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

ENROLLING
Protocol # :
21-169
Conditions
Metastatic Breast Cancer
Chemotherapy-induced Alopecia
Phase
II
Disease Sites
Breast
Principal Investigator
Salehi, Elahe
Site Research Nurses
Bowers, Jordan
Brule, Maurice, N.
Campbell, Margaret
Caradonna, Lisa
Cung, Connie
Dishman, Rachel, C.
Fleming, Norah, Michelle
Freeman, Stefani, Danielle
Gentile, Alissa
Hixon, Nicole, R.
Houghton, Nicole
Jeon, Maryangel, H.
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

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

21-169