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