Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604858
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Phase II Study of Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer The TELESCOPE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELESCOPE
Brief Summary:
This is a single arm proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC tumor size 10 mm and up to 25 mm node-negative status by clinical exam and local radiological evaluation and who have not previously received chemotherapy targeted therapy andor radiotherapy for invasive breast cancer
Detailed Description:
After signing informed consent form ICF and confirmed eligibility eligible patients with localized TNBC node-negative status and who have not previously received chemotherapy targeted therapy andor radiotherapy for invasive breast cancer N30 will receive treatment with Pembrolizumab and Carboplatin plus Paclitaxel up to surgery as indicated below
Pembrolizumab 200 mg every three weeks Q3W intravenously IV on day 1 D1 of each cycle
Carboplatin area under the curve AUC 15 IV on D1 D8 and D15 of each 21-days cycle
Paclitaxel 80 mgm2 IV on D1 D8 and D15 of each 21-days cycle
The treatment is composed by 4 cycles of 21 days each patients will be treated for a total of 84 days and treatment will last until surgery
Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected until end of study EoS or study termination whichever occurs first
Pembrolizumab 200 mg every three weeks Q3W intravenously IV on day 1 D1 of each cycle
Carboplatin area under the curve AUC 15 IV on D1 D8 and D15 of each 21-days cycle
Paclitaxel 80 mgm2 IV on D1 D8 and D15 of each 21-days cycle
The treatment is composed by 4 cycles of 21 days each patients will be treated for a total of 84 days and treatment will last until surgery
Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected until end of study EoS or study termination whichever occurs first
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