Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

Eligibility Criteria

• 1. Female patients ≥ 21 years of age
• 2. Documented diagnosis of breast cancer, stage I, II, or III
• 3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
• 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. Plan to complete the current CT regimen within six months
• 6. At least two years out from the last CT causing hair loss with complete recovery of hair
• 7. Karnofsky17 performance status 80% or greater
• 8. Willing and able to sign informed consent for this study
• 9. Willing and able to complete all required study procedures
• 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 (AC/T, EC/T, TAC, etc.)
• 5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
• 6. Current and/or prior 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 grade 2 (or higher) alopecia 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. Participation in any other clinical investigation
• 16. Concurrent treatment with any investigational agent
• 17. Any reason the investigator does not believe the patient is a good candidate for the study