Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358573
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC INVINCIBLE-4-SAKK
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer TNBC An Open-label Randomized Two-cohort Phase 2 Clinical Trial INVINCIBLE-4-SAKK
Status:
RECRUITING
Status Verified Date:
2024-09
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:
About 10-20 of all individuals with breast cancer have a so-called triple-negative tumor TNBC This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response pCR to treatment In the phase II study SAKK 6622 it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined
Detailed Description:
Triple-negative breast cancer TNBC poses significant challenges due to its aggressiveness high relapse rates and increased mortality The Keynote-522 study revealed a 196 incidence of event-free survival EFS events in early-stage TNBC patients over 39 months Achieving pathological complete response pCR and clearing positive lymph nodes are crucial prognostic factors
The IMP INT230-6 is a combination of the chemotherapeutic agents cisplatin and vinblastine along with a molecule that facilitates their distribution in tumor tissue INT230-6 currently in clinical trials has demonstrated the ability to induce up to 95 necrosis in T2 breast cancer tumors and it has been observed to stimulate systemic immune activation during the period between diagnosis and surgery Moreover promising results have been seen in seven refractory breast cancer patients resulting in decreased Ki67 levels and a median overall survival of 12 months
Completed and ongoing US clinical trials including 91 patient a window-of-opportunity trial demonstrate the safety and early activity of INT230-6 both alone and with checkpoint inhibitors like pembrolizumab and ipilimumab particularly in resistant cases
Based on the positive outcomes it will be assessed within this clinical trial the safety and early clinical activity of INT230-6 in early TNBC patients addressing the high unmet medical need in this challenging subtype
The IMP INT230-6 is a combination of the chemotherapeutic agents cisplatin and vinblastine along with a molecule that facilitates their distribution in tumor tissue INT230-6 currently in clinical trials has demonstrated the ability to induce up to 95 necrosis in T2 breast cancer tumors and it has been observed to stimulate systemic immune activation during the period between diagnosis and surgery Moreover promising results have been seen in seven refractory breast cancer patients resulting in decreased Ki67 levels and a median overall survival of 12 months
Completed and ongoing US clinical trials including 91 patient a window-of-opportunity trial demonstrate the safety and early activity of INT230-6 both alone and with checkpoint inhibitors like pembrolizumab and ipilimumab particularly in resistant cases
Based on the positive outcomes it will be assessed within this clinical trial the safety and early clinical activity of INT230-6 in early TNBC patients addressing the high unmet medical need in this challenging subtype
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?:
None