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

Launched by ZHIYU WANG · Nov 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different forms of a treatment called Xiaopi in women with triple-negative breast cancer, which is a type of breast cancer that does not respond to certain hormones. The researchers want to find out if Xiaopi granules or a liquid version called decoction, when combined with standard chemotherapy, can help improve the chances of patients having no visible cancer after treatment. Participants will be divided into three groups: one will receive Xiaopi granules with chemotherapy, another will receive the decoction with chemotherapy, and the third will receive a placebo (a treatment that has no active ingredients) with chemotherapy.

To be eligible for this trial, participants must be female, aged between 18 and 75, and have been diagnosed with stage II or III triple-negative breast cancer that has not been treated before. They should have at least one measurable tumor and no spread of cancer to other parts of the body. Participants will need to agree to be part of the study and sign a consent form. Throughout the trial, researchers will monitor how well the treatments work and check for any side effects. It’s important for potential participants to understand that they will receive either the Xiaopi treatment or a placebo alongside their chemotherapy, and they will be part of a study that could help improve treatments for future patients.

Gender

FEMALE

Eligibility criteria

• 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