JBCRG-M07(FUTURE)

JRCT ID: jRCTs021180028

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: advanced or metastatic HR-positive HER2-negative breast cancer
• Date of first enrollment: 17/01/2018
• Target sample size: 200
• Study type: Interventional

Intervention(s)

Additional palbpciclib after progression
to fulvestrant

Outcome(s)

• Primary Outcome: Progression-free survival: PFS

Secondary Outcome

Overall Survival
Overall response rate
Time to treatment failu re (TTF)
Safety
Transla tional Research

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Female

Include criteria

1st resistration
1.Historically co nfirm breast cancer
2.Age: 20-80years postmenopausal woman
3.HER2 negative
4.ER and/or PgR positive, HER2 negative
5.M etastatic or locally advanced breastcancer
6.Patients received Fulvestrant as 1stor 2nd line therapy
7.PS 0 - 2
8.Acceptab le for chemotherapy for neoadjuvant and adjuvant setting
9.Permit 1 line chemotherapy for metastatic breast cancer.
10.Permit 1 line horm one therapy formetastatic breast cancer before fulvestrant. (There are no including one linetrant. (There are no including one linethat stop or change hormone therapybefore resistant, such as switch TAM to AI, AI to TAM as adjuvant Tx, one year or more from stop adjuvant treatment, discontinue hormone therapy base on adverse event.)
11.Excepted that mor e than 3 monthoverall survival
12.No concern about measurable disease baced on RECIST
13.Meet the condition necessary for patients within 4 weeks before resistration
(1)N eutrophil count: >=1,500/mm3
(2)Platelet count: >=100,000/mm3
(3)Hemoglobin: >=9.0 g/dL
(4)Total bilirubin: <=1.5 mg/ dL
(5)AST(GOT), ALT(GPT): <=2.5 timesthe ULN (<=5 times in those with livermetastasis)
(6)Serum cre atinine: <=1.5 mg/dL
14.Informed consent is obtainable

2nd resistration
1.Patients have c onfirmed failure to Fulvestrant as 1st or 2nd line therapy
2.ECOG PS: 0-2
3.Excepted that m ore than 3 month overall survival
4.No concern a bout measurable disease baced on RECIST
5.Meet the condition necessary for patients within 4 weeks before resistration
(1)Neutrophil count: >=1,500/mm3
(2)Platelet count: >=100,000/mm3
(3)Hemoglobin: >=9.0 g/dL
(4)Total bilirubin: <=1.5 mg/dL
(5)AST(GOT), ALT(GPT): <=2.5 timesthe ULN (<=5 times in thosemetastasis) with liver
(6)Serum cre atinine: <=1.5 mg/dL
6.Having provided voluntary written consent for participation in this study.

Exclude criteria

1st resistration
1.Patients receiv ed CDK4/6 inhibitor a s metastatic therapy
2.Patients have confir med failure to Fulvestrant
3.Patients received antibiotics, antifun gal drug, antiviral drug and treatment for active infection of HBV and HCV.
4.Pregnancy or lactation
5.Brain metastasis and CNS metastatis
6.With another reasons recognized as inadequate to participate in this study by doctors

2nd resistration
1.Brain metastas is and CNS metastatis
2.With another reasons recognized as inadequate to participate in this study by doctors

Related Information

• Primary Sponsor: Watanabe Ken-ichi
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): UMIN000029294