A Multicenter Clinical Study Assessing Scalp Hair Density Changes in patients with previously treated HER2-positive or Hormone Receptor-Positive/HER2-low unresectable or recurrent breast cancer who received trastuzumab deruxtecan (SHAROT study)

未提供0 个研究点目标入组 40 人开始时间: 2024年12月2日最近更新: 2025年5月15日

试验速览

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•Patients are at least 18 years of age.
•Written and signed informed consent obtained prior to participation in this study.
•Pathologically documented unresectable or recurrent HER2-positive or hormone receptor-positive/HER2-low breast cancer with a history of chemotherapy.
•Patients are scheduled to receive T-DXd treatment.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

•Patients have a history of T-DXd treatment.
•Patients have a complication or history of interstitial lung disease.
•Patients are pregnant, lactating, may be currently pregnant, or do not intend to use contraception.
•Patients are diagnosed with brain metastases and have received or are planning to receive radiation therapy from discontinuation of prior anti-cancer drug treatment to the start of T-DXd treatment
•Patients are judged by the principal investigator or investigator to have Grade 2 alopecia related to anti-cancer drug treatment to CTCAE Version
•at the time of consent.
•Patients have the following complications:
•Alopecia due to causes other than anti-cancer drug treatment.
•Atopic dermatitis.
•Autoimmune diseases with skin symptoms (such as systemic lupus erythematosus, systemic scleroderma, dermatomyositis, Sjogren's syndrome, psoriasis, etc.).
•Patients desire to undergo scalp cooling therapy in conjunction with T-DXd treatment.
•Patients are judged by the principal investigators or investigators to be ineligible for this study for any other reason.

Change in Hair Density (hairs/cm2) from baseline

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发起方

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