Summary
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
Official Title
I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
Details
I-SPY2 will assess the efficacy of novel drugs in sequence with standard chemotherapy. The goal is identify treatment strategies for subsets on the basis of molecular characteristics (biomarker signatures) of their disease with high estimated pCR rate. As described for previous adaptive trials, novel regimens with sufficiently high activities alone and contribute to treatment strategies that show a high Bayesian predictive probability of being more effective than the dynamic control will graduate from the trial with their corresponding biomarker signature(s). Treatment strategies will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.
Keywords
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant, Breast, Cancer, Neoplasm, Adaptive, pCR, Pathologic Complete Response, Biomarkers signature, MRI Volume, Endocrine Therapy, Chemotherapy, Immunotherapy, Triple Negative Breast Neoplasms, Hemangiosarcoma, Metformin, Paclitaxel, Ado-Trastuzumab Emtansine, Albumin-Bound Paclitaxel, Carboplatin, Doxorubicin, Pembrolizumab, Trastuzumab, Irinotecan, Durvalumab, Letrozole, Olaparib, Pertuzumab, Veliparib, Cemiplimab, Talazoparib, Trebananib, Tucatinib, Monoclonal Antibodies, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab, AMG 386 and Trastuzumab, T-DM1 and Pertuzumab, Pertuzumab and Trastuzumab, Ganetespib, ABT-888, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, Amcenestrant + Abemaciclib, Amcenestrant + Letrozole, ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, Datopotamab deruxtecan, Datopotamab deruxtecan + Durvalumab, AMG 479 plus Metformin, Pembrolizumab 4 cycle, Pembrolizumab 8 cycle, Endocrine Optimization Pilot: Amcenestrant Monotherapy, Endocrine Optimization Pilot: Amcenestrant + Abemaciclib, Endocrine Optimization Pilot: Amcenestrant + Letrozole