NCT04986579RecruitingPhase 2
Scalp Cooling in MBC
Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 20 Jul 2021
- Start date
- 7 Oct 2021
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04986579
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 7 Oct 2021 to the primary completion date, 1 Jun 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are scheduled for bone marrow ablation chemotherapy.
- Participants who are receiving any additional anti-cancer agents
Other illness
- Known hematological malignancies (i.e. leukemia or lymphoma)
- Subjects with cold agglutinin disease or cold urticaria.
- 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.
Other
- Known scalp metastases.
- Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B)
- Subjects who have lichen planus or lupus.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.