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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)

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)

Saito Mitsue

Juntendo University School of Medicine Juntendo Hospital

3-1-3 Hongo, Bunkyo-ku, Tokyo

mitsue@juntendo.ac.jp

Saito Mitsue

Juntendo University School of Medicine Juntendo Hospital

3-1-3 Hongo, Bunkyo-ku, Tokyo

+81-3-3813-3111

mitsue@juntendo.ac.jp

Not Recruiting

Oct. 18, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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

1) Patients have a history of T-DXd treatment.
2) Patients have a complication or history of interstitial lung disease.
3) Patients are pregnant, lactating, may be currently pregnant, or do not intend to use contraception.
4) 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
5) Patients are judged by the principal investigator or investigator to have Grade 2 alopecia related to anti-cancer drug treatment to CTCAE Version 5. at the time of consent.
6) 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.).
7) Patients desire to undergo scalp cooling therapy in conjunction with T-DXd treatment.
8) Patients are judged by the principal investigators or investigators to be ineligible for this study for any other reason.

Both

HER2-positive or Hormone Receptor-Positive/HER2-low unresectable or recurrent breast cancer

The photographs of the participants' head are taken by a digital camera from five angles and a handheld digital microscope at the five designed sites to evaluate hair density change, blood sample are collected to evaluate the factor related to hair growth and FACT-B questionnaire and any change in hair are compiled by participants themselves using ePRO to evaluate QoL, in addition to usual routine care.

Change in Hair Density (hairs/cm2) from baseline

-Dean Score
-Cumulative incidence of Alopecia
-QoL
-Adverse events

+81-3-5802-1584

Sept. 09, 2024

none