# I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

> **NCT01042379** · PHASE2 · RECRUITING · sponsor: **QuantumLeap Healthcare Collaborative** · enrollment: 5000 (estimated)

## Conditions studied

- 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

## Interventions

- **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

## Key facts

- **NCT ID:** NCT01042379
- **Lead sponsor:** QuantumLeap Healthcare Collaborative
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2010-03-01
- **Primary completion:** 2030-12
- **Final completion:** 2031-12
- **Target enrollment:** 5000 (ESTIMATED)
- **Last updated:** 2026-05-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01042379

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01042379, "I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01042379. Licensed CC0.

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