# Core 02 - Statistics and Bioinformatics

> **NIH NIH P01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $234,963

## Abstract

SUMMARY CORE 2
This Program Project comprises four individual projects, which will: implement evidence-based sequential
multiple treatment assignment strategies for patients predicted to have insufficient response to their initial
neoadjuvant targeted and/or chemotherapy (Project 1); qualify non-invasive imaging methods as early markers
of non-response (Project 2); characterize the biology of non-responders to inform treatment selection (Project
3); and develop a portfolio of agents and decision tools for treatment re-assignment matched to biology of non-
responding tumors (Project 4). The Bioinformatics and Statistics Core will act as a centralized resource where
the analytical goals of these projects converge - where we work closely with each of the project groups not only
to provide project-specific analytical support, but also to build predictive models across multiple modalities
(imaging, molecular profiles and their combination) and facilitate cross-project interactions towards the
common goal of building robust decision algorithms to enable adaptation of treatment for individual women
with poor response to their initial neoadjuvant targeted and/or chemotherapy. This undertaking will utilize
substantial the archived and newly generated datasets from the I-SPY 1 and I-SPY 2 trials to develop and
validate algorithms that will enable the transition to I-SPY 2+, where patients predicted as insufficient
responders by an optimized, subtype-specific MRI-based predictor “Virtual RCB” can be identified during the
course of their initial therapy (after completion of their taxol +/- experimental agent and 2 cycles of AC) and
offered alternative treatment strategies based on their tumor biology in order to mitigate recurrence and
improve long term outcomes.
The primary goal of the Biostatistics and Bioinformatics Core is to provide biostatistics and bioinformatics
support to individual projects and facilitate cross-project analyses and results sharing within the Program
Project Framework. The specific aims are listed as follows:
Specific Aim 1: To provide innovative bioinformatics and statistical modeling and analytical approaches
needed by the projects to achieve their Specific Aims.
Specific Aim 2: To develop SMART (sequential, multiple assignment, randomized trial) methods for adaptive
treatment of predicted non-responders within the I-SPY 2+ Program Project framework.
Specific Aim 3: To synthesize biomarker data within and across projects into actionable clinical information.

## Key facts

- **NIH application ID:** 10249160
- **Project number:** 5P01CA210961-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** DONALD A BERRY
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $234,963
- **Award type:** 5
- **Project period:** 2017-09-08 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10249160

## Citation

> US National Institutes of Health, RePORTER application 10249160, Core 02 - Statistics and Bioinformatics (5P01CA210961-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10249160. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*