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
Qualifiers
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
Treatments tested in this trial
- Paxman Scalp Cooling System
- Eribulin
- Sacituzumab govitecan
- Trastuzumab deruxtecan
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
2Brigham and Women's Hospital02115, BostonMassachusetts, United States
Dana Farber Cancer Institute02115, BostonMassachusetts, United States
Sponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Paxman Coolers Limited
Collaborator
AstraZeneca
Collaborator
Eisai Inc.
Collaborator
Daiichi Sankyo
Collaborator
Gilead Sciences
Collaborator
Source ClinicalTrials.gov