For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Histologically confirmed invasive cancer of the breast
  2. Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
  3. 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
  4. Age ≥18 years
  5. ECOG performance status 0-1
  6. Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
  7. Non-pregnant and non-lactating
  8. No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
  9. Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
  10. 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
  11. 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
  12. 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
  13. No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%
  14. 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
  15. 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™)
  16. Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Use of any other investigational agents within 30 days of starting study treatment
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.
  3. 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
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (855) 866-0505Email iconEmail Study Center

Study Details


Contition

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

Age

18+

Phase

PHASE2

Participants Needed

5000

Est. Completion Date

Dec 31, 2031

Treatment Type

INTERVENTIONAL


Sponsor

QuantumLeap Healthcare Collaborative

ClinicalTrials.gov NCT Identifier

NCT01042379

Study Number

097517

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