Comparing Eribulin with S1, to assess HRQoL in Her2 negative Metastatic Breast Cancer Patients: RESQ

JRCT ID: jRCTs011180026

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: metastatic breast cancer
• Date of first enrollment: 13/06/2016
• Target sample size: 330
• Study type: Interventional
• Intervention(s): The CSPOR Data Center will confirm patient eligibility, and treatment will be automatically assigned either Eribulin or S1 according to the assignment adjustment factors for eligible patients. The following 5 variables will be used as assignment adjustment factors: hospital, age, first line or second, hormone sensitivity, and the period from the date of surgery to the date of recurrence

Outcome(s)

• Primary Outcome: Health related Quality of Life (HRQoL)
• Secondary Outcome: overall survival (OS), progression free survival (PFS), time to treatment failure (TTF), new metastatic free survival (nMFS), adverse events, patient preference, cost-effectiveness, and QoL other than HRQoL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

(i) Women with a histologically confirmed diagnosis of breast cancer.
(ii) One of the following conditions has to be met for a diagnosis of metastatic breast cancer.
(a) At the diagnosis of breast cancer, the patient has both primary breast cancer and distant metastasis (STAGE IV).
(b) The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and pre- and post- operative treatment); however, local recurrence is excluded
(iii) Chemotherapy is scheduled for the treatment of metastatic breast cancer.
(iv) A performance status of 0-1 according to the ECOG scale.
(v) Patients must have measurable disease or evaluable non-measurable disease.
(vi) All of the following conditions have to be met regarding organ function (within 14 days before registration).
(a) A neutrocyte count of 1,500/mm3 or higher
(b) A platelet count of 100,000/mm3 or higher.
(c) A hemoglobin count of 9.0 g/dL or higher
(d) Aspartate aminotransferase (AST, GOT) and alanine aminotransferase concentrations (ALT, GPT) of not more than 100 IU/L (When a patient has liver metastasis, this limitation sets it with 150 IU/L in particular )
(e) Total serum bilirubin of not more than 2.1 mg/dL
(f) A serum creatinine concentration of not more than 1.6 mg/dL. And creatinine clearance of 50 mL or higher, too
(vii) Hormone therapy,radiotherapy and chemotherapy: at least 14 days have elapsed. Surgery: at least 28 days have elapsed.
(viii) An age of 20-75 years.
(ix) Patient who can observe a treatment plan, periodical inspection, QoL evaluation and other procedures.
(x) Patient whom survival more than six months is expected of.
(xi) Written informed consent has been obtained directly from the subject

Exclude criteria

(i) Overexpression of human epidermal growth factor receptor 2 (Her2), or the results of in situ hybridization are positive.
(ii) Patient has received more than two chemotherapy line for metastatic disease.
(iii)Patient has received eribulin or S-1.
(iv) Patient has more than CTCAE grade 3 anxiety at enrollment.
(v) The presence of interstitial pneumonia or pulmonary fibrosis.
(vi) The presence of cardiac conduction abnormality (heart failure, ischemic heart disease)
(vii) The presence of pleural effusion, ascites or pericardial effusion requiring tubing or emergency treatment.
(viii)Patient has to receive systemic steroid treatment continuously.
(xi) The presence of severe allergic reaction
(x) Women who are pregnant, breast feeding or intend to become pregnant.
(xi) The presence of uncontrollable brain metastasis or meningitis.
(xii)The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less, excluded in situ lesion or mucosal lesion).
(xiii) bilateral breast cancer (excluded DCIS or corresponding ER and HER2 status)

Related Information

• Primary Sponsor: WATANABE KENICHI
• Source(s) of Monetary Support: Eisai
• Secondary ID(s): UMIN000021398