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