I-SPY TRIAL: Personalized Treatments for Breast Cancer
This study, called I-SPY, is looking for better ways to treat breast cancer by personalizing treatment. It tests new drugs alongside standard chemotherapy (like Paclitaxel, Doxorubicin, and Cyclophosphamide) to see which ones work best for different types of breast cancer. The goal is to find out if adding these new drugs increases the chance of a complete response (pathologic complete response or pCR), meaning no cancer cells are found after surgery. You might be able to join if you have invasive breast cancer that can be measured and haven't had prior chemotherapy for this cancer. The study is ongoing, but some drug arms, like those testing AMG 386, AMG 479 (Ganitumab) plus Metformin, and MK-2206, are now closed.
- Study design
- This is an interventional study with a planned enrollment of 5000 participants. It aims to identify effective treatment strategies based on the molecular characteristics of breast cancer.
- What's involved
- You would receive 12 weekly treatments of Paclitaxel, followed by Doxorubicin and Cyclophosphamide for weeks 13-16, all before surgery. Tumor analysis via MRI images, tissue, and blood samples would also be part of the process.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, pathologic complete response, is measured after surgery, based on up to 36 weeks of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT01042379
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentQuantumLeap Healthcare CollaborativeInvestigator-initiated
~5,000 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Standard TherapyAMG 386 with or without TrastuzumabAMG 479 (Ganitumab) plus MetforminMK-2206 with or without TrastuzumabAMG 386 and TrastuzumabT-DM1 and Pertuzumab
At a glance
Recruiting sites
32 of 42 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.
Measured over Post surgery based on upto 36-week treatment
Conditions
Where it's being run
42 sites across 24 statesCalifornia6
New York5
Minnesota3
Arizona2
Florida2
Illinois2
Ohio2
Pennsylvania2
Study leadership
- Laura Esserman, MD, MBA · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed invasive cancer of the breast
Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
Age ≥18 years
ECOG performance status 0-1
Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
Non-pregnant and non-lactating
No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
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
Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F
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%
No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase
Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™)
Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)
Exclusion
Use of any other investigational agents within 30 days of starting study treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
What this trial measures
- Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.Post surgery based on upto 36-week treatment