Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)

Eligibility Criteria

• 1. Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III.
• 2. A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent.
• 3. Plan to complete the current CT regimen within six months.
• 4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin. Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the Amma PSCS will not be used during the post-CT targeted and/or hormonal therapy period.
• 5. At least two years out from the last CT causing hair loss with complete recovery of hair.
• 6. Age \>=21 years
• 7. Eastern Cooperative Oncology Group (ECOG) performance status of \<=1.
• 8. Ability to understand and the willingness to sign a written informed consent document.
• 1. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale.
• 2. Autoimmune disease affecting hair, e.g., alopecia areata, systemic lupus with associated hair loss, others.
• 3. A history of whole brain radiation.
• 4. Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.)
• 5. Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted.
• 6. Concurrent use of hair growth products, such as Nutrafol, minoxidil, and Keranique.
• 7. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up.
• 8. History of persistent alopecia (any grade) induced by prior chemotherapeutic regimens.
• 9. History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss.
• 10. Cold sensitivity.
• 11. Intercurrent life-threatening malignancy.
• 12. Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism.
• 13. History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia.
• 14. Concurrent hematologic malignancy.
• 15. Concurrent treatment with any investigational agent.
• 16. Any reason the investigator does not believe the patient is a good candidate for the study.
• 17. Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.