Keratinocyte Growth Factor-Hair Serum for the Prevention of Chemotherapy Induced Alopecia in Stage I-III Breast Cancer

PRIMARY OBJECTIVE:

I. To provide a preliminary assessment of the efficacy of keratinocyte growth factor (KGF)-hair serum (HS) as a prophylactic treatment for chemotherapy induced alopecia.

SECONDARY OBJECTIVES:

I. To estimate hair preservation as assessed by participant and physician.

II. To estimate participant reported comfort.

III. To evaluate quality of life.

IV. To evaluate the incidence of adverse events for topical application.

V. To evaluate if topical hair serum results in faster hair growth after completion of chemotherapy in those who had grade 2 or higher alopecia while on chemotherapy.

VI. To evaluate responses to chemotherapy at time of surgery (for patients undergoing neoadjuvant chemotherapy).

OUTLINE:

PART I: Beginning 48 hours before the first dose of chemotherapy, patients apply KGF-HS topically to the scalp twice daily (BID) for up to 4 cycles of chemotherapy. Patients may continue KGF-HS use during additional chemotherapy per standard of care and for up to 6 months post-chemotherapy.

PART II: Patients are randomized to 1 of 2 arms.

ARM I: Beginning 48 hours before the first dose of chemotherapy, patients apply KGF-HS topically to the scalp BID for up to 4 cycles of chemotherapy. Patients may continue KGF-HS use the duration of rest of chemotherapy per standard of care and for up to 6 months post-chemotherapy.

ARM II: Beginning 48 hours before the first dose of chemotherapy, patients apply placebo topically to the scalp BID for up to 4 cycles of chemotherapy. Patients may apply KGF-HS for the duration of rest of chemotherapy per standard of care and for up to 6 months post-chemotherapy.

After completion of study treatment, patients are followed up at 1, 3 and 6 months.