Scalp Cooling in MBC
Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
1 other identifier
interventional
120
1 country
2
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2021
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
October 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
November 19, 2025
November 1, 2025
4.7 years
July 20, 2021
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hair Loss Rate
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.
Up to 2 years
Secondary Outcomes (2)
Change in Patient Reported Quality of Life
Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days
Change in Patient Reported Quality of Life
Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days.
Study Arms (6)
ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
EXPERIMENTALParticipants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with Eribulin. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
ACTIVE COMPARATORParticipants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with Eribulin. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
EXPERIMENTALParticipants will use Paxman Scalp Cooling System (PSCS) on days 1 and 21 of each of their standard of care (SOC) treatment cycles with SACITUZUMAB GOVITECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
ACTIVE COMPARATORParticipants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with SACITUZUMAB GOVITECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
EXPERIMENTALParticipants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with TRASTUZUMAB DERUXTECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM
ACTIVE COMPARATORParticipants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with TRASTUZUMAB DERUXTECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Interventions
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
Intravenous Infusion
Intravenous Infusion
Intravenous Infusion
Eligibility Criteria
You 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Paxman Coolers Limitedcollaborator
- AstraZenecacollaborator
- Eisai Inc.collaborator
- Daiichi Sankyocollaborator
- Gilead Sciencescollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elahe Salehi, DNP, ANP-BC
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 20, 2021
First Posted
August 3, 2021
Study Start
October 7, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2028
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.