Breast CancerNCT05914753
Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
A study testing Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel and Epirubicin, Cyclophosphamide, Docetaxel in people with Breast Cancer and Chemotherapy Effect, run by Zhejiang Provincial People's Hospital.
Trial summary
Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy Effect
- What is being tested?
- Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel and Epirubicin, Cyclophosphamide, Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jun 2025
- Phase
- Interventional
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy of breast mass was performed under ultrasound-guided treatment before neoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmed pathologically, followed by immunohistochemical examination. Pathological sections before and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more senior pathologists, and there were consistent definite conclusions.
- Have detailed and complete clinicopathological data;
- Diagnosis data of TCM syndrome type;
- No biopsy-confirmed lymph node metastasis;
- No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment;
- At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery;
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- Under the guidance of doctors, take Xihuang pills in a standardized way throughout the whole process and review regularly;
- The patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy;
- All patients were newly diagnosed
Who cannot join
- Concurrent malignant tumors of other sites;
- Patients with distant metastasis
- Male breast cancer
- Patients who did not receive full-course standardized neoadjuvant chemotherapy;
- Lost contact or dropped out of the study, unable to follow up;
- Inability to tolerate chemotherapy responses;
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- Intolerant to Xihuang Wan and unable to take it;
- The patient has strong side effects of chemotherapy and cannot tolerate chemotherapy drugs;
- Inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer;
- Various other possible influences.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer
Read the detailed description
- To evaluate the safety and effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer under the condition of widespread use.
- To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.
- Conditions
- Breast Cancer, Chemotherapy Effect
- Being tested
- Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel, Epirubicin, Cyclophosphamide, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirubicin, Cyclophosphamide, Xihuang Pill, DocetaxelDrug
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles
Epirubicin, Cyclophosphamide, DocetaxelDrug
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles Receives: Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel |
| Control group | Placebo comparator | Control group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles Receives: Drug: Epirubicin, Cyclophosphamide, Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
Pathological complete response
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuli Meng, Zhejiang Provincial People's Hospital
- Investigators
- Xuli Meng, Study chair, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914753
- Sponsor's protocol ID
- XHWBC
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After preliminary results are available, it is advisable to decide whether to share them with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT05914753
- Acronym / sponsor ID
- XHWBC
- Conditions
- Breast Cancer, Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 22 Jun 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.
Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer
Detailed description
- To evaluate the safety and effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer under the condition of widespread use.
- To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, DocetaxelExperimental group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles |
| Control group | Placebo comparator | Drug: Epirubicin, Cyclophosphamide, DocetaxelControl group: Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy of breast mass was performed under ultrasound-guided treatment before neoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmed pathologically, followed by immunohistochemical examination. Pathological sections before and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more senior pathologists, and there were consistent definite conclusions.
- Have detailed and complete clinicopathological data;
- Diagnosis data of TCM syndrome type;
- No biopsy-confirmed lymph node metastasis;
- No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment;
Key exclusion criteria (10 listed)
- Concurrent malignant tumors of other sites;
- Patients with distant metastasis
- Male breast cancer
- Patients who did not receive full-course standardized neoadjuvant chemotherapy;
- Lost contact or dropped out of the study, unable to follow up;
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 |
|---|---|---|
| Epirubicin, Cyclophosphamide, Xihuang Pill, DocetaxelEpirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles | Drug | Experimental group |
| Epirubicin, Cyclophosphamide, DocetaxelEpirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles | Drug | Control group |
Primary outcome
Pathological complete response (pCR)
Time frame: six months
Pathological complete response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No. After preliminary results are available, it is advisable to decide whether to share them with other researchers.
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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.
Xuli Meng study chair
Zhejiang Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel and Epirubicin, Cyclophosphamide, Docetaxel in people with Breast Cancer and Chemotherapy Effect, run by Zhejiang Provincial People's Hospital.
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 9 inclusion and 10 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 22 Jun 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.
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 Hongchao Tang (+8613282037232, thc0571@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.