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PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial

Recruiting

This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
Exclusion Criteria:

• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms

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 + Letrozole, Drug: ARX788, Drug: ARX788 + Cemiplimab, Drug: Amcenestrant, Drug: Amcenestrant + Abemaciclib, Drug: Amcenestrant + Letrozole, Drug: Cemiplimab, Drug: Cemiplimab plus REGN3767, Drug: Datopotamab deruxtecan, Drug: Datopotamab deruxtecan + Durvalumab, Drug: Durvalumab plus Olaparib, 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: SD-101 + Pembrolizumab, Drug: SGN-LIV1A, Drug: SYD985 ([vic-]trastuzumab duocarmazine), 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, Women's Health

Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY

David Potter - dapotter@umn.edu
David Potter
PHASE2
SITE00001846
See this study on ClinicalTrials.gov

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