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

Inclusion 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 withcurative intent

4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such ascyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intendedfor use after completion of the taxane-containing CT regimen will not be consideredpart of the study treatment period, and the AMMA PSCS will not be used during thepost-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 ofhair

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

Exclusion Criteria:

1. Patients with female pattern baldness resembling picture I-3 or higher on the Savinscale

2. Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus withassociated 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 includingan 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, andKeranique

7. A serious concurrent infection or medical illness which would jeopardize the abilityof the patient to complete the planned therapy and follow-up

8. History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeuticregimens

9. History of and/or current exposure to other agents, drugs, device, or procedure thatmay 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 thestudy