Recruiting
Phase 2

Scalp Cooling

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04986579

Conditions

Metastatic Breast Cancer

Chemotherapy-induced Alopecia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paxman Scalp Cooling System

Eribulin

Sacituzumab govitecan

Trastuzumab deruxtecan

Study Details

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

Conditions

Metastatic Breast Cancer

Chemotherapy-induced Alopecia

Study ID

NCT04986579

Start date

Oct 7, 2021

Status verified date

Jun, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants 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.

active comparator: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants 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.

experimental: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants 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.

active comparator: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants 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.

experimental: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants 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.

active comparator: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM

Participants 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

Paxman Scalp Cooling System

Cap attached to coolant lines connected to a refrigeration unit placed on scalp

Eribulin

Intravenous Infusion

Sacituzumab govitecan

Intravenous Infusion

Trastuzumab deruxtecan

Intravenous Infusion

Primary outcome measure

  • Hair Loss Rate [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Elahe Salehi, DNP, ANP-BC

617-632-3800elahe_salehi@dfci.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elahe Salehi, DNP, ANP-BC

617-632-3800elahe_salehi@dfci.harvard.edu

Principal Investigator:

Elahe Salehi, DNP, ANP-BC

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elahe Salehi, DNP, ANP-BC

617-632-3800elahe_salehi@dfci.harvard.edu

Principal Investigator:

Elahe Salehi, DNP, ANP-BC

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Metastatic Breast Cancer
  • Chemotherapy-induced Alopecia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-06-18.