Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Who is this study for? Patients with Metastatic Breast Cancer, Chemotherapy-induced Alopecia
What treatments are being studied? Trastuzumab Deruxtecan
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The name of the study intervention involved in this study is: * Paxman Scalp Cooling System

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2

• Participant is ≥ 18 years old.

• Hair present at baseline.

• One of the following full dose chemotherapy regimens must be planned for at least 4 cycles:

‣ Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle

⁃ Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks

⁃ Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle

• The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Elahe Salehi, DNP, ANP-BC
elahe_salehi@dfci.harvard.edu
617-632-3800
Time Frame
Start Date: 2021-10-07
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 120
Treatments
Experimental: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with Eribulin.~Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Active_comparator: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with Eribulin.~Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Experimental: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
Participants will use Paxman Scalp Cooling System (PSCS) on days 1 and 21 of each of their standard of care (SOC) treatment cycles with SACITUZUMAB GOVITECAN.~Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Active_comparator: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with SACITUZUMAB GOVITECAN.~Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Experimental: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with TRASTUZUMAB DERUXTECAN.~Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Active_comparator: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM
Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with TRASTUZUMAB DERUXTECAN.~Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Sponsors
Collaborators: Eisai Inc., Daiichi Sankyo, AstraZeneca, Gilead Sciences, Paxman Coolers Limited
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov