Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

Inclusion Criteria: * Female patients \>/= 18 years of age * Documented diagnosis of stage I or II breast cancer * A planned course of chemotherapy in the adjuvant or neoadjuvant setting with curative intent including one of the following regimens: * Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 2 - 3 weeks * Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 3 weeks * Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab * Paclitaxel 175 mg/m2 IV every 2 weeks x 4 - 6 cycles (without an anthracycline) * Paclitaxel weekly and carboplatin AUC 2 weekly or AUC 6 every 3 weeks IV x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks * Docetaxel 75 mg/m2 and carboplatin AUC 6 IV every 3 weeks x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks * Targeted agents such as trastuzumab or lapatinib are allowed * Plan to complete chemotherapy within 6 months * At least two years out from the last chemotherapy causing hair loss with complete recovery of hair * Karnofsky performance status \>/= 80% * Willing and able to sign informed consent for protocol treatment * Willing to participate in study procedures including having photographs of the head before the first cycle of chemotherapy and 1 month after the last chemotherapy * Willing to enroll in an extension protocol for follow up for 5 years following the end of chemotherapy treatment Exclusion Criteria: * Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale * Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss * A history of whole brain radiation * Plans to use a chemotherapy regimen other than those specified in the inclusion criteria. Specifically, patients receiving a regimen including both an anthracycline and a taxane are not eligible for this trial (AC/T, EC/T, TAC, etc.) * Concurrent hormone therapy with chemotherapy. Hormone therapy should be used as indicated following completion of chemotherapy * Underlying clinically significant liver disease including active viral hepatitis with abnormal liver function tests \>1.5 times the upper limit of normal, including alkaline phosphatase, AST, and total bilirubin. Patients with Gilbert´s disease (elevated indirect bilirubin only) will be eligible for participation. * Clinically significant renal dysfunction defined as serum creatinine \> upper limit of normal. * A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up * A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens * Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause hair loss * Intercurrent life-threatening malignancy * A history of cold agglutinin disease or cryoglobulinemia. * Evidence of untreated or poorly controlled hyper or hypothyroidism * A history of silicon allergy * American Society of Anesthesiologist Class ≥3