Ignite Creation Date:
2024-05-06 @ 12:17 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03725059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2018-10-29
Brief Title:
Study of Pembrolizumab MK-3475 Versus Placebo in Combination With Neoadjuvant Chemotherapy Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative ERHER2- Breast Cancer MK-3475-756KEYNOTE-756
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Double-Blind Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative ERHER2- Breast Cancer KEYNOTE-756
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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 assess the efficacy and safety of pembrolizumab MK-3475 versus placebo in combination with neoadjuvant pre-surgery chemotherapy and adjuvant post-surgery endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive human epidermal growth factor receptor 2-negative ERHER2- breast cancer
The primary study hypotheses are 1 pembrolizumab is superior to placebo both in combination with the protocol-specified neoadjuvant anticancer therapy as assessed by pathological Complete Response pCR rate defined by the local pathologist and 2 pembrolizumab is superior to placebo both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies as assessed by Event-Free Survival EFS as determined by the investigator The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR ypT0Tis ypN0 or EFS
The primary study hypotheses are 1 pembrolizumab is superior to placebo both in combination with the protocol-specified neoadjuvant anticancer therapy as assessed by pathological Complete Response pCR rate defined by the local pathologist and 2 pembrolizumab is superior to placebo both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies as assessed by Event-Free Survival EFS as determined by the investigator The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR ypT0Tis ypN0 or EFS
Detailed Description:
Study participants will receive 8 cycles of neoadjuvant study treatment and then will undergo surgery for their breast cancer After surgery participants will receive 9 cycles of study treatment and up to 10 years of variable endocrine therapy Each cycle is 21 days long
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004869-27 | EUDRACT_NUMBER | jRCT | None |
| MK-3475-756 | OTHER | None | None |
| 194604 | REGISTRY | None | None |
| KEYNOTE-756 | OTHER | None | None |
| 2023-506921-12 | OTHER | None | None |
| jRCT2080224535 | OTHER | None | None |