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Flexible versus Standard Aerobic Training Dosing in Primary Breast Cancer: A Randomized and Response-Adapted Trial

Award Number: R01CA272733
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/21/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Flexible versus Standard Aerobic Training Dosing in Primary Breast Cancer: A Randomized and Response-Adapted Trial - PROJECT SUMMARY/ABSTRACT Chemotherapy for primary breast cancer causes significant declines in cardiorespiratory fitness (CRF) predisposing patients to increased symptom burden and increased risk of morbidity and mortality from cancer and non-cancer conditions. Randomized trials demonstrate aerobic training (AT) is feasible during chemotherapy for primary breast cancer and attenuates treatment-induced impairments in CRF. However, our recent findings indicate that even with AT during and after chemotherapy, CRF remains substantially below normative values, and less than 25% of patients have a clinically meaningful CRF response. Increasing the dose of AT substantially increases CRF response; however, higher AT doses are associated with lower AT adherence. Thus, use of a conventional dose-response design wherein patients are assigned to fixed doses is likely imprudent considering lower fixed AT doses will result in underdosing in some patients, and poor adherence in others. A more patient- centered approach used in drug trials is flexible dosing, where the dose is escalated for each patient as tolerated. There have been no trials directly assessing the efficacy of flexible AT dosing on CRF in any cancer setting. To address this fundamental knowledge gap in exercise-oncology research, the objective of this study is to compare the effects of flexible versus standard fixed AT dosing and response-adapted AT on CRF response. In this randomized trial, a total of 140 inactive (<90 mins of moderate-intensity exercise/wk) patients with primary breast cancer scheduled to initiate chemotherapy will be randomly allocated (1:1) to Flexible dosing: Individual AT doses escalated; or Standard fixed dosing: 90 mins/week for ~32 weeks (during and after chemotherapy). Patients who do not respond (<3.50 ml/kg/min CRF improvement) at 32 weeks will complete 20 weeks of extended flexible dosing AT. We will address 3 specific aims: AIM 1: Compare the effects of flexible versus standard dosing on CRF response rate. AIM 2: Ascertain the effects on adherence, safety, and patient-reported outcomes. AIM 3: Evaluate the effects of extended AT in CRF non-responders. IMPACT: This study challenges the current dogma that all patients respond equally to a fixed AT dose and will be the first to evaluate flexible AT dosing in any cancer population. Receiving cancer treatment is not a qualifying condition for structured AT and, as such, AT is not currently considered a standard aspect of cancer management. We anticipate the proposed trial will directly address an unmet clinical need by identifying the AT regimen that maximizes CRF response rate and, if successful, findings from this investigation will help guide the AT regimen for translation to clinical care.


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 = $0 )
2026	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	3	12/30/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $1,952,296 )
2025	2025	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	001	4	8/26/2025	EXTENSION WITH OR WITHOUT FUNDS	$1,442,297
2025	2025	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	002	4	9/4/2025	SUPPLEMENT FOR EXPANSION	$509,999
2025	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	3	8/25/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,952,296

Issue Date FY: 2024 ( Subtotal = $686,954 )
2024	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	3	8/15/2024	NON-COMPETING CONTINUATION	$686,954
														Subtotal = $686,954

Issue Date FY: 2023 ( Subtotal = $708,646 )
2023	2023	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVENUE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	001	2	8/30/2023	NON-COMPETING CONTINUATION	$708,646
2023	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	1	11/2/2022	NEW	$0
														Subtotal = $708,646

Issue Date FY: 2022 ( Subtotal = $734,548 )
2022	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Detection and Diagnosis Research	000	1	9/21/2022	NEW	$734,548
														Subtotal = $734,548

Grand Total All Awards = $4,082,444

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Flexible versus Standard Aerobic Training Dosing in Primary Breast Cancer: A Randomized and Response-Adapted Trial

Award Number: R01CA272733

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/21/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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