Chloe trial

JRCT ID: jRCTs061180075

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Metastatic Braest Cancer
• Date of first enrollment: 29/05/2017
• Target sample size: 130
• Study type: Interventional
• Intervention(s): Additional evelolimus

Outcome(s)

• Primary Outcome: progression-free survival, PFS
• Secondary Outcome: Overall survival (OS); response rate (RR); disease control rate (DCR); adverse events; time to treatment failure (TTF); and the proportion of patients who continued administration of AI agents for 1 year after the randomized allocation.

Key inclusion & exclusion criteria

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

Include criteria

1, Patients who are histologically diagnosed as having breast cancer.
2, The cancer is immunohistochemically ER-positive (>10%) and HER2- negative (0/1+) (or HER2-negative based on ISH testing).
3, Patients who have one or more measurable lesions according to RECIST (Ver. 1.1).
As for bone lesions, patients who have measurable osteolytic or osteolytic osteoblastic lesions by CT or MRI (> 1cm in length) are eligible.
4, Patients with metastatic breast cancer that satisfy one of following two conditions:
1) Patients with remote metastasis judged not to be indicated for surgical resection at the first visit.
2) Patients with metastatic breast cancer except for local recurrence (the term local here refers to the chest wall surrounded by the following areas: upward to subclavian margin, downward to costal arch, inward to medial sternal margin and outward to the frontal margin of latissimus dorsi muscle). Patients with local recurrence which is not indicated for surgical resection due to diffuse lesions are eligible.
5, If patients received post-operative endocrine therapy, a 12 month or longer period must have passed since the end of the last administration. History of post-operative chemotherapy and elapsed time from chemotherapy, as well as the regimen of post-operative endocrine therapy, do not matter.
6, Among patients who start the treatment with an AI agent within 5-7 months previously. Patients who have not received chemotherapy or received just 1 regimen of chemotherapy.
7, Patients who have no history of treatment with everolimus.
8, Patients who are post-menopausal women.
9, Patients with ECOG performance status (PS) of 0 or 1. Patients with PS2 due to bone metastasis is allowed.
10, If patients have received radiation therapy, a 14 day or longer period must have passed since the end of the last radiation session.
11, Adequate organ functions.
12, Written informed consent.

Exclude criteria

1, Patients who have active double cancer (simultaneous double cancer or metachronous double cancer within 5 years of disease-free period). Carcinoma in situ (intraepithelial carcinoma and mucosal carcinoma) that is judged to be already cured will not be classified as active double cancer
2, Patients who have a history of serious drug hypersensitivity.
3, Patients who have serious concomitant diseases (including pulmonary fibrosis or interstitial pneumonia, uncontrollable diabetes, serious cardiac dysfunction, renal failure, hepatic insufficiency, cerebrovascular disease and ulcer(s) requiring a blood transfusion).
4, Patients who have an active infectious disease requiring systemic treatment.
*Patients who are HBs antigen positive and HBc antibody positive, and/or HBs antibody positive.
*Patients who are infected with HCV or have a history of HCV infection.
5, Patients who have active hemorrhagic diathesis or who are being treated with an oral vitamin K antagonist
6, Patients with cerebral metastasis that is symptomatic or requires treatment.
7, Patients who have been administered medicines known as potent CYP3A inhibitors or CYP3A inducers (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin).
8, Patients who have been treated with hormone replacement therapy.
9, Patients who have a mental disorder that affects the informed consent process.
10, Patients who are judged to be inappropriate to participate in this study on the basis of physician's assessment.

Related Information

• Primary Sponsor: Shien Tadahiko
• Source(s) of Monetary Support: Novartis,NOVARTIS
• Secondary ID(s): UMIN000025156