Metastatic Breast CancerPhase 2NCT04986579
Scalp Cooling in MBC
A Phase 2 study testing Paxman Scalp Cooling System, Eribulin and Sacituzumab govitecan in people with Metastatic Breast Cancer and Chemotherapy-induced Alopecia, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Chemotherapy-induced Alopecia
- What is being tested?
- Paxman Scalp Cooling System, Eribulin and Sacituzumab govitecan
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2021to 1 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Elahe Salehi, DNP, ANP-BC, 617-632-3800, elahe_salehi@dfci.harvard.edu
Elahe Salehi, DNP, ANP-BC
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Elahe Salehi, DNP, ANP-BC, 617-632-3800, elahe_salehi@dfci.harvard.edu
Elahe Salehi, DNP, ANP-BC
About this study
Official title: Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
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
Read the detailed description
This study is a prospective, controlled, pivotal clinical investigation to assess the efficacy of the Paxman Scalp Cooling System (PSCS) at preventing hair loss in people undergoing treatment for metastatic breast cancer with either Sacituzumab govitecan (IMMU-132 or Trodelvy™), trastuzumab deruxtecan (DS-8201a or Enhertu®), or Eribulin (Halaven®).
The U.S. Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System as a treatment option for preventing hair loss while patients are undergoing chemotherapy. This system has however not been specifically studied to look at its ability to prevent hair loss in patients specifically receiving sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.
The research study procedures include: screening for eligibility, photographs, hair loss assessments, questionnaires and study treatment including evaluations and follow up visits.
Participants will receive study treatment with scalp cooling with standard of care chemotherapy treatment and will be followed for 2-4 weeks after completion of treatment with chemotherapy.
It is expected that about 120 people will take part in this research study.
Paxman Coolers Limited is a medical device company and is supporting this research study by providing access to the investigational device, Paxman Scalp Cooling System.
- Being tested
- Paxman Scalp Cooling System, Eribulin, Sacituzumab govitecan, Trastuzumab deruxtecan
- Keywords
- Metastatic Breast Cancer, Chemotherapy-induced Alopecia
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxman Scalp Cooling SystemDevice
Also called Scalp Cooling Cap
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
EribulinDrug
Also called Halaven
Intravenous Infusion
Sacituzumab govitecanDrug
Also called Trodelvy, IMMU-132
Intravenous Infusion
Trastuzumab deruxtecanDrug
Also called Enhertu, DS-8201a
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) | Experimental | 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. Receives: Device: Paxman Scalp Cooling System; Drug: Eribulin |
| ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) | Active comparator | 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. Receives: Drug: Eribulin |
| SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) | Experimental | 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. Receives: Device: Paxman Scalp Cooling System; Drug: Sacituzumab govitecan |
| SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) | Active comparator | 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. Receives: Drug: Sacituzumab govitecan |
| TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) | Experimental | 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. Receives: Device: Paxman Scalp Cooling System; Drug: Trastuzumab deruxtecan |
| TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM | Active comparator | 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. Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (2)
Change in Patient Reported Quality of Life
The Chemotherapy-Induced Alopecia Distress Scale (CADS) [25] will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).
Measured: 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
Body image scale (BIS) will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start7 Oct 2021
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Gilead Sciences
- Responsible party
- Principal investigator, Elahe Salehi, NP, Dana-Farber Cancer Institute
- Investigators
- Elahe Salehi, DNP, ANP-BC, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986579
- Sponsor's protocol ID
- 21-169
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2021
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04986579
- Acronym / sponsor ID
- 21-169
- Keywords
- Metastatic Breast Cancer, Chemotherapy-induced Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Gilead Sciences
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a prospective, controlled, pivotal clinical investigation to assess the efficacy of the Paxman Scalp Cooling System (PSCS) at preventing hair loss in people undergoing treatment for metastatic breast cancer with either Sacituzumab govitecan (IMMU-132 or Trodelvy™), trastuzumab deruxtecan (DS-8201a or Enhertu®), or Eribulin (Halaven®).
The U.S. Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System as a treatment option for preventing hair loss while patients are undergoing chemotherapy. This system has however not been specifically studied to look at its ability to prevent hair loss in patients specifically receiving sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.
The research study procedures include: screening for eligibility, photographs, hair loss assessments, questionnaires and study treatment including evaluations and follow up visits.
Participants will receive study treatment with scalp cooling with standard of care chemotherapy treatment and will be followed for 2-4 weeks after completion of treatment with chemotherapy.
It is expected that about 120 people will take part in this research study.
Paxman Coolers Limited is a medical device company and is supporting this research study by providing access to the investigational device, Paxman Scalp Cooling System.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) | Experimental | Device: Paxman Scalp Cooling System, Drug: EribulinParticipants 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 comparator | Drug: EribulinParticipants 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) | Experimental | Device: Paxman Scalp Cooling System, Drug: Sacituzumab govitecanParticipants 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 comparator | Drug: Sacituzumab govitecanParticipants 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) | Experimental | Device: Paxman Scalp Cooling System, Drug: Trastuzumab deruxtecanParticipants 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 comparator | Drug: Trastuzumab deruxtecanParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paxman Scalp Cooling SystemAlso: Scalp Cooling CapCap attached to coolant lines connected to a refrigeration unit placed on scalp | Device | ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS), SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS), TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) |
| EribulinAlso: HalavenIntravenous Infusion | Drug | ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS), ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) |
| Sacituzumab govitecanAlso: Trodelvy, IMMU-132Intravenous Infusion | Drug | SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS), SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) |
| Trastuzumab deruxtecanAlso: Enhertu, DS-8201aIntravenous Infusion | Drug | TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS), TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM |
Primary outcome
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.
2 secondary outcomes
Change in Patient Reported Quality of Life
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elahe Salehi, DNP, ANP-BC principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paxman Scalp Cooling System, Eribulin and Sacituzumab govitecan in people with Metastatic Breast Cancer and Chemotherapy-induced Alopecia, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elahe Salehi, DNP, ANP-BC (617-632-3800, elahe_salehi@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Loss Rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.