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Scalp Cooling for the Prevention of Hair Loss in Patients with Metastatic Breast Cancer Receiving Chemotherapy
Trial Status: active
This phase II trial tests whether scalp cooling using the Paxman Hair Loss Prevention System (PSCS) works to prevent hair loss in patients with breast cancer that has spread to other parts of the body (metastatic) and are receiving treatment with one of the following drugs: sacituzumab govitecan, trastuzumab deruxtecan, eribulin, or datopotamab deruxtecan. PSCS is a device with a cooling cap attached to coolant lines connected to a refrigeration unit. Scalp cooling may prevent hair loss in two ways. First, cooling of the scalp causes blood vessels to close which reduces the amount of chemotherapy taken up into hair follicles. Cold temperatures also reduce metabolic activity, which lessens the effects of chemotherapy on hair follicles. PSCS may be a possible treatment for hair loss prevention in patients with metastatic breast cancer.
Inclusion Criteria
Men and women with a diagnosis of metastatic invasive breast cancer with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
Participant is >= 18 years old
Full set of 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
* Datopotamab deruxtecan (Dato-DXd) 6mg/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 Common Terminology Criteria for Adverse Events [CTCAE] 5.0 grade > 0)
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
Previously enrolled subjects are ineligible for re-registration under a different arm if they previously came off trial for grade 2 alopecia
Additional locations may be listed on ClinicalTrials.gov for NCT04986579.
I. To compare hair loss rate in the scalp cooling group after use of the Paxman Hair Loss Prevention System (PSCS) and no scalp cooling group (control) after receiving standard of care treatment with sacituzumab govitecan (IMMU-132), trastuzumab deruxtecan, or eribulin, or treatment with datopotamab deruxtecan (Dato-DXd) until 2-4 weeks after completion of therapy, or at disease progression, or at 6 months on trial, or at time of grade 2 alopecia, whichever occurs first.
SECONDARY OBJECTIVE:
I. To assess the impact of scalp cooling on quality of life (QOL) in these participants.
EXPLORATORY OBJECTIVES:
I. Overall survival.
II. Incidence rate of isolated scalp metastasis.
III. Artificial intelligence (AI)-based alopecia assessment for arms G & H only.
OUTLINE: Based on their planned chemotherapy regimen, patients elect their own assignment to 1 of 8 arms.
ARM A: Patients receive at least 4 cycles of planned chemotherapy with eribulin intravenously (IV) on days 1 and 8 of each 21-day cycle. Patients undergo a cap fitting at baseline and receive scalp cooling via PSCS during every standard of care chemotherapy treatment session in the absence of unacceptable toxicity.
ARM B: Patients receive at least 4 cycles of planned chemotherapy with eribulin IV on days 1 and 8 of each 21-day cycle.
ARM C: Patients receive at least 4 cycles of planned chemotherapy with sacituzumab govitecan IV on days 1 and 8 of each 21-day cycle. Patients undergo a cap fitting at baseline and receive scalp cooling via PSCS during every standard of care chemotherapy treatment session in the absence of unacceptable toxicity.
ARM D: Patients receive at least 4 cycles of planned chemotherapy with sacituzumab govitecan IV on days 1 and 8 of each 21-day cycle.
ARM E: Patients receive at least 4 cycles of planned chemotherapy with trastuzumab deruxtecan IV on day 1 of each 21-day cycle. Patients undergo a cap fitting at baseline and receive scalp cooling via PSCS during every standard of care chemotherapy treatment session in the absence of unacceptable toxicity.
ARM F: Patients receive at least 4 cycles of planned chemotherapy with trastuzumab deruxtecan IV on day 1 of each 21-day cycle.
ARM G: Patients receive at least 4 cycles of planned chemotherapy with datopotamab deruxtecan IV on day 1 of each 21-day cycle. Patients undergo a cap fitting at baseline and receive scalp cooling via PSCS during every standard of care chemotherapy treatment session in the absence of unacceptable toxicity.
ARM H: Patients receive at least 4 cycles of planned chemotherapy with datopotamab deruxtecan IV on day 1 of each 21-day cycle.
After completion of study treatment, patients are followed for 2-4 weeks after completion of chemotherapy treatment, or at disease progression, or at 6 months on trial, or at the time of grade 2 alopecia, whichever occurs first.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
