Scalp Cooling in MBC

Korábbi kezelés

• Subjects who are scheduled for bone marrow ablation chemotherapy.
• Participants who are receiving any additional anti-cancer agents

Más betegség

• Known hematological malignancies (i.e. leukemia or lymphoma)
• Subjects with cold agglutinin disease or cold urticaria.
• Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator.

Egyéb

• Known scalp metastases.
• Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B)
• Subjects who have lichen planus or lupus.

• Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2
• Participant is ≥ 18 years old.
• Hair present at baseline.
• One of the following full dose chemotherapy regimens must be planned for at least 4 cycles:
  • Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle
  • Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks
  • Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle
• The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group.