Clinical Trial 17268-B

• Overview

  Study Title:

  I-SPY 2.2 TRIAL - Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2

  Summary:

  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.

  Objective:

  Primary Objective To determine whether adding investigational agents to standard neoadjuvant paclitaxel (with or without trastuzumab), and/or doxorubicin and cyclophosphamide, increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone, 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. To determine whether investigational agents either alone or in sequence with best in class subtype specific chemotherapy combinations achieve a sufficiently high response rate, as measured by pCR and the probability of being superior, compared to a clinically determined fixed threshold (alone) or to the I-SPY 2.0 dynamic control (in sequence).

• Treatments

  Therapies:

  Chemotherapy (NOS); Hormonal Therapy; Immunotherapy; Therapy (NOS)

  Medications:

  AKTi (); AMP-514 (Durvalumab); ARV-471 (); ARX-788 (); Abemaciclib (); Adriamycin (doxorubicin); Cemiplimab (); Datopotamab Deruxtecan (); Durvalumab (); Femara (Letrozole); Herceptin (Trastuzumab); LY2835219 (Abemaciclib); Lasofoxifene (); Letrozole (); MEDI4736 (Durvalumab); PD-1 (); PD-L1 (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pertuzumab (); REGN2810 (Cemiplimab); Rilvegostomig (); T-Dxd (); Taxol (paclitaxel); Taxotere (docetaxel); Trastuzumab (); VV1 (); Z-endoxifen (); Zanidatamab (); carboplatin (); cyclophosphamide (); cytoxan (cyclophosphamide); docetaxel (); doxorubicin (); paclitaxel (); rhuMAb HER2 (Trastuzumab)

• 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 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 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 (> 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

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