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Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer

StatusRecruiting
PhasePhase 4
Started2021-06-18
View on ClinicalTrials.gov ↗

Amendment history

2024-06-25
3 amendments v7-v9
3 re-verifications since 2023-08-29, no change to tracked fields
2023-05-16
Study Status, Contacts/Locations v6
Study sites30→34
2022-12-21
Study Status, Contacts/Locations v5
Study sites19→30
2022-06-26
Study Status v4
Re-verified, no change to tracked fields
2022-02-21
Study Status, Contacts/Locations v3
Study sites1→19
Show 2 earlier versions
2021-07-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-05-14→confirmed 2021-06-18
Study sites1 entry, revised
ZhiminFudan ShaoUniversity Shanghai Cancer Center
2021-03-14
Study Status, Study Description, Outcome Measures v1
Secondary endpoints8 entries, revised
Changes in qualityEuropean Organization for Research and Treatment of lifeCancer scoreCore Quality of Life Questionnaire
Study description-4 characters
[...] rse events among operable patients with TNBC. In this study, we planned to enroll 1072 high-risk early-stage triple-negative invasive ductal [...] and 536 cases in the control group) from 30 research centers will be included. The block randomization was adopted, participants will be [...]
2021-03-05
Original filing
This is a prospective, multicenter, randomized, parallel controlled, open-label study. The primary purpose of this study is to evaluate the efficacy of Huaier Granule on postoperative adjuvant therapy of high-risk early-stage triple-negative invasive ductal carcinoma. The Secondary purposes are to evaluate the safety of long-term use of Huaier granules as postoperative adjuvant treatment of high-risk early-stage triple-negative invasive ductal carcinoma, and the changes of quality of life score after treatment with Huaier granule.
Trial Details
NCT Number NCT04790305
Lead Sponsor Fudan University
Collaborators: LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
Conditions Carcinoma Breast, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast
Enrollment 1,072 participants
Start Date 2021-06-18
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-07-28 (estimated)
Updated on ClinicalTrials.gov 2024-06-27