OncoMatch/Clinical Trials/NCT01042379
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Is NCT01042379 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for breast neoplasms.
Treatment: Standard Therapy · 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 · 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 · Zanidatamab · Lasofoxifene · Z-endoxifen · ARV-471 · ARV-471 + Letrozole · ARV-471 + Abemaciclib · Endoxifen + Abemaciclib · Rilvegostomig + TDXd · Dan222 + Niraparib · Sarilumab + Cemiplimab + Paclitaxel · GSK 5733584 · GSK 5733584 + Dostarlimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Sarcoma
Triple-Negative Breast Cancer
Disease stage
Required: Stage II, III, T4, ANY N, M0, REGIONAL STAGE IV (SUPRACLAVICULAR LYMPH NODES ONLY)
Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Cannot have received: radiation therapy
Lab requirements
Blood counts
Leukocytes ≥ 3000/μL, Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 100,000/μL
Kidney function
creatinine < 1.5 x institutional ULN
Liver function
Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN
Cardiac function
No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%
Normal organ and marrow function: Leukocytes ≥ 3000/μL, Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 100,000/μL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN; No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Mayo Clinic - Scottsdale · Scottsdale, Arizona
- University of Arizona · Tucson, Arizona
- University of California - Davis, Comprehensive Cancer Center · Davis, California
- City of Hope · Duarte, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT01042379 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage II or III or T4, ANY N, M0 or REGIONAL STAGE IV (SUPRACLAVICULAR LYMPH NODES ONLY) is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages