Scalp Cooling to Prevent Chemo-induced Hair Loss

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 ortaxane 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/m2with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as asingle agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 withpertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standarddoses
• 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 clinicallyindicated.
• Subjects must have TSH collected within 1 year prior to treatment and found withinnormal range.
• If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 monthsprior 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 withinacceptable limits.

Exclusion Criteria:

• Stage 3 or 4 breast cancer or any other concurrent malignancy including hematologicalmalignancies (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