Randomized Study Comparing Electronic Patient Reported Outcomes(ePROs) Monitoring with Routine Follow Up During Trastuzumab Deruxtecan Treatment

JRCT ID: jRCTs031200387

Registered date:01/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 25/03/2021
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Divide the group into two groups: those that do home monitoring with ePRO and those that do not

Outcome(s)

• Primary Outcome: Change in global health status/QoL from baseline to 24 weeks as measured by EORTC-QLQ-C30

Secondary Outcome

1.HRQoL
Change in each domain (excluding the primary endpoint) measured by EORTC-QLQ-C30 from baseline to 24 weeks, and from baseline to all observation periods
2. Time to Deterioration
EORTC QLQ-C30 (Global QoL) until it drops 10 points
3.Cancer related fatigue
4. Progression Free Survival
5. Time to Treatment Failure
6. Overall Survival
7. Outpatient treatment
8.Self-reported adherence in the ePRO monitoring group
9. Adverse Event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1.A patient who has the ability to sign and date the consent form with an understanding of its contents and the information provided in the consent form.
2. A women who is at least 20 years old at the time of registration.
3.A patient with confirmed HER2-positive breast cancer
4.A patient with inoperable or recurrent breast cancer with a history of chemotherapy
5.A patient who is scheduled to receive T-DXd and will be followed at their own hospital for at least 24 weeks from the date of enrollment
6.A patient with an ECOG PS of 2 or less
7.A patient who is able to operate the study's ePRO app
8.The principal investigator or sub-investigator has determined that weekly ePRO reporting can be continued

Exclude criteria

1.A patient with a complication or history of interstitial lung disease
2.A patient with a history of hypersensitivity to any of the ingredients in T-DXd
3.A patient deemed ineligible by the principal investigator or sub-principal investigator in accordance with the description in the T-DXd attachment
4. A patient who is judged by the principal investigator or sub-investigator to be unsuitable for outpatient chemotherapy due to complications or geographical factors.
5.A patient with multiple primary malignancies within 3 years
6.The principal investigator or sub-investigator determines that a patient is ineligible because of a mental illness that would affect the quality QOL assessment.
7. A patient who is receiving research drugs used in other study
8.A patient who is pregnant, lactating, or planning to become pregnant during the study
9.A patient who is judged by the principal investigator or sub- investigator to be ineligible for this research for any other reason.

Related Information

• Primary Sponsor: Sangai Takafumi
• Secondary Sponsor: Comprehensive Support Project for Oncological Research of Breast Cancer