Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT06604858
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 by mammogram and/or ultrasound, or ≤25 mm by breast MRI if performed within 2 weeks after biopsy, considering possible tissue inflammation post-procedure, as per local assessment), node-negative status (by clinical exam and local radiological evaluation) and who have not previously received chemotherapy, targeted therapy, and/or 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, and/or radiotherapy for invasive breast cancer (N=30) 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) 1.5, IV on D1, D8 and D15 of each 21-days cycle.
* Paclitaxel: 80 mg/m2, 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:
NCT06604858
Study Brief:
Protocol Section:
NCT06604858