Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT04498793
Status:
UNKNOWN
Last Update Posted:
2020-09-03
First Post:
2020-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Study of Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as Perioperative Treatment in Participants With HER2 Negative Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of tislelizumab plus chemotherapy vs chemotherapy alone as perioperative treatment in participants who have triple negative HER2 negative breast cancer.
After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Tislelizumab + Chemotherapy OR Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment.
After definitive surgery, each participant will receive adjuvant study treatment (routine adjuvant treatment +/- Tislelizumab) for approximately 42 weeks (14 cycles).
Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.
After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Tislelizumab + Chemotherapy OR Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment.
After definitive surgery, each participant will receive adjuvant study treatment (routine adjuvant treatment +/- Tislelizumab) for approximately 42 weeks (14 cycles).
Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: