Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
Dana-Farber Cancer Institute
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
Description
This study is a prospective, controlled, pivotal clinical investigation to assess the efficacy of the Paxman Scalp Cooling System (PSCS) at preventing hair loss in people undergoing treatment for metastatic breast cancer with either Sacituzumab govitecan (IMMU-132 or Trodelvy™), trastuzumab deruxtecan (DS-8201a or Enhertu®), or Eribulin (Halaven®). The U.S. Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System as a treatment option for preventing hair loss while patients are undergoing chemotherapy. This system has however not been specifically studied to look at its…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DevicePaxman Scalp Cooling System
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
- DrugEribulin
Intravenous Infusion
- DrugSacituzumab govitecan
Intravenous Infusion
- DrugTrastuzumab deruxtecan
Intravenous Infusion
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts