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

Launched by QUANTUMLEAP HEALTHCARE COLLABORATIVE · Jan 4, 2010

Keywords

ClinConnect Summary

The I-SPY Trial is a research study aimed at finding out which new medications work best for different types of breast cancer. The goal is to personalize treatment by looking at how tumors respond to these drugs before surgery. Researchers will use MRI scans, along with tissue and blood samples, to learn more about early signs that can indicate whether the treatment is working.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of invasive breast cancer that has measurable disease. You should not have received prior chemotherapy or radiation for this type of cancer. Participants will undergo a core biopsy to check specific markers in the tumor and will be monitored closely throughout the study. It's important to note that the trial is currently recruiting participants, and everyone who joins will sign an informed consent form to ensure they understand the process and the study's requirements.

Gender

ALL

Eligibility 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