UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051096 |
|---|---|
| Receipt number | R000058218 |
| Scientific Title | Innovation of the 1st line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for HR-positive HER2-negative advanced metastatic breast cancer patients - Multi-institutional phase 2 trial |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2025/06/02 16:56:14 |
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Basic information
Public title
Innovation of the 1st line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for HR-positive HER2-negative advanced metastatic breast cancer patients - Multi-institutional phase 2 trial (JBCRG-M08)
Acronym
JBCRG-M08(AMBER trial)
Scientific Title
Innovation of the 1st line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for HR-positive HER2-negative advanced metastatic breast cancer patients - Multi-institutional phase 2 trial
Scientific Title:Acronym
JBCRG-M08(AMBER trial)
Region
| Japan |
Condition
Condition
Hormone receptor-positive, HER2-negative inoperable or recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore the efficacy of a treatment strategy to select an endocrine agent based on assessment of ESR1 mutation status by ctDNA analysis in patients who continue abemaciclib and aromatase inhibitor combination therapy for at least 6 months as first-line treatment for hormone receptor (HR)-positive, HER2-negative advanced metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year PFS rate from the secondary enrollment (all arms)
Key secondary outcomes
1. 2-year PFS rate after the secondary enrollment (each arm): Key Secondary End Point
2. Rate of disappearance of ESR1 mutations in ctDNA with FUL+ABE: Key Secondary End Point
3. PFS from the secondary enrollment (all arms and each arm)
4. PFS from FUL+ABE initiation (arm FUL+ABE, arm Re-AI+ABE, and both arms)
5. PFS with Re-AI+ABE (arm Re-AI + ABE)
6. Overall survival (OS) (all arms and each arm)
7. Response rate and disease control rate (all arms and each arm)
8. Safety
9. Protocol treatment compliance rate
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Based on the presence or absence of ESR1 mutation confirmed by "measurement for interventional ctDNA", the content of protocol treatment is continued or changed.
Interventions/Control_2
Based on the presence or absence of ESR1 mutation confirmed by "measurement for interventional ctDNA", the content of protocol treatment is continued or changed.
Interventions/Control_3
Based on the presence or absence of ESR1 mutation confirmed by "measurement for interventional ctDNA", the content of protocol treatment is continued or changed.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Inclusion criteria for primary enrollment
1. Histologically diagnosed with invasive breast cancer.
2. Confirmed ER-positive or PgR-positive.
3. Confirmed HER2-negative.
4. Diagnosed with advanced or metastatic breast cancer.
5. Age >=18 years at the time of informed consent.
6. Women in menopause lasting more than 3 months.
7. Performance status of 0 or 1
8. Aromatase inhibitor+abemaciclib combination therapy has been administered as the first-line treatment, and both drugs have been continued for >=6 to < 12 months at the time of the primary enrollment.
9. No evidence of progressive disease based on radiographic evaluation within 6 weeks before the day of enrollment.
10. No active interstitial pneumonia confirmed by CT within 6 weeks before the day of enrollment.
11. Non-hematologic toxicities (excluding alopecia) with aromatase inhibitor+abemaciclib combination therapy controlled at Grade <= 2.
12. Meeting the criteria in blood test within 28 days before the day of enrollment.
13. Patients who received chemotherapy must have recovered (Grade <=1)) . A washout period of at least 21 days is required between last chemotherapy dose and randomization.
14. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
15. The patient is able to swallow oral medications.
16. Written consent for participation has been obtained from the patient herself.
Inclusion criteria for secondary enrollment
1. Both aromatase inhibitor and abemaciclib have been continued after the primary enrollment and are expected to be continued thereafter.
2. No progression was confirmed by tumor evaluation at Week 12 after the primary enrollment.
3. Performance status (PS) of 0 or 1 according to the ECOG criteria.
4. The patient meets the following criteria in a blood test performed within 28 days before the day of secondary enrollment.
Key exclusion criteria
For primary enrollment
1. Patients with ILD/pneumonitits.
2. Patients with central nervous system metastases or carcinomatous meningitis.
3. Patients with active double cancer other than BC.
4. Patients with breast cancer other than hormone receptor-positive, HER2-negative one of synchronous or the disease-free period (< 5 years before the day of primary enrollment).
5. Patients with active systemic bacterial infection.
6. Patients with known infection with HBV or HCV or HIV.
7. Patients with a complication or history of heart failure of NYHA class II to IV, IHD, or arrhythmia requiring treatment.
8. Patients with syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin.
9. Patients with poorly controlled diabetes mellitus.
10. Patients with poorly controlled hypertension.
11. Patients with symptoms of dyspnea at rest.
12. Patients with pleural effusion, ascites, or cardiac effusion requiring drainage.
13. Women who intend to become pregnant, who cannot give consent for contraception, who are pregnant or lactating.
14. Patients who do not wish to continue ABEM.
15. Patients with major surgery within 14 days prior to randomization.
16. Patients with an experimental treatment in a clinical trial within the last 30 days or 5 half-lives in any other type of medical research.
17. Patients participating or planning to do in other clinical researches.
18. Patients with a history of hypersensitivity to letrozole, anastrozole, fulvestrant, or ABEM or to leuprorelin or goserelin.
19. Patients with serious and/or uncontrolled preexisting medical condition(s) in the judgement of the investigator.
20. Patients judged by the investigator or subinvestigator to be inappropriate to participate in this research.
For secondary enrollment
1. Patients with active infection requiring systemic treatment.
2. Patients unwilling to continue abemaciclib.
3. Patients judged by the investigator or subinvestigator to be inappropriate to continue this research.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshinami |
Organization
Osaka University Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
565-0871
Address
2-15 Yamadaok, Suita-shi, Osaka, Japan
TEL
06-6879-5111
yosinami-te@onsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
Japan Breast Cancer Research Group (JBCRG)
Division name
Head Office
Zip code
103-0016
Address
9-4-3F, Nihonbashi, Koamicho, Chuo-ku, Tokyo, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
JBCRG-QAG@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
Jun Fukase
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8270
handai-nintei@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs051220133
Org. issuing International ID_1
jRCT(Japan Registry of Clinical Trials)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院（大阪府）名古屋大学医学部附属病院（愛知県）、名古屋徳洲会総合病院（愛知県）、青森県立中央病院（青森県）、名古屋医療センター（愛知県）、岐阜大学医学部附属病院（岐阜県）、山口大学医学部附属病院（山口県）、富山大学附属病院（富山県）、八尾市立病院（大阪府）、県立広島病院（広島県）、大阪赤十字病院（大阪府）、日本赤十字社愛知医療センター名古屋第二病院（愛知県）、埼玉医科大学国際医療センター（埼玉県）、東京大学医学部附属病院（東京都）、市立貝塚病院（大阪府）、三重大学医学部附属病院（三重県）、秋田大学医学部附属病院（秋田県）、がん研究会有明病院（東京都）、関西医科大学附属病院（大阪府）、日本赤十字社愛知医療センター名古屋第一病院（愛知県）、大阪国際がんセンター（大阪府）、福島県立医科大学附属病院（福島県）、広島大学病院（広島県）、東北大学病院（宮城県）、筑波大学附属病院（茨城県）、山形大学医学部附属病院（山形県）、京都大学医学部附属病院（京都府）、九州がんセンター（福岡県）、国立がん研究センター東病院（千葉県）、東京女子医科大学病院（東京都）、兵庫県立尼崎総合医療センター、熊本大学病院（熊本県）、神鋼記念病院（兵庫県）、浜松医科大学医学部附属病院（静岡県）、札幌医科大学附属病院（北海道）、昭和大学病院（東京都）、愛媛大学医学部附属病院（愛媛県）、群馬大学医学部附属病院（群馬県）、弘前大学医学部附属病院（青森県）、長崎大学病院（長崎県）、北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058218
