No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
120 (estimated)
Sponsor
Dana-Farber Cancer Institute · Other
Who this trial is looking for
This trial is looking for men and women with metastatic breast cancer who are undergoing chemotherapy. Participants will compare hair loss between those who use a cooling device on their scalp and those who do not.
Are You a Good Fit for This Trial?
You may be able to join if
I have metastatic invasive breast cancer.
I am at least 18 years old.
I have hair present at the start of the trial.
I will receive certain chemotherapy treatments for at least 4 cycles.
You may not be able to join if
I have a history of leukemia or lymphoma.
I have scalp metastases.
I have baseline hair loss.
I have cold agglutinin disease or cold urticaria.
I am scheduled for bone marrow ablation chemotherapy.
I have a history of migraines or headaches as diagnosed by a doctor.
I have lichen planus or lupus.
I am receiving other anti-cancer agents.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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)…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
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