I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

a study on Breast Cancer Breast Tumor

Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
Laura Esserman, MD, MBA

Description

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.

Official Title

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

Details

I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show a high Bayesian predictive probability of being more effective than standard therapy will graduate from the trial with their corresponding biomarker signature(s). Regimens will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.

Keywords

Breast Neoplasms Breast Cancer Breast Tumors I-SPY 2 Neoadjuvant Breast Cancer Neoplasm Adaptive pCR Pathologic Complete Response Biomarkers signature MRI Volume Metformin Paclitaxel Ado-trastuzumab emtansine Albumin-Bound Paclitaxel Cyclophosphamide Pembrolizumab Doxorubicin Liposomal doxorubicin Irinotecan Trastuzumab Durvalumab Olaparib Pertuzumab Veliparib Talazoparib Trebananib AMG 386 with or without Trastuzumab AMG 479 (Ganitumab) plus Metformin MK-2206 with or without Trastuzumab AMG 386 and Trastuzumab T-DM1 and Pertuzumab Pertuzumab and Trastuzumab Ganetespib ABT-888 Neratinib PLX3397 Pembrolizumab - 4 cycle Talazoparib plus Irinotecan Patritumab and Trastuzumab Pembrolizumab - 8 cycle SGN-LIV1A Durvalumab plus Olaparib SD-101 + Pembrolizumab Tucatinib AMG 479 plus Metformin Pembrolizumab 4 cycle Pembrolizumab 8 cycle

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco (UCSF) accepting new patients
    San Francisco California 94115 United States
  • University of Southern California in progress, not accepting new patients
    Los Angeles California 90033 United States

Lead Scientist

  • Laura Esserman, MD, MBA
    Dr. Laura Esserman, M.D., M.B.A is a surgeon and breast cancer oncology specialist practicing at the UCSF Carol Franc Buck Breast Care Center where she has also held the position of Director since 1996. She co-leads the Breast Oncology Program, the largest of the UCSF Helen Diller Comprehensive Cancer Center's multidisciplinary programs.

Details

Status
accepting new patients
Start Date
Sponsor
QuantumLeap Healthcare Collaborative
Links
I-SPY 2 TRIAL Website
Abstract S5-02 SABCC 2014
Abstract CT227 AACR 2014
Abstract P1-14-03; SABCC 2015
ID
NCT01042379
Phase
Phase 2
Study Type
Interventional
Last Updated