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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240415

Enrollment

Registered

2024-10-18

Start date

2024-12-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Change in Hair Density (hairs/cm2) from baseline	—

Secondary

Measure	Time frame
-Dean Score -Cumulative incidence of Alopecia -QoL -Adverse events	—

Contacts

Public ContactMitsue Saito

Juntendo University School of Medicine Juntendo Hospital

mitsue@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026