The Lily Device Trial

Inclusion criteria

• Adults ≥ age 18 with breast cancer stage 1, 2 or 3, who have been deemed appropriate for (neo-)adjuvant chemotherapy and have not yet begun any systemic therapy.
• Planned intravenous chemotherapy in the adjuvant or neoadjuvant setting with at least 4 cycles of chemotherapy, with one of the following regimens:

• Doxorubicin 60 mg/m^2 with cyclophosphamide 600 mg/m^2 every 2-3 weeks
• Doxorubicin 60 mg/m^2 with fluorouracil 500 mg/m^2 and cyclophosphamide 500 mg/m^2 every 2-3 weeks
• Paclitaxel 80-90 mg/m^2 weekly (every 3 weeks constitutes a cycle)
• Paclitaxel 175 mg/m^2 every 2-3 weeks
• Paclitaxel 80-90 mg/m^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 1.5 every week
• Paclitaxel 80-90 mg/m^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 5-6 every 3 weeks
• Docetaxel 75-100 mg/m^2 every 3 weeks
• Docetaxel 75 mg/m^2 with cyclophosphamide 600 mg/m^2 every 3 weeks
• Docetaxel 75 mg/m^2 with carboplatin AUC 5-6 every 3 weeks

• Concurrent administration with targeted agents/immunotherapy at standard doses (such as trastuzumab, pertuzumab, pembrolizumab) is allowed. Duration of targeted agents/immunotherapy is at the investigator's discretion.
• Participants on AC-T regimens who are prescribed with at least 4 treatments with anthracycline followed by at least 4 treatments with taxane are eligible for the study. In terms of data analysis, these participants are counted towards the anthracycline group
• Head size within the specified study sizing range.
• Plan to complete chemotherapy in ≤ 12 months.
• Willing and able to sign informed consent.
• Willing to comply and tolerate all study procedures including:

• Wearing the Lily device for the prescribed duration (device to be fitted before chemotherapy infusion, and worn during infusion and for at least two (2) hours and up to four (4) hours post infusion),
• Complete all study related questionnaires.
• Having photographs taken of the head at each visit.

To note:

• Participants who experience a hypersensitivity reaction to chemotherapy are allowed to continue in the study if the standard doses are maintained.
• Participants on the chemotherapy plan KEYNOTE-522 are eligible for this study.
• If a participant is prescribed a different chemotherapy treatment plan, they may be eligible for the study only if prior Sponsor approval is obtained.

Exclusion criteria

• Baseline alopecia defined as CTCAE v5.0 grade > 0.
• History of autoimmune disease associated with hair loss, e.g., alopecia areata, systemic lupus.
• History of whole brain irradiation.
• Recent chemotherapy (≤ 2 years), which caused hair loss.
• Participants who are receiving or are planning to receive hormone replacement therapy or anti-estrogen therapy during the study, whereby the therapy in question has a known profile for causing hair loss.
• Prescribed chemotherapy regimen with concurrent administration of taxane-based and anthracycline-based chemotherapy (i.e., infusion of both taxane and anthracycline agents on the same day).
• Positive pregnancy test at baseline for participants with childbearing potential, as per standard of care for chemotherapy patient.
• Known or suspected allergy or hypersensitivity to any component of the Lily device that comes into contact with the study participant.
• Participants with a history of Temporomandibular Joint Disorder.
• Any open wounds or sores on the participant's scalp or on part of the face where the device will be applied, which in the opinion of the investigator will not be healed prior to chemotherapy commencing.
• Serious infection or medical illness which would jeopardize the ability of the participant to complete the planned chemotherapy.
• Intercurrent life-threatening malignancy.
• An existing history of scalp metastases or suspicion of presence of scalp metastasis.
• Use of a cold cap, scalp cooling device or any other hair loss reduction device during the study.
• Participants who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study.
• Participants who do not have the mental or physical ability to comply with time schedules and further study procedures.
• Current participation in a clinical study or within the last 30 days prior to screening that may cause hair loss.
• Participation in this study at an earlier stage.