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

Inclusion criteria

• Female patients ≥ 21 years of age
• Documented diagnosis of breast cancer, stage I, II, or III
• A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
• 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
• Plan to complete the current CT regimen within six months
• At least two years out from the last CT causing hair loss with complete recovery of hair
• Karnofsky17 performance status 80% or greater
• Willing and able to sign informed consent for this study
• Willing and able to complete all required study procedures

Exclusion criteria

• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
• Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others
• A history of whole brain radiation
• 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.)
• Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
• Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique
• A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
• History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
• History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss
• Cold sensitivity
• Intercurrent life-threatening malignancy
• Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism
• History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
• Concurrent hematologic malignancy
• Participation in any other clinical investigation
• Concurrent treatment with any investigational agent
• Any reason the investigator does not believe the patient is a good candidate for the study