I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2
To determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin, and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature.
• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
• other medical or mental health diagnosis that would limit compliance with study requirements
Drug: ABT-888, Drug: AMG 386 and Trastuzumab, Drug: AMG 386 with or without Trastuzumab, Drug: AMG 479 (Ganitumab) plus Metformin, Drug: ARV-471, Drug: ARV-471 + Abemaciclib, Drug: ARV-471 + Letrozole, Drug: ARX788, Drug: ARX788 + Cemiplimab, Drug: Amcenestrant, Drug: Amcenestrant + Abemaciclib, Drug: Amcenestrant + Letrozole, Drug: Cemiplimab, Drug: Cemiplimab plus REGN3767, Drug: Dan222 + Niraparib, Drug: Datopotamab deruxtecan, Drug: Datopotamab deruxtecan + Durvalumab, Drug: Durvalumab plus Olaparib, Drug: Endoxifen + Abemaciclib, Drug: Ganetespib, Drug: Lasofoxifene, Drug: MK-2206 with or without Trastuzumab, Drug: Neratinib, Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Drug: PLX3397, Drug: Patritumab and Trastuzumab, Drug: Pembrolizumab - 4 cycle, Drug: Pembrolizumab - 8 cycle, Drug: Pertuzumab and Trastuzumab, Drug: Rilvegostomig + TDXd, Drug: SD-101 + Pembrolizumab, Drug: SGN-LIV1A, Drug: SYD985 ([vic-]trastuzumab duocarmazine), Drug: Sarilumab + Cemiplimab + Paclitaxel, Drug: Standard Therapy, Drug: T-DM1 and Pertuzumab, Drug: Talazoparib plus Irinotecan, Drug: Trilaciclib with or without trastuzumab + pertuzumab, Drug: Tucatinib plus trastuzumab and pertuzumab, Drug: VV1 + Cemiplimab, Drug: Z-endoxifen, Drug: Zanidatamab
Cancer
Clinics and Surgery Center (CSC), Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2