Huaier Granule in Treating Women With Triple Negative Breast Cancer

Launched by SHANDONG UNIVERSITY · Nov 24, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a traditional Chinese medicine called Huaier Granule in treating women with triple negative breast cancer, which is a type of breast cancer that doesn’t respond to some common treatments. The goal is to see if Huaier Granule can help prevent the cancer from coming back after surgery. The study is currently recruiting women aged 18 to 75 who have had their triple negative breast cancer surgically removed and have been cleared for participation based on their health tests.

Participants in this trial will take Huaier Granule and will be monitored for both its effectiveness and safety. To be eligible, women must meet certain health criteria, such as having good liver and kidney function and not being pregnant or breastfeeding. Those with advanced cancer or other serious health issues may not qualify. This trial offers an opportunity for women with this specific type of breast cancer to explore a new treatment option that may help improve their recovery.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age: ≥ 18 and ≤ 75 years, female;
• • Triple negative breast cancer has been surgically removed;
• • The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
• • Not receiving any preoperative anticancer drugs;
• • The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
• • Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \> 1.5×109/L;
• • The expected survival time ≥ 6 months;
• • The subjects volunteer to sign the informed consent.
• Exclusion Criteria:
• • Patients with stage IV breast cancer;
• • Triple negative breast cancer was not surgically removed;
• • Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
• • Pregnant or lactating women;
• • Those with active bleeding due to various reasons;
• • Those with HIV infection or AIDS-associated diseases;
• • Those with severe acute and chronic diseases;
• • Those with severe diabetes;
• • Those with serious infectious diseases;
• • Those who can not take drugs by oral route;
• • Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
• • Conditions that are considered not suitable for this study investigators