Status:
NOT_YET_RECRUITING
Comparative Efficacy of Xiaopi Granules and Decoction in Triple-negative Breast Cancer: a Randomized Controlled Trial
Lead Sponsor:
Zhiyu Wang
Conditions:
Triple Negative Breast Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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 ...
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 comm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06154109
Start Date
November 25 2023
End Date
March 30 2026
Last Update
December 1 2023
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