Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Exercise Treatment

About this trial

This is an interventional treatment trial for Hormone Receptor Positive Metastatic Breast Cancer focused on measuring Exercise, 19-113

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC)
Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression
Receiving first line endocrine-based therapy (tamoxifen, aromatase inhibitor, or fulvestrant; concurrent molecular therapy also allowed)
Sedentary (i.e., <60 minutes / week of exercise)
Age >18 years
BMI ≥ 18.5
Cleared for exercise participation as per screening clearance via PAR-Q+
Cleared for study participation as per screening consultation with an MSK Exercise Physiologist
Willingness to comply with all study-related procedures
Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled

Exclusion Criteria:

Life expectancy <6 months
Enrollment onto any other therapeutic investigational study
Mental impairment leading to inability to cooperate
Concurrent participation in weight loss or other exercise programs

Sites / Locations

Indiana University (Data Collection Only)Recruiting
Johns Hopkins Hospital (Data Collection Only)Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only)Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
Memorial Sloan Kettering Cancer CenterRecruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

aerobic training 90 mins/wk

aerobic training 150 mins/wk

aerobic training 225 mins/wk

aerobic training 300 mins/week

aerobic training 375 mins/week

Arm Description

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Outcomes

Primary Outcome Measures

maximum feasible dose (MFD)

Feasibility is defined in terms of the relative dose intensive (RDI), the proportion of the planned exercise prescription that was completed without requiring a dose modification or interruption. The MFD is defined as the dose estimated to result in approximately 70% of patients achieving an RDI ≥ 75%.

Secondary Outcome Measures

Full Information

NCT ID

NCT03988595

First Posted

June 13, 2019

Last Updated

September 18, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03988595

Brief Title

Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

Official Title

Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 12, 2019 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study will test any good and bad effects of aerobic exercise performed while you are receiving the usual first-line treatment for metastatic breast cancer. The researchers think that exercise helps delay the development of resistance to hormone therapy while slowing the growth of tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hormone Receptor Positive Metastatic Breast Cancer

Keywords

Exercise, 19-113

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Exercise therapy will consist of individualized walking delivered 3 to 5 times weekly for 24 weeks. This trial will evaluate four escalated doses of exercise (90 mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/week, or 375 mins/week).

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aerobic training 90 mins/wk

Arm Type

Experimental

Arm Description

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Arm Title

aerobic training 150 mins/wk

Arm Type

Experimental

Arm Description

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Arm Title

aerobic training 225 mins/wk

Arm Type

Experimental

Arm Description

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Arm Title

aerobic training 300 mins/week

Arm Type

Experimental

Arm Description

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Arm Title

aerobic training 375 mins/week

Arm Type

Experimental

Arm Description

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Intervention Type

Other

Intervention Name(s)

Exercise Treatment

Intervention Description

Exercise sessions will consist of individualized, walking delivered following a non-linear (i.e.,exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Primary Outcome Measure Information:

Title

maximum feasible dose (MFD)

Description

Feasibility is defined in terms of the relative dose intensive (RDI), the proportion of the planned exercise prescription that was completed without requiring a dose modification or interruption. The MFD is defined as the dose estimated to result in approximately 70% of patients achieving an RDI ≥ 75%.

Time Frame

24 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Breast Cancer

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC) Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression Receiving first line endocrine-based therapy (tamoxifen, aromatase inhibitor, or fulvestrant; concurrent molecular therapy also allowed) Sedentary (i.e., <60 minutes / week of exercise) Age >18 years BMI ≥ 18.5 Cleared for exercise participation as per screening clearance via PAR-Q+ Cleared for study participation as per screening consultation with an MSK Exercise Physiologist Willingness to comply with all study-related procedures Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled Exclusion Criteria: Life expectancy <6 months Enrollment onto any other therapeutic investigational study Mental impairment leading to inability to cooperate Concurrent participation in weight loss or other exercise programs

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Neil Iyengar, MD

Phone

646-888-4714

Email

iyengarn@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Lee Jones, PhD

Phone

646-888-8103

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University (Data Collection Only)

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tarah Ballinger, MD

Phone

317-944-0920

Facility Name

Johns Hopkins Hospital (Data Collection Only)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Sheng, MD

Phone

410-614-0682

Facility Name

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Phone

646-888-4714

Facility Name

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Phone

646-888-4714

Facility Name

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Phone

646-888-4714

Facility Name

Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only)

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesus Anampa Mesias, MD

Phone

866-633-8255

Facility Name

Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Phone

646-888-4714

Facility Name

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Phone

646-888-4714

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Phone

646-888-4714

First Name & Middle Initial & Last Name & Degree

Lee Jones, PhD

Phone

646-888-8103

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Facility Name

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Iyengar, MD

Phone

646-888-4714

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Hormone Receptor Positive Metastatic Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial