Scalp Cooling to Prevent Chemo-induced Hair Loss

Cooling the scalp during chemotherapy may help reduce the chances of losing hair during
treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may
stop patients who are undergoing chemotherapy from losing their hair.

Inclusion Criteria:

- New diagnosis of breast cancer stage 1-2

- Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent

- Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or
taxane based chemotherapy regimen,

- Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide
600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2
with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2
weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a
single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with
pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide
600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard
doses

- Concurrent traztuzumab at standard doses is allowed

- Concurrent pertuzumab at standard doses is allowed

- Administration of chemotherapy on a dose dense schedule is allowed as clinically
indicated.

- Subjects must have TSH collected within 1 year prior to treatment and found within
normal range.

- If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months
prior to treatment and found to be within normal limits.

- CBC and CMP should be done within 4 weeks prior to treatment and found to be within
acceptable limits.

Exclusion Criteria:

- Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological
malignancies (i.e. leukemia or lymphoma)

- Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale)

- Subjects with cold agglutinin disease or cold urticaria

- Subjects who are scheduled for bone marrow ablation chemotherapy

- Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)

- Male gender

- Age >= 70 years