A preliminary investigation on the efficacy and mechanism of postoperative application of Sophora granules in triple-negative breast cancer patients

Phase 4

Recruiting

• Conditions: Triple negative breast cancer

• Registration Number: ITMCTR2100004579
• Lead Sponsor: Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who have undergone modified radical mastectomy or breast-conserving surgery for triple-negative breast cancer;
2. Aged 18 and 80 years;
3. have completed postoperative adjuvant chemotherapy and are on a first-line regimen (AT/TAC), and have not received chemotherapy or breast cancer-related medications within 1 month;
4. do not have significant cardiopulmonary or renal insufficiency;
5. Barthel Index score > 70.

Exclusion Criteria

1. Combination of other malignant tumors, other autoimmune related diseases and endocrine diseases;
2. Patients with unclear pathological diagnosis or those who do not meet the staging of the group to which they belong;
3. Patients with significant cardiac, hepatic, renal, cerebral, neurological or hematopoietic dysfunction;
4. Women who are pregnant, lactating or preparing for pregnancy;
5. Patients with allergies or known hypersensitivity to therapeutic agents or components;
6. Patients with known distant metastases or recurrence;
7. Patients who are participating in other clinical drug trials;
8. Patients with a Barthel Index score <=60 on the daily living ability scale.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum tumor markers;mtor;blood test;