ERICA

JRCT ID: jRCTs031210410

Registered date:04/11/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: HER2-positive or HER2-low metastatic breast cancer
• Date of first enrollment: 04/11/2021
• Target sample size: 166
• Study type: Interventional

Intervention(s)

Randomized Study
Experimental Arm:
5-HT3 receptor antagonist, dexamethasone, and olanzapine
Control Arm:
5-HT3 receptor antagonist, dexamethasone, and placebo

Outcome(s)

• Primary Outcome: Complete response (no emetic episodes and no use of rescue medication) during the delayed period (24-120h) as measured by the electronic symptom diary

Secondary Outcome

1. Complete response during the acute (0-24h), acute and delayed (0-120h), persistent (120-504h), and overall periods (0-504h) as measured by the electronic symptom diary
2. Complete control (no emetic episodes, no rescue medication, and mild nausea of 0or1/4) during the acute (0-24h), delayed (24-120h), acute and delayed (0-120h), persistent (120-504h), and overall periods (0-504h) as measured by the electronic symptom diary
3. Total control (no emetic episodes, no rescue medication, and no nausea) during the acute (0-24h), delayed (24-120h), acute and delayed (0-120h), persistent (120-504h), and overall periods (0-504h) as measured by the electronic symptom diary
4. No nausea (0/4) during the acute (0-24h), delayed (24-120h), acute and delayed (0-120h), persistent (120-504h), and overall periods (0-504h) as measured by the electronic symptom diary
5. Complete response per day
6. No nausea per day
7. QOL (EORTC QLQ-C30)
8. Diarrhea, constipation, abdominal pain, bloating, loss of appetite, fatigue, and insomnia as measured by patient reported outcomes
9. Safety

Key inclusion & exclusion criteria

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

Include criteria

1) Written consent obtained from the patient after an explanation of the study
2) At least 20 years old
3) Histologically confirmed invasive breast cancer
4) Have a diagnosis of HER2 positive (IHC3+ or ISH+) or HER2-low (IHC1+ or IHC2+/ISH-) breast cancer
5) Have an indication for T-DXd treatment and is scheduled to start the T-DXd treatment
6) Diagnosed with unresectable or distant metastatic breast cancer
7) Have no symptomatic brain metastases
8) Have no ascites or pleural effusion requiring puncture therapy
9) Have no gastrointestinal obstruction such as gastric pyloric stenosis or intestinal obstruction
10) ECOG Performance Status of 0 to 2
11) At least 7 days have elapsed since radiation and at least 14 days since chemotherapy or immunotherapy. Treatment-induced toxicity has decreased to Grade 1 or less before starting this study
12) Have no severe organ damage and meet the criteria.
13) HbA1c (NGSP) less than 6.5% at the time of enrollment and not receiving treatment with insulin or antidiabetic drugs
14) Have no active hepatitis B infection.
15) Be able to access the electronic symptom diary (ePRO) and accurately record their diary

Exclude criteria

1) Have a history of allergic reactions to the medications used in this study
2) With nausea and vomiting requiring treatment with antiemetic agents at the time of enrollment
3) Started strong opioid analgesics within 48 hours before enrollment
4) History of unstable angina pectoris, myocardial infarction, cerebral hemorrhage, or cerebral infarction within 6 months before enrollment
5) Complications or a history of interstitial lung disease
6) Pregnant women, lactating women, women who may be currently pregnant, or patients who do not intend to use contraception
7) Have a psychiatric condition that may increase the risk associated with study participation
8) Take a medication that is prohibited from regularly taking as specified in the protocol
9) Have local infections or active systemic infections that require treatment
10) Other conditions that would make the patient inappropriate for entry to this study in the judgment of the investigator

Related Information

• Primary Sponsor: Sakai Hitomi
• Source(s) of Monetary Support: DAIICHI SANKYO COMPANY, LIMITED