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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042866
Receipt No. R000048889
Scientific Title A Clinical Study to Explore Prediction of Response to Abemaciclib and Predictors of Intestinal Toxicity in ER-positive Metastatic Breast Cancer
Date of disclosure of the study information 2020/12/28
Last modified on 2020/12/28

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Basic information
Public title A Clinical Study to Explore Prediction of Response to Abemaciclib and Predictors of Intestinal Toxicity in ER-positive Metastatic Breast Cancer
Acronym A Clinical Study to Explore Prediction of Response to Abemaciclib and Predictors of Intestinal Toxicity in ER-positive Metastatic Breast Cancer
Scientific Title A Clinical Study to Explore Prediction of Response to Abemaciclib and Predictors of Intestinal Toxicity in ER-positive Metastatic Breast Cancer
Scientific Title:Acronym A Clinical Study to Explore Prediction of Response to Abemaciclib and Predictors of Intestinal Toxicity in ER-positive Metastatic Breast Cancer
Region
Japan

Condition
Condition ER-positive Metastatic Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to explore prediction of response to abemaciclib and predictors of intestinal toxicity in ER-positive metastatic breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes ・Time to Treatment Failure [ Time Frame: 2 years ]
・Incidence and severity of diarrhea [ Time Frame: Time Frame: 2 years ]
Key secondary outcomes Objective Response Rate [ Time Frame: 2 years ]
・Progression Free Survival (PFS) [ Time Frame: 2 years ]
・Overall Survival [ Time Frame: 2 years ]
・Disease Control Rate [ Time Frame: 2 years ]
・Clinical Benefit Rate [ Time Frame: 2 years ]
・Incidence of serious adverse events and other adverse events of special interest [ Time Frame: Time Frame: 2 years ]
・Change in predominant enterotypes and diversity of fecal microbiota
[ Time Frame: Gut microbiota will be analyzed at the beginning, after 3 months of intervention, and after disease progression]
・Correlation with Dietary habits [ Time Frame: Lifestyle will be analyzed at the beginning ]
・Correlation with Physical activity level
[ Time Frame: Lifestyle will be analyzed at the beginning ]
・Change in Tumor Immune microenvironment system
[ Time Frame: Tumor Immune microenvironment system will be analyzed at the beginning, after 3 months of intervention, and after disease progression]

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients must have histologically or cytologically confirmed invasive breast cancer, which is recurrent, unresectable or metastatic.
2) Either the primary tumor and/or metastatic tumor must be ER-positive on the most recent sample as defined below: Hormone receptor status: the invasive tumor must be ER- positive, or staining present in >=1% by immunohistochemistry (IHC)
3) HER2 status: the invasive tumor must be Human Epidermal Growth Factor Receptor 2-Negative (HER2-negative) by the ASCO CAP guideline.
4) Patients must have been judged by the treating physician to start administering abemaciclib
5) Prior biologic therapy: Patients must have discontinued all biologic therapy at least 21 days before registration.
6) Prior radiation therapy: Patients may have received prior radiation therapy in either the metastatic or early-stage setting. Radiation therapy must be completed at least 14 days prior to study registration.
7) Patients on bisphosphonates or RANK-L inhibitors may continue receiving these therapies during study treatment. There is no washout period required between the last dose of these therapies and the start of abemaciclib.
8) The patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
9) Patients must have normal organ and marrow function as defined below:
(1)Absolute neutrophil count >=1500/mm3
(2)Platelets >=100,000/mm3
(3)Hemoglobin >=8 g/dL
(4)Total bilirubin <=1.5x the upper limit of normal (ULN)
(5)Serum creatinine <=1.5 mg/dL OR calculated GFR >=60mL/min
(6)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3
times the upper limit of normal. For patients with documented liver
metastases, AST/ALT <= 5.0 times the upper limit of normal.
10) The patient must be >=20years old
11) Capable of understanding and complying with the protocol and has signed the informed consent document.
12) Able to swallow study drug.

Key exclusion criteria 1)Undergone major surgery within 14 days of the first dose of study drug.
2)Received another investigational agent within 14 days of the first dose of study drug. (Within 21 days for investigational agent with myelosuppressive agent.)
3)Received myelosuppressive chemotherapy for metastatic setting.
4)Has any severe concurrent disease that renders the patient inappropriate for enrollment in the opinion of the investigator.
5)Patients with active bacterial or fungal infections or detectable viral infections.
6)Documented brain metastases that are symptomatic, or require therapy to control symptoms. Patients who have completed treatment for brain metastasis such as surgery and radiation therapy and have no symptoms can be registered.
7)Pregnant women and lactating women are excluding from the study.
8)Individuals with a history of a second malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Patients with cervical cancer, or non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the principle investigator to determine eligibility.
9)Have been previously treated with palbociclib (excluding discontinuation due to toxicity)
10)Patients with constipation of Grade 2 or higher
11)The patient has serious uncontrolled preexisting medical condition(s) that in the judgement of the investigator, would preclude participation in this study (for example, severe renal impairment [e.g. estimated creatinine clearance <30ml/min],history of major surgical resection involving the stomach or small bowel, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
12)Patients with interstitial pneumonia.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Kawaguchi
Organization Kyoto University Hospital
Division name Breast Surgery Department
Zip code 606-8507
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507
TEL 075-751-3660
Email kkosuke@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Norihiko
Middle name
Last name Kitamura
Organization Kyoto Breast Cancer Research Network (KBCRN)
Division name Clinical Trial Management
Zip code 601-8001
Address Nakaya Building 1F, 1-10 Muromachi, Higashikujo, Minami-ku, Kyoto 601-8001
TEL 075-585-7861
Homepage URL
Email kitamura@kyoto-breast-cancer.org

Sponsor
Institute Kyoto Breast Cancer Research Network (KBCRN)
Institute
Department

Funding Source
Organization Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都大学医学部附属病院(京都府)
埼玉県立がんセンター(埼玉県)
社会医療法人博愛会 相良病院(鹿児島県)
社会医療法人神鋼記念会 神鋼記念病院(兵庫県)
公益財団法人 天理よろづ相談所病院(奈良県)
滋賀県立総合病院(滋賀県)
兵庫県立尼崎総合医療センター(兵庫県)
公益財団法人 田附興風会 医学研究所 北野病院(大阪府)
日本赤十字社 和歌山医療センター(和歌山県)
埼玉医科大学国際医療センター(埼玉県)


Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
2020 Year 12 Month 14 Day
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2024 Year 01 Month 31 Day
Date of closure to data entry
2024 Year 01 Month 31 Day
Date trial data considered complete
2024 Year 04 Month 30 Day
Date analysis concluded
2024 Year 07 Month 31 Day

Other
Other related information Study Design: Prospective cohort study
Among patients who decided to start treatment with abemaciclib will be included. Of these patients, those who have provided written informed consent will be registered.

Management information
Registered date
2020 Year 12 Month 28 Day
Last modified on
2020 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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