Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients

Inclusion criteria

• Age 18 years or older
• New diagnosis of breast cancer stage I-IV
• Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
• Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen:

• Concurrent trastuzumab at standard doses is allowed
• Concurrent pertuzumab at standard doses is allowed
• Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated
• For women of childbearing potential, a negative pregnancy test is needed within 7 days prior to study intervention, or whenever collected as per standard of care. For women who undergo fertility preservation or ovarian stimulation, a negative pregnancy test is not needed and eligibility due to positive pregnancy test will be determined by investigator discretion.

Exclusion criteria

• Any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
• Baseline alopecia (defined CTCAE v5.0 grade > 1)
• Subjects who are scheduled for bone marrow ablation chemotherapy
• Male gender
• Age >/= 75 years
• 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, subject may go on study at the discretion of the Principal Investigator.
• Subjects who have had prior chemotherapy
• Subjects who have had >/=1 previous chemotherapy exposure resulting in alopecia
• An existing history of scalp metastases or suspected presence of scalp metastasis
• Subjects with cold sensitivity, cryoglobulinemia, cryofibrinogenemia, or cold migraine pot-traumatic cold dystrophy
• Previously received, or scheduled to undergo skull irradiation