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

Inclusion 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 neoadjuvantsetting 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 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. At least two years out from the last CT causing hair loss with complete recovery ofhair.

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 consentdocument.

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 (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 duringchemotherapy 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 abilityof the patient to complete the planned therapy and follow-up.

8. History of persistent alopecia (any grade) 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. Concurrent treatment with any investigational agent.

16. Any reason the investigator does not believe the patient is a good candidate for thestudy.

17. Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitantadministration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.