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Scalp Cooling in MBC
Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the 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
What is being tested
- Paxman Scalp Cooling System (device)
- Eribulin (drug)
- Sacituzumab govitecan (drug)
- Trastuzumab deruxtecan (drug)
Sponsor: Dana-Farber Cancer Institute · Participants: 120 · Started: Oct 7, 2021
Contact the study team
- Elahe Salehi, DNP, ANP-BC · Phone: 617-632-3800
Official record on ClinicalTrials.gov — NCT04986579
Locations in the U.S.
| Massachusetts | Brigham and Women's Hospital, Boston Dana Farber Cancer Institute, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.