NCT04986579 · Dana-Farber Cancer Institute
Scalp Cooling in MBC
What this study is about
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 the usual treatment treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.
View original scientific description
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.
Interventions
DEVICE
Paxman Scalp Cooling System
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
DRUG
Eribulin
Intravenous Infusion
DRUG
Sacituzumab govitecan
Intravenous Infusion
DRUG
Trastuzumab deruxtecan
Intravenous Infusion
Primary outcome measures
Hair Loss Rate
Time frame: Up to 2 years
Hair loss rate defined as CTCAE v5.0 alopecia grade 1 or higher compared in the scalp cooling group using the Paxman Hair Loss Prevention System (PSCS) and group not using scalp cooling.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Collaborators
Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Gilead Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations