What this study is
This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.
The name of the study intervention involved in this study is:
- Paxman Scalp Cooling System
What's being tested
- Paxman Scalp Cooling System
Intervention · DEVICE
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
- Eribulin
Intervention · DRUG
- Sacituzumab govitecan
Intervention · DRUG
- Trastuzumab deruxtecan
Intervention · DRUG
All of Eribulin, Sacituzumab govitecan, Trastuzumab deruxtecan
Intravenous Infusion
Study details
- Official title
- Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Conditions
- Metastatic Breast Cancer · Chemotherapy-induced Alopecia
- Enrolling
- 120 people
- Starts
- 2021-10-07
- Est. completion
- 2028-06-01
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Known hematological malignancies (i.e. leukemia or lymphoma)
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Elahe Salehi, DNP, ANP-BC · Contact617-632-3800elahe_salehi@dfci.harvard.edu
- Elahe Salehi, DNP, ANP-BC · Principal investigator
Brigham and Women's Hospital
Boston, Massachusetts, United States
RecruitingDana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Study team
Sponsor
Dana-Farber Cancer Institute
Study ID 21-169
Principal investigator
Elahe Salehi, DNP, ANP-BC
Dana-Farber Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.