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The I SPY 2.2 TRIAL: Evolving to Imaging and Molecular Biomarker Response Directed Adaptive Sequential Treatment to Optimize Breast Cancer Outcomes

Award Number: P01CA210961
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/08/2017
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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The I SPY 2.2 TRIAL: Evolving to Imaging and Molecular Biomarker Response Directed Adaptive Sequential Treatment to Optimize Breast Cancer Outcomes - The I-SPY Program Project advances the goals of personalized treatment in the setting of an advanced clinical trial design that facilitates continuous improvement in outcomes. In this program, we focus on women with stage 2 and 3 molecularly high-risk, early breast cancer who have the highest risk for rapid progression and death. The I-SPY2.2 program project allows us to generate a patient-centric approach to clinical drug development that optimizes individual, biomarker- targeted treatments by escalation or de-escalation of therapy based on treatment response, doing so in the context of a trial that efficiently evaluates novel potential first-line agents and treatment regimens. The lessons and insights developed in this program project will be broadly applicable beyond breast cancer to other cancers and to clinical trial design. The continuation of the I-SPY2.2 program project will provide the resources for the discovery research that ultimately will increase complete response (pCR) and prevent metastases. The proposed four projects and three shared resource cores will allow us to create strategies for combining multiple biomarker analytes from the tumor and derivatives assessed in circulation to build better and better predictive models of lack of response and poor outcome in the neoadjuvant setting and further identify ‘druggable’ targets in residual disease to alleviate resistance. The I-SPY program and the Program Project have, in effect, established a continuous improvement system for breast cancer treatment outcomes, enabling us to drive progress in precision medicine for breast cancer, importantly, using a highly patient-centric framework. The iterative process will lead to more and better targeting of therapies by leveraging biologic insights, refinement of response- predictive biomarkers, and integration of both efficacy and impact on quality of life. The combination of these elements will save lives, reduce morbidity and set the stage for improved personalization and translation to clinical practice. In the past 5 years of the I-SPY2.2 program project, we have met all of our stated aims, creating and implementing (June 2022) a novel, innovative trial design to both test novel agents and individualize care over the course of the treatment. In the subsequent five years, we will iteratively refine the processes to optimize outcomes through early de-escalation of treatment in the setting of success, and early escalation of treatment in the setting of minimal response, based on our innovations in establishing and refining quantitative breast MRI as a biomarker of response assessment. We will use integrated molecular and immune response-predictive subtypes developed in the first five years to assign treatments for targeted agents initially without standard chemotherapeutics, but then in sequence if response is not sufficient. We will randomize treatments based on the improved, response-predicted subtypes we developed to test their ability to precisely assign treatments. We will use a sequential multiple assignment approach (SMART) to identify optimal sequences of therapy and use the framework to integrate a seamless phase 2/3 trial that will speed the process of getting the most effective, least toxic treatment strategies to women in the shortest possible time. The infrastructure of the proposed program project and the tightly integrated, experienced multidisciplinary team that is dedicated to the goals of the program will enable us to accomplish our goals and impact the lives of women with high-risk breast cancer.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $2,372,773 )
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	9	7/8/2026	NON-COMPETING CONTINUATION	$2,372,773
														Subtotal = $2,372,773

Issue Date FY: 2025 ( Subtotal = $2,747,550 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	8	7/11/2025	NON-COMPETING CONTINUATION	$2,747,550
														Subtotal = $2,747,550

Issue Date FY: 2024 ( Subtotal = $2,641,849 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	002	7	6/25/2024	NON-COMPETING CONTINUATION	$2,641,849
2024	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	001	6	6/21/2024	COMPETING CONTINUATION	$4,105
2024	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	5	6/21/2024	NON-COMPETING CONTINUATION	-$4,105
														Subtotal = $2,641,849

Issue Date FY: 2023 ( Subtotal = $2,689,478 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	001	6	7/3/2023	COMPETING CONTINUATION	$2,689,478
2023	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	5	6/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,689,478

Issue Date FY: 2021 ( Subtotal = $1,800,771 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	5	8/6/2021	NON-COMPETING CONTINUATION	$1,800,771
														Subtotal = $1,800,771

Issue Date FY: 2020 ( Subtotal = $1,845,433 )
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	4	8/28/2020	NON-COMPETING CONTINUATION	$1,845,433
														Subtotal = $1,845,433

Issue Date FY: 2019 ( Subtotal = $1,954,475 )
2019	2019	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	3	9/9/2019	NON-COMPETING CONTINUATION	$1,954,475
														Subtotal = $1,954,475

Issue Date FY: 2018 ( Subtotal = $2,124,555 )
2018	2018	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	2	9/20/2018	NON-COMPETING CONTINUATION	$2,124,555
														Subtotal = $2,124,555

Issue Date FY: 2017 ( Subtotal = $2,339,503 )
2017	2017	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 420	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	1	9/7/2017	NEW	$2,339,503
														Subtotal = $2,339,503

Grand Total All Awards = $20,516,387

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The I SPY 2.2 TRIAL: Evolving to Imaging and Molecular Biomarker Response Directed Adaptive Sequential Treatment to Optimize Breast Cancer Outcomes

Award Number: P01CA210961

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/08/2017

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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