Recruiting
Scalp Cooling in MBC
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
ClinicalTrials.gov IDNCT04986579
PhasePHASE2
Enrollment120
SponsorDana-Farber Cancer Institute
Age18 Years
SexALL
Conditions studied
Metastatic Breast Cancer, Chemotherapy-induced Alopecia
About this study
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
Interventions
- Device: Paxman Scalp Cooling System — Cap attached to coolant lines connected to a refrigeration unit placed on scalp
- Drug: Eribulin — Intravenous Infusion
- Drug: Sacituzumab govitecan — Intravenous Infusion
- Drug: Trastuzumab deruxtecan — Intravenous Infusion
Primary outcomes
- Hair Loss Rate (Up to 2 years)
Eligibility information
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 the first dose of therapy in participants that elect to participate in the scalp cooling group.
Exclusion Criteria:
* 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.
* Subjects who are scheduled for bone marrow ablation chemotherapy.
* Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator.
* Subjects who have lichen planus or lupus.
* Participants who are receiving any additional anti-cancer agents
Study locations
- Brigham and Women's Hospital, Boston, Massachusetts 02115 United States
- Dana Farber Cancer Institute, Boston, Massachusetts 02115 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.