Ignite Creation Date:
2024-05-05 @ 10:59 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01220128
Status:
TERMINATED
Last Update Posted:
2021-05-25
First Post:
2010-10-07
Brief Title:
Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study of GSK2302024A Antigen-Specific Cancer Immunotherapeutic Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study termination due to negative Ph III of another study product from same technology platform
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDUCT
Brief Summary:
The purpose of this study is to evaluate the safety immunogenicity and clinical activity of a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast cancer The treatment will be given before surgery in combination with standard therapy
Detailed Description:
The study will be conducted in two consecutive segments Phase I and Phase II each with specific objectives Active follow-up will be for three years
Patients in this study will be allocated to cohorts as below Cohort A will include postmenopausal patients with hormone receptor-positive breast cancer who receive aromatase inhibitor AI as neoadjuvant therapy concurrently with administration of 6 or 8 doses of WT1 anti-cancer immunotherapy WT1 ASCIplacebo starting on Day 0 AI treatment will be administered daily for duration of either 18 if 6 doses of WT1 ASCIplacebo or 24 weeks if 8 doses of WT1 ASCIplacebo
Cohort B will include breast cancer patients who will receive neoadjuvant chemotherapy concurrently with administration of WT1 ASCIplacebo starting on Day 0 Neoadjuvant chemotherapy in Cohort B will consist either 1 if 6 doses of WT1 ASCIplacebo 6 cycle-treatment chemotherapy regimens consist of 6 three-weekly cycles of anthracyclinetaxane-based therapy or 2 if 8 doses of WT1 ASCIplacebo 8 cycle-treatment regimens consisting of 4 three-weekly cycles of anthracycline-based therapy followed by 4 three-weekly or 12-weekly taxane administrations without trastuzumab
Cohort C will include patients with Human Epidermal Growth Factor Receptor 2 HER2-overexpressing breast cancer who will receive neoadjuvant trastuzumab Herceptin therapy combined with chemotherapy concurrently with administration of WT1 ASCIplacebo starting on Day 0 Neoadjuvant chemotherapy in Cohort C will consist either 1 if 6 doses of WT1 ASCIplacebo 6 cycle-treatment chemotherapy regimens consist of 6 three-weekly cycles of anthracyclinetaxane-based therapy or 2 if 8 doses of WT1 ASCIplacebo 8 cycle-treatment regimens consisting of 4 three-weekly cycles of anthracycline-based therapy followed by 4 three-weekly or 12-weekly taxane administrations with trastuzumab
Cohorts D and E will include patients with hormone receptor-positive and HER2 non-overexpressing breast cancer who will receive neoadjuvant chemotherapy For patients in these Cohorts D and E WT1 ASCIplacebo placebo applicable only for Cohort E patients will be administered on Day 14 of each three-weekly cycle of chemotherapy Neoadjuvant chemotherapy in Cohorts D and E will consist either 1 if 6 doses of WT1 ASCIplacebo 6 cycle-treatment chemotherapy regimens consist of 6 three-weekly cycles of anthracyclinetaxane-based therapy or 2 if 8 doses of WT1 ASCIplacebo 8 cycle-treatment regimens consisting of 4 three-weekly cycles of anthracycline-based therapy followed by 4 three-weekly taxane administrations without trastuzumab Enrolment in Cohort E will be conditional on the absence of a safety signal and on the adequate induction of an immune response by the WT1 ASCI in Cohort D defined as 40 response rate based on post-Dose 4 anti-WT1 antibody responses in at least six patients If this criterion is met 60 patients 40 receiving WT1 ASCI and 20 placebo with identical eligibility criteria will be enrolled into Cohort E In case no adequate safety andor immunogenicity will be obtained in Cohort D recruitment in Cohort E will not be initiated
The protocol has been updated following Protocol Amendment 4 April 2013 leading to the update of the study design
Patients in this study will be allocated to cohorts as below Cohort A will include postmenopausal patients with hormone receptor-positive breast cancer who receive aromatase inhibitor AI as neoadjuvant therapy concurrently with administration of 6 or 8 doses of WT1 anti-cancer immunotherapy WT1 ASCIplacebo starting on Day 0 AI treatment will be administered daily for duration of either 18 if 6 doses of WT1 ASCIplacebo or 24 weeks if 8 doses of WT1 ASCIplacebo
Cohort B will include breast cancer patients who will receive neoadjuvant chemotherapy concurrently with administration of WT1 ASCIplacebo starting on Day 0 Neoadjuvant chemotherapy in Cohort B will consist either 1 if 6 doses of WT1 ASCIplacebo 6 cycle-treatment chemotherapy regimens consist of 6 three-weekly cycles of anthracyclinetaxane-based therapy or 2 if 8 doses of WT1 ASCIplacebo 8 cycle-treatment regimens consisting of 4 three-weekly cycles of anthracycline-based therapy followed by 4 three-weekly or 12-weekly taxane administrations without trastuzumab
Cohort C will include patients with Human Epidermal Growth Factor Receptor 2 HER2-overexpressing breast cancer who will receive neoadjuvant trastuzumab Herceptin therapy combined with chemotherapy concurrently with administration of WT1 ASCIplacebo starting on Day 0 Neoadjuvant chemotherapy in Cohort C will consist either 1 if 6 doses of WT1 ASCIplacebo 6 cycle-treatment chemotherapy regimens consist of 6 three-weekly cycles of anthracyclinetaxane-based therapy or 2 if 8 doses of WT1 ASCIplacebo 8 cycle-treatment regimens consisting of 4 three-weekly cycles of anthracycline-based therapy followed by 4 three-weekly or 12-weekly taxane administrations with trastuzumab
Cohorts D and E will include patients with hormone receptor-positive and HER2 non-overexpressing breast cancer who will receive neoadjuvant chemotherapy For patients in these Cohorts D and E WT1 ASCIplacebo placebo applicable only for Cohort E patients will be administered on Day 14 of each three-weekly cycle of chemotherapy Neoadjuvant chemotherapy in Cohorts D and E will consist either 1 if 6 doses of WT1 ASCIplacebo 6 cycle-treatment chemotherapy regimens consist of 6 three-weekly cycles of anthracyclinetaxane-based therapy or 2 if 8 doses of WT1 ASCIplacebo 8 cycle-treatment regimens consisting of 4 three-weekly cycles of anthracycline-based therapy followed by 4 three-weekly taxane administrations without trastuzumab Enrolment in Cohort E will be conditional on the absence of a safety signal and on the adequate induction of an immune response by the WT1 ASCI in Cohort D defined as 40 response rate based on post-Dose 4 anti-WT1 antibody responses in at least six patients If this criterion is met 60 patients 40 receiving WT1 ASCI and 20 placebo with identical eligibility criteria will be enrolled into Cohort E In case no adequate safety andor immunogenicity will be obtained in Cohort D recruitment in Cohort E will not be initiated
The protocol has been updated following Protocol Amendment 4 April 2013 leading to the update of the study design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2010-019909-42 | EUDRACT_NUMBER | None | None |