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Assessing the Impact of Scalp Cooling in Patients with Metastatic Breast Cancer


Trial ID:NCT04986579

View complete trial on

Protocol #:21-169

877-DF-TRIAL (877-338-7425)

Condition(s):Chemotherapy-induced Alopecia, Metastatic Breast Cancer


Principal Investigator:Salehi, Elahe

Site Research Nurse(s):Bowers, Jordan,
Brule, Maurice, N.
Campbell, Margaret,
Caradonna, Lisa,
Dishman, Rachel, C.
Fleming, Norah, Michelle
Freeman, Stefani, Danielle
Gentile, Alissa,
Hixon, Nicole, R.
Jeon, Maryangel,
Kasparian, Elizabeth,
Kosinski, Michelle,
Macauley, Colleen,
Orechia, Meghan,
Patel, Nikita,
Piper, Audrey, L.
Roche, Kathleen, A.
Rutter, Morgan,

Trial Description:
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 Requirements:
- 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

Protocol #: 21-169

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