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Scalp Cooling in MBC

StatusRecruiting
PhasePhase 2
Started2021-10-07
View on ClinicalTrials.gov ↗

Amendment history

2026-06-16
Study Status v9
Primary completion date2026-06-01→2028-06-01
Completion date2028-06-01→2030-06-01
2025-11-18
2 amendments v7-v8
2 re-verifications since 2024-11-05, no change to tracked fields
2024-06-24
Study Status v6
Primary completion date2024-06-01→2026-06-01
Completion date2026-06-01→2028-06-01
2024-05-13
3 amendments v3-v5
3 re-verifications since 2023-05-22, no change to tracked fields
2023-02-06
Study Status, Sponsor/Collaborators v2
Primary completion date2023-06-01→2024-06-01
2022-01-18
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-11-30→confirmed 2021-10-07
Study sitesdetails revised at 2 of 2 sites
Collaborators2 to 5 entries
AZ/AstraZeneca Eisai Inc. Daiichi Sankyo Gilead Sciences
2021-07-22
Original filing
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 Details
NCT Number NCT04986579
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Gilead Sciences
Conditions Metastatic Breast Cancer, Chemotherapy-induced Alopecia
Enrollment 120 participants
Start Date 2021-10-07
Primary Completion 2028-06-01 (estimated)
Study Completion 2030-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-18