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Personalized treatment for breast cancer using new drug agents

I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

PHASE2 · QuantumLeap Healthcare Collaborative · NCT01042379

This study is testing new drug combinations with standard chemotherapy to see which treatments work best for different types of breast cancer based on the specific characteristics of each patient's tumor.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment5000 (estimated)
Ages18 Years and up
SexAll
SponsorQuantumLeap Healthcare Collaborative (other)
Drugs / interventionschemotherapy, radiation
Locations42 sites (Birmingham, Alabama and 41 other locations)
Trial IDNCT01042379 on ClinicalTrials.gov

What this trial studies

The I-SPY2 trial aims to enhance personalized medicine by identifying which novel drug agents are most effective for different types of breast cancer tumors. It evaluates the efficacy of these agents in combination with standard chemotherapy, focusing on subsets of patients based on their tumor's molecular characteristics. The study utilizes tumor analysis through MRI, along with tissue and blood samples, to predict treatment success and adaptively modify treatment strategies based on real-time data. Treatments that demonstrate low efficacy will be dropped, while promising new drugs will be introduced as they complete evaluation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed invasive breast cancer and measurable disease.

Not a fit: Patients who have previously undergone chemotherapy or radiation therapy for breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to more effective, personalized treatment options for patients with breast cancer.

How similar studies have performed: Other adaptive trials have shown success in personalizing cancer treatment, indicating a promising approach for this study.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Birmingham, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.