being tested
- Xiaopi granules, Xiaopi decoction, Placebo
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaopi granulesDrug
Also called Xiaopi formula
Xiaopi granules (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course.
Xiaopi decoctionDrug
Also called Xiaopi formula
Xiaopi decoction (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course.
PlaceboDrug
The placebo does not contain any active pharmaceutical ingredients .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Defined as the absence of invasive cells in breast and lymph nodes.
Measured: Through study completion,an average of 6 moths
Secondary outcomes (8)
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
The RECIST 1.1 version is used as the standard for evaluating the clinical efficacy of solid tumors.
Measured: Through study completion, an average of 6 moths
Genomics of plasma extracellular vesicles
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.
Measured: Through study completion, an average of 6 moths
Plasma Genomic Tests
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).
Measured: Through study completion, an average of 6 moths
Urine Metabolomics Tests
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).
Measured: Through study completion, an average of 6 moths
Fecal Intestinal Flora Tests
Laboratory testing for differences in faecal intestinal flora testing before and after the patient's medication.
Measured: Through study completion, an average of 6 moths
Pathological Tissue Genomics Tests
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.
Measured: Through study completion, an average of 6 moths
Functional Assessment of Cancer Therapy-Breast
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.
Measured: Through study completion, an average of 6 moths
Safety assessments
Evaluate to adverse events and serious adverse events.
Measured: Through study completion, an average of 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start25 Nov 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiyu Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Zhiyu Wang, PhD, Study chair, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154109
- Sponsor's protocol ID
- GuangdongXPRCT
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 21067385Nedeljkovic 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.
PubMed 31443516Park 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.
PubMed 33268821Mehraj 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.
PubMed 33420940Shree 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.
PubMed 22156207Shi 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.
PubMed 34164318Wang 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.
PubMed 31803057Wang 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.
PubMed 31629951Zheng 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.
PubMed 32213179
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06154109
- Acronym / sponsor ID
- GuangdongXPRCT
- Conditions
- Triple Negative Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhiyu WangUniversity, hospital or other
- Study start
- 25 Nov 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xiaopi granules plus neoadjuvant chemotherapy | Experimental | Drug: Xiaopi granulesXiaopi 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. |
| Xiaopi decoction plus neoadjuvant chemotherapy | Experimental | Drug: Xiaopi decoctionXiaopi 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. |
| Placebo plus neoadjuvant chemotherapy | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaopi granulesAlso: Xiaopi formulaXiaopi granules (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course. | Drug | Xiaopi granules plus neoadjuvant chemotherapy |
| Xiaopi decoctionAlso: Xiaopi formulaXiaopi decoction (18 g/ bag), 18 g/ time, 2 times/day, 8 days/course. | Drug | Xiaopi decoction plus neoadjuvant chemotherapy |
| PlaceboThe placebo does not contain any active pharmaceutical ingredients . | Drug | Placebo plus neoadjuvant chemotherapy |
Primary outcome
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.
8 secondary outcomes
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Through study completion, an average of 6 moths
Genomics of plasma extracellular vesicles
Time frame: Through study completion, an average of 6 moths
Plasma Genomic Tests
Time frame: Through study completion, an average of 6 moths
Urine Metabolomics Tests
Time frame: Through study completion, an average of 6 moths
Fecal Intestinal Flora Tests
Time frame: Through study completion, an average of 6 moths
Pathological Tissue Genomics Tests
Time frame: Through study completion, an average of 6 moths
Functional Assessment of Cancer Therapy-Breast
Time frame: Through study completion, an average of 6 moths
Safety assessments
Time frame: Through study completion, an average of 6 moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 21067385Foulkes 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.
- Background: PubMed 31443516Nedeljkovic 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.
- Background: PubMed 33268821Park 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.
- Background: PubMed 33420940Mehraj 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.
- Background: PubMed 22156207Shree 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.
- Background: PubMed 34164318Shi 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.
- Background: PubMed 31803057Wang 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.
- Background: PubMed 31629951Wang 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.
- Background: PubMed 32213179Zheng 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiyu Wang, PhD study chair
Guangdong Provincial Hospital of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xiaopi granules and Xiaopi decoction in people with Triple Negative Breast Neoplasms, run by Zhiyu Wang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyu Wang, PhD (+8618819480766, wangzhiyu@gzucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: Through study completion,an average of 6 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06154109, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.