Clinical Trial: NCT01042379
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Status:
RECRUITINGPhase:
Phase 2| Lead Sponsor: | QuantumLeap Healthcare Collaborative |
| Information Provided By: | QuantumLeap Healthcare Collaborative |
| Last Update Posted: | 2026-05-06 |
Study Overview
Brief 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)
Conditions
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
Intervention / Treatment
- Drug: Standard Therapy
- Drug: AMG 386 with or without Trastuzumab
- Drug: AMG 479 (Ganitumab) plus Metformin
- Drug: MK-2206 with or without Trastuzumab
- Drug: AMG 386 and Trastuzumab
- Drug: T-DM1 and Pertuzumab
- Drug: Pertuzumab and Trastuzumab
- Drug: Ganetespib
- Drug: ABT-888
- Drug: Neratinib
- Drug: PLX3397
- Drug: Pembrolizumab - 4 cycle
- Drug: Talazoparib plus Irinotecan
- Drug: Patritumab and Trastuzumab
- Drug: Pembrolizumab - 8 cycle
- Drug: SGN-LIV1A
- Drug: Durvalumab plus Olaparib
- Drug: SD-101 + Pembrolizumab
- Drug: Tucatinib plus trastuzumab and pertuzumab
- Drug: Cemiplimab
- Drug: Cemiplimab plus REGN3767
- Drug: Trilaciclib with or without trastuzumab + pertuzumab
- Drug: SYD985 ([vic-]trastuzumab duocarmazine)
- Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab
- Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
- Drug: Amcenestrant
- Drug: Amcenestrant + Abemaciclib
- Drug: Amcenestrant + Letrozole
- Drug: ARX788
- Drug: ARX788 + Cemiplimab
- Drug: VV1 + Cemiplimab
- Drug: Datopotamab deruxtecan
- Drug: Datopotamab deruxtecan + Durvalumab
- Drug: Zanidatamab
- Drug: Lasofoxifene
- Drug: Z-endoxifen
- Drug: ARV-471
- Drug: ARV-471 + Letrozole
- Drug: ARV-471 + Abemaciclib
- Drug: Endoxifen + Abemaciclib
- Drug: Rilvegostomig + TDXd
- Drug: Dan222 + Niraparib
- Drug: Sarilumab + Cemiplimab + Paclitaxel
- Drug: GSK 5733584
- Drug: GSK 5733584 + Dostarlimab
- Drug: Ivonescimab (20mg/kg Q3W)
Other Study ID Numbers
- 097517
Start Date (Actual)
2010-03-01
Primary Completion Date (Estimated)
2030-12
Study Completion Date (Estimated)
2031-12
Enrollment (Estimated)
5000
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | QuantumLeap Healthcare Collaborative |
| Information Provided By: | QuantumLeap Healthcare Collaborative |
| Last Update Posted: | 2026-05-06 |
Study Overview
Brief 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)
Conditions
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
Intervention / Treatment
- Drug: Standard Therapy
- Drug: AMG 386 with or without Trastuzumab
- Drug: AMG 479 (Ganitumab) plus Metformin
- Drug: MK-2206 with or without Trastuzumab
- Drug: AMG 386 and Trastuzumab
- Drug: T-DM1 and Pertuzumab
- Drug: Pertuzumab and Trastuzumab
- Drug: Ganetespib
- Drug: ABT-888
- Drug: Neratinib
- Drug: PLX3397
- Drug: Pembrolizumab - 4 cycle
- Drug: Talazoparib plus Irinotecan
- Drug: Patritumab and Trastuzumab
- Drug: Pembrolizumab - 8 cycle
- Drug: SGN-LIV1A
- Drug: Durvalumab plus Olaparib
- Drug: SD-101 + Pembrolizumab
- Drug: Tucatinib plus trastuzumab and pertuzumab
- Drug: Cemiplimab
- Drug: Cemiplimab plus REGN3767
- Drug: Trilaciclib with or without trastuzumab + pertuzumab
- Drug: SYD985 ([vic-]trastuzumab duocarmazine)
- Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab
- Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
- Drug: Amcenestrant
- Drug: Amcenestrant + Abemaciclib
- Drug: Amcenestrant + Letrozole
- Drug: ARX788
- Drug: ARX788 + Cemiplimab
- Drug: VV1 + Cemiplimab
- Drug: Datopotamab deruxtecan
- Drug: Datopotamab deruxtecan + Durvalumab
- Drug: Zanidatamab
- Drug: Lasofoxifene
- Drug: Z-endoxifen
- Drug: ARV-471
- Drug: ARV-471 + Letrozole
- Drug: ARV-471 + Abemaciclib
- Drug: Endoxifen + Abemaciclib
- Drug: Rilvegostomig + TDXd
- Drug: Dan222 + Niraparib
- Drug: Sarilumab + Cemiplimab + Paclitaxel
- Drug: GSK 5733584
- Drug: GSK 5733584 + Dostarlimab
- Drug: Ivonescimab (20mg/kg Q3W)
Other Study ID Numbers
- 097517
Start Date (Actual)
2010-03-01
Primary Completion Date (Estimated)
2030-12
Study Completion Date (Estimated)
2031-12
Enrollment (Estimated)
5000
Study Type
Interventional
Phase
Phase 2