Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

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

Sponsors

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Source Memorial Sloan Kettering Cancer Center
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.

Overall Status Recruiting
Start Date 2019-06-12
Completion Date 2023-08-01
Primary Completion Date 2023-08-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
maximum feasible dose (MFD) 24 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: Exercise Treatment

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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

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) - ECOG performance status of 0 to 1 or KPS of 80% - 100% - 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

Gender:

Female

Gender Based:

Yes

Gender Description:

Breast Cancer

Minimum Age:

19 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Neil Iyengar, MD Principal Investigator Memorial Sloan Kettering Cancer Center
Overall Contact

Last Name: Neil Iyengar, MD

Phone: 646-888-4714

Email: [email protected]

Location
Facility: Status: Contact:
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge, New Jersey, 07920, United States Recruiting Neil Iyengar, MD 646-888-4714
Memoral Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown, New Jersey, 07748, United States Recruiting Neil Iyengar, MD 646-888-4714
Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale, New Jersey, 07645, United States Recruiting Neil Iyengar, MD 646-888-4714
Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only) | Bronx, New York, 10467, United States Recruiting Jesus Anampa Mesias, MD 866-633-8255
Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity) | Commack, New York, 11725, United States Recruiting Neil Iyengar, MD 646-888-4714
Memoral Sloan Kettering Westchester (Limited Protocol Activities) | Harrison, New York, 10604, United States Recruiting Neil Iyengar, MD 646-888-4714
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Recruiting Neil Iyengar, MD 646-888-4714 Neil Iyengar, MD Principal Investigator
Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale, New York, 11553, United States Recruiting Neil Iyengar, MD 646-888-4714
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: aerobic training 90 mins/wk

Type: Experimental

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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

Label: aerobic training 150 mins/wk

Type: Experimental

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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

Label: aerobic training 225 mins/wk

Type: Experimental

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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

Label: aerobic training 300 mins/week

Type: Experimental

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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

Patient Data Yes
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Intervention 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, or 300 mins/week).

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News