Breast cancer
Conditions
Interventions
Experimental group:Yi'ai Fuzheng No.II Decoction (twice a day, 100 mL each time) + conventional radiotherapy or/and chemotherapy
Control group:Conventional radiotherapy or/and chemotherapy
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: All of the following criteria are met for inclusion 1) All are primary triple negative breast cancer and are diagnosed by pathology or cytology; 2) 18 years old = age = 70 years; 3) Patients with advanced triple negative breast cancer and with tumor metastasis, relapse or irregularities; 4) In order to facilitate observation, at least one lesion can be measured; 5) There are no serious organic or functional disorders such as heart, liver, kidney, brain, etc., without drugs and food allergies; 6) KPS score =70 points; 7) The expected life span =12 weeks; 8) Take effective contraceptive measures; 9) Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: If the subject meets any of the following conditions will be exclusived 1) Do not meet the criteria of Inclusion; 2) It is known that those who are allergic to the component of medication in the study, or subject with allergies; 3) Starting from the opinions of researchers, some obvious diseases have excluded patients outside this study (for example: patients with irresistible diabetes or hypertension, patients with severe heart or lung disease); 4) Women who are in breastfeeding, pregnancy, or positive blood/urine pregnancy test; 5) Medical or psychological status does not allow patients to complete this study or signed an informed consent form; 6) Patients with other tumor history, in addition to those not recurred for more than 5 years; 7) Those who have mental illness affecting treament and follow-up compliance; 8) Participate in other clinical drug trial within 3 months before the study; 9) Researchers believe that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;One-year survival rate;Overall survival;Traditional Chinese Medicine Syndrome Score;Life status assessment (KPS score); | — |
Countries
China
Contacts
Public ContactYingwen Zhang
Zhongnan Hospital of Wuhan University
Outcome results
None listed