I-SPY Trial: New and Personalized Treatments for Breast Cancer Before Surgery

Sponsor: QuantumLeap Healthcare Collaborative

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01042379

Provider View

This study aims to improve personalized medicine by finding out which new drugs work best for different types of breast cancer. It also looks at early signs that might predict how well a treatment will work, using MRI scans and samples from the tumor and blood.

Patient Parameters

Program Overview

The I-SPY Trial is designed to test new drugs in combination with standard chemotherapy to find the best treatment strategies for different types of breast cancer. The study focuses on understanding which drugs are most effective for specific molecular characteristics of the cancer. By analyzing early indicators like MRI images and tissue samples, researchers hope to predict treatment success. New drugs will be tested as they become available, and those that show promise will continue in the trial.

Description

The I-SPY2 trial evaluates the effectiveness of new drugs used alongside standard chemotherapy to treat breast cancer. The goal is to identify the best treatment strategies based on the molecular characteristics of the cancer, known as biomarker signatures. Drugs that show high effectiveness will be further developed, while those with low effectiveness will be discontinued. The trial is adaptive, meaning it can change as new information becomes available, allowing new drugs to be tested as they are developed.

Eligibility Criteria

Inclusion Criteria

  • Confirmed invasive breast cancer.
  • Tumor in the breast that can be measured and is at least 2.5 cm in size.
  • No previous chemotherapy or radiation for this cancer, but bis-phosphonate therapy is allowed.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Willing to have a biopsy of the breast tumor to check for specific markers.
  • Not pregnant or breastfeeding.
  • No metal implants that are not MRI-compatible.
  • Able to understand and sign a consent form.
  • Tumor must be at Stage II or III, or specific other stages as defined.
  • Any hormone receptor status or HER-2/neu status.
  • Normal organ and bone marrow function as shown by specific blood tests.
  • No severe heart disease, with a heart function of at least 50%.
  • No signs of cancer spread to distant organs.
  • Tumor must meet specific profile criteria, such as MammaPrint High or Low with certain hormone receptor and HER2 statuses.

Exclusion Criteria

  • Use of other experimental drugs within 30 days before starting the study.
  • Allergic reactions to similar drugs or supportive medications.
  • Uncontrolled health issues like ongoing infections, heart failure, unstable chest pain, irregular heartbeats, or psychiatric conditions that could affect participation in the study.

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