The Lily Device Trial

Inclusion Criteria24

• 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.