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Clinical Trial 17268

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT01042379

Phase: Phase II
Prinicipal Investigator: Heather Han

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Study Title

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


This research study is a phase 2 study. A phase 2 study tests if an investigational drug, or combination of investigational drugs, works in a certain type of cancer and what side effects it has. This study is also being done to determine whether MRI scans can be routinely used in patients receiving neoadjuvant chemotherapy to predict (early in the course of treatment) which treatments will be most effective for patients with breast cancer.


Primary Objective: To determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin, and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature. Secondary Objectives: 1.2.1 Predictive and Prognostic Indices - To build predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB). 1.2.2 Biological Specimen Resource and Imaging Data Base - To initiate the creation of a Biological Specimen Repository, consisting of tumor tissue, RNA, DNA, serum, and cells, as well as corresponding magnetic resonance (MR) and pathology images of these specimens for ongoing translational studies in genomics, proteomics, and imaging in order to establish their relationship to overall survival (OS). 1.2.3 Relapse-free Survival - To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms. 1.2.4 Investigational Agent Safety - To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.




Inclusion Criteria

  • Women and men are eligible in this study.
  • Histologically confirmed cancer of the breast.
  • Clinically or radiologically measurable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm) across full extent of disease in at least one dimension. Longest diameter measurement on imaging for eligibility should span the full extent of disease, including intervening normal tissue and suspicious non-mass enhancement (NME) if disease is diffuse or multifocal. a tumor meets this criterion by clinical exam only, the tumor must also be ≥20 mm (2.0 cm) in at least one dimension when measured on conventional radiological imaging (PET, CT, MRI, ultrasound, or chest x-ray), or ≥10 mm (1.0 cm) with spiral CT.
  • No prior cytotoxic regimens are allowed for this malignancy. May not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
  • ECOG performance status 0-1
  • Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers. Patients are required to have a research core available in order to randomize.
  • Non-pregnant and non-breastfeeding. Documented negative serum or negative urine pregnancy tests within 14 days of randomization.
  • No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
  • 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
  • Normal organ and marrow function as defined per protocol.
  • 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
  • Tumor assay profile must include one of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (> Ability to understand and willingness to sign a written informed consent documents

  • 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
  • Additional criteria may apply

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