Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
Trial Parameters
Brief Summary
The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.
Eligibility Criteria
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 neoadjuvant setting 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 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. 5. At least two years out from the last CT causing hair loss with complete recovery of hair. 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 consent document. Exclusion Criteria: 1. Patients with