Trial NCT04986579
Scalp Cooling in MBC
- Phase
- Phase 2
- Sponsor
- Dana-Farber Cancer Institute
- Conditions
- Metastatic Breast Cancer; Chemotherapy-induced Alopecia
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2Performance status
* 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.
Exclusion Criteria:
* Known hematological malignancies (i.e. leukemia or lymphoma)Prior malignancy
* Known scalp metastases.
* Baseline alopecia (defined CTCAE 5.0 grade > 0, see Appendix B)
* Subjects with cold agglutinin disease or cold urticaria.
* Subjects who are scheduled for bone marrow ablation chemotherapy.
* 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.
* Subjects who have lichen planus or lupus.
* Participants who are receiving any additional anti-cancer agents
Restrictions found (2)
- Performance statusOutrightinclusion
ECOG PS ≤ 2
Show in the text - Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Brigham and Women's Hospital · Boston, Suffolk County
- Dana Farber Cancer Institute · Boston, Suffolk County