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Status unknownNCT05914753Updated Jun 22, 2023

Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer

An interventional study of Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel and Epirubicin, Cyclophosphamide, Docetaxel in Breast Cancer and Chemotherapy Effect, sponsored by Zhejiang Provincial People's Hospital. Status unknown. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Zhejiang Provincial People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer

Read the detailed description
  1. 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.
  2. To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.
02

Conditions studied

  • Breast Cancer
  • Chemotherapy Effect

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03

In context

Breast Neoplasms

12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Zhejiang Provincial People's Hospital is the lead sponsor of 61 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Have detailed and complete clinicopathological data;
  3. Diagnosis data of TCM syndrome type;
  4. No biopsy-confirmed lymph node metastasis;
  5. No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment;
  6. At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery;
  7. Under the guidance of doctors, take Xihuang pills in a standardized way throughout the whole process and review regularly;
  8. The patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy;
  9. All patients were newly diagnosed

Exclusion criteria

Exclusion Criteria:

  1. Concurrent malignant tumors of other sites;
  2. Patients with distant metastasis
  3. Male breast cancer
  4. Patients who did not receive full-course standardized neoadjuvant chemotherapy;
  5. Lost contact or dropped out of the study, unable to follow up;
  6. Inability to tolerate chemotherapy responses;
  7. Intolerant to Xihuang Wan and unable to take it;
  8. The patient has strong side effects of chemotherapy and cannot tolerate chemotherapy drugs;
  9. Inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer;
  10. Various other possible influences.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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

    Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel

  • Placebo comparator
    Control group

    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

    Drug: Epirubicin, Cyclophosphamide, Docetaxel

Interventions

  • DrugEpirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel

    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

  • DrugEpirubicin, Cyclophosphamide, Docetaxel

    Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles

06

What researchers measure

Primary outcomes

  1. Pathological complete response (pCR)

    Pathological complete response

    Time frame: six months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — After preliminary results are available, it is advisable to decide whether to share them with other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2023; primary completion for Jun 2024, 11 months later.

Of 2,274 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 11 months is below that.

Counting every sponsor, half of 2,347 studies reached it within 34 months; a quarter within 16 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2023
First posted
Jun 22, 2023
StartEst.
Jul 1, 2023
Primary completionEst.
Jun 1, 2024
CompletionEst.
Jun 1, 2025
Last update
Jun 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05914753
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Xuli Meng (Chief physician, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
Jun 22, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Jun 22, 2023

Study contacts

Hongchao Tang
Contact
thc0571@live.com
+8613282037232
Xuli Meng
study chair · Zhejiang Provincial People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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