Scalp Cooling in MBC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle
Disqualifiers
Known hematological malignancies (i.e. leukemia or lymphoma)
Known scalp metastases.
Baseline alopecia (defined CTCAE 5.0 grade > 0, see Appendix B)
Subjects with cold agglutinin disease or cold urticaria.
Trial design
Design model
Parallel
Treatments tested in this trial
Paxman Scalp Cooling System
DeviceCap attached to coolant lines connected to a refrigeration unit placed on scalp
Eribulin
DrugIntravenous Infusion
Sacituzumab govitecan
DrugIntravenous Infusion
Trastuzumab deruxtecan
DrugIntravenous Infusion
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)Experimental treatment 2 interventions
Group B: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)Active comparator 1 intervention
Group C: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)Experimental treatment 2 interventions
Group D: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)Active comparator 1 intervention
Group E: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)Experimental treatment 2 interventions
Group F: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEMActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hair Loss Rate
Hair loss rate defined as CTCAE v5.0 alopecia grade 1 or higher compared in the scalp cooling group using the Paxman Hair Loss Prevention System (PSCS) and group not using scalp cooling.
Time frame
Up to 2 yearsSecondary outcomes
1
Change in Patient Reported Quality of Life
The Chemotherapy-Induced Alopecia Distress Scale (CADS) \[25\] will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).
Time frame
Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days2
Change in Patient Reported Quality of Life
Body image scale (BIS) will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).
Time frame
Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Paxman Coolers Limited
Collaborator
AstraZeneca
Collaborator
Eisai Inc.
Collaborator
Daiichi Sankyo
Collaborator
Gilead Sciences
Collaborator
Source ClinicalTrials.gov