UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018202 |
|---|---|
| Receipt number | R000021051 |
| Scientific Title | A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer(Study of Perjeta re-treatment for clinical outcomes) |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2025/04/01 15:21:18 |
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Basic information
Public title
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer(Study of Perjeta re-treatment for clinical outcomes)
Acronym
JBCRG-M05(PRECIOUS)
Scientific Title
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer(Study of Perjeta re-treatment for clinical outcomes)
Scientific Title:Acronym
JBCRG-M05(PRECIOUS)
Region
| Japan |
Condition
Condition
HER2-positive locally advanced or metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer patients for previously treated with pertuzumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Progression-free survival (assessed by investigators)
Key secondary outcomes
PFS (assessed by independent review), PFS in patients treated with trastuzumab emtansine (T-DM1) as the latest regimen, Response rate, Duration of response, Overall survival (OS), Patient-reported-outcome (QOL), Safety, biomarkers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Trastuzumab + chemotherapy
Chemotherapy regimen is chosen from the following;
Docetaxel,Paclitaxel, nab-paclitaxel, vinorelbine, Eribulin, Capecitabine or Gemcitabine
Interventions/Control_2
Trastuzumab+ pertuzumab + chemotherapy
Chemotherapy regimen is chosen from the following;
Docetaxel, Paclitaxel, nab-paclitaxel, vinorelbine, Eribulin, Capecitabine or Gemcitabine
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
Female
Key inclusion criteria
1.Histologically or cytologically confirmed invasive breast cancer
2.A confirmed HER2-positive status assessed by means of immunohistochemical analysis(with 3+ indicating positive status)and/or in situ hybridization(with an amplification ratio>=2.0 indicating positive) by each institute
3.History of pertuzumab and trastuzumab-containing chemotherapy for locally advanced and metastatic breast cancer(2 or 3 regimen as previous chemotherapy regimen for locally advanced or metastatic breast cancer). The latest regimen before enrollment dose not include pertuzumab.
4.Patients have measurable and/or non-measurable disease according to RECIST ver1.1.
5.Female patients and aged >= 20 years.
6.Left Ventricular Ejection Fraction (LVEF) >= 50% at baseline (within 28 days before enrollment) as determined by either ECHO or MUGA
7. Eastern Cooperative Oncology Group performance status of 0,1 or 2.
8.Life expectancy of patients is expected at least 3 months.
9.Signed and written informed consent (approved by the Institutional Review Board or Independent Ethics Committee) is obtained before any study procedure.
Key exclusion criteria
1. Pts with >= 4 regimens of anticancer therapy for locally advanced/metastatic BC
2. Pts with non-hematologic toxicity of >= Grade 3 at enrollment
3. Pts with metastases to the central nervous system which are symptomatic or whose symptoms are difficult to be controlled
4. Pts with active multiple malignancy
5. Pts with the history of administration of any of the following cumulative doses of ATCs:
Doxorubicin > 360 mg/m2
Epirubicin > 720 mg/m2
Mitoxantrone > 100 mg/m2
If patients have been treated with 2 or more ATCs, the cumulative dose should not exceed 360 mg/m2 equivalent of doxorubicin
6. Pts with uncontrolled hypertensionor unstable angina
7. Congestive heart failure that meets the NYHA classification of 2 or higher, or clinically significant arrhythmia that requires TRT
8. Pts with a history of myocardial infarction w/in 6 mos before enrollment
9. Pts with dyspnea at rest due to complications of advanced malignant tumor
10. The test results w/in 28 days before enrollment show the organ dysfunction
11. Pts with severe uncontrolled systemic disease
12. Pts with paraneoplastic hypercalcemia that cannot be controlled with bisphosphonates or denosumab
13. Pts with > Grade 2 toxicity associated with radiotherapy for BC w/in 14 days before enrollment
14. Pts who are expected to need major surgery or major trauma w/in 28 days before enrollment or major surgery during the TRT
15. Women who are pregnant or positive in pregnancy test
16. Women who are lactating
17. Pts who received the study drug w/in 28 days before enrollment
18. Pts with active systemic infection or HIV infection
19. Pts who received IV antibiotics for infection w/in 14 days before enrollment
20. Pts who receives daily TRT with IV or oral administration of corticosteroids for long time over 3 mos
21. Pts with hypersensitivity to pertuzumab, trastuzumab, and chemotherapy to be used in combination in this study
22. Pts who are unable or unwilling to comply with the requirements of the protocol
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | 1)Hiroji 2)Yutaka |
| Middle name | |
| Last name | 1)Iwata 2)Yamamoto |
Organization
1)Aichi Cancer Center
2)Kumamoto University Hospital
Division name
1)Department of Breast Oncology 2)Department of Breast and Endocrine Surgery
Zip code
860-8556
Address
2)1-1-1 Chuo-ku, Honjo, Kumamoto City, Kumamoto JAPAN
TEL
096-373-5521
ys-yama@triton.ocn.ne.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
3rd Floor, Nihonbashikoamicho9-4, Chuo-ku, Tokyo JAPAN
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
kikaku@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
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
Certified Review Board of Aichi Cancer Center
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi
Tel
052-762-6111
crb@aichi-cc.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
(北海道)札幌医科大学、手稲渓仁会病院、北海道がんセンター、旭川医科大学、斗南病院、北海道大学 (青森県)弘前市立病院、青森県立中央病院 (岩手県)岩手医科大学 (宮城県)東北大学 (山形県)山形県立中央病院 (福島県)福島県立医科大学 (群馬県)群馬県立がんセンター、伊勢崎市民病院 (埼玉県)埼玉県立がんセンター、さいたま赤十字病院、埼玉メディカルセンター (千葉県)国立がん研究センター東病院 (東京都)東京都立駒込病院、東京西徳洲会病院、虎の門病院、杏林大学、がん研究会有明病院、順天堂医院、国立がん研究センター中央病院、東京共済病院、東京女子医科大学附属足立医療センター、東京女子医科大学 (神奈川県)神奈川県立がんセンター、北里大学、湘南記念病院、聖マリアンナ医科大学 (長野県)佐久医療センター (富山県)富山県立中央病院、富山大学 (福井県)福井赤十字病院、福井県立病院 (岐阜県)岐阜大学、朝日大学、大垣市民病院 (静岡県)浜松医療センター、静岡県立総合病院、藤枝市立総合病院 (愛知県)愛知県がんセンター、名古屋市立大学、名古屋大学、名古屋市立大学医学部附属西部医療センター、愛知医科大学 (三重県)市立四日市病院、三重大学 (滋賀県)滋賀県立総合病院 (京都府)京都府立医科大学 (大阪府)近畿大学、大阪急性期・総合医療センター、堺市立総合医療センター、大阪労災病院、関西電力病院、りんくう総合医療センター、八尾市立病院、大阪国際がんセンター、大阪南医療センター、大阪公立大学、松下記念病院、市立東大阪医療センター、大阪医療センター、市立貝塚病院、相原病院 (兵庫県)神戸市立医療センター中央市民病院、兵庫医科大学、兵庫県立がんセンター、関西労災病院、神鋼記念病院、兵庫県立尼崎総合医療センター (奈良県)大和高田市立病院 (和歌山県)和歌山医療センター (岡山県)岡山大学、岡山赤十字病院 (広島県)広島市立広島市民病院、県立広島病院、広島大学、呉医療センター (山口県)山口大学 (香川県)香川県立中央病院 (愛媛県)四国がんセンター、愛媛大学、松山赤十字病院 (福岡県)九州がんセンター、及川病院、久留米総合病院、九州医療センター (佐賀県)佐賀県医療センター好生館 (長崎県)長崎医療センター、長崎大学 (熊本県)熊本赤十字病院、熊本大学 (大分県)大分県立病院 (宮崎県)さがら病院宮崎 (鹿児島県)相良病院、鹿児島大学 (沖縄県)那覇市立病院、中頭病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
https://ascopubs.org/action/downloadSupplement?doi=10.1200%2FJCO-24-01673&file=protocol_JCO-24-01673
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1200/JCO-24-01673
Number of participants that the trial has enrolled
219
Results
Conlusion
Retreatment with the same dual HER2 blockade of pertuzumab plus trastuzumab could contribute to improving survival in patients who were previously treated with dual HER2 blockade using pertuzumab and trastuzumab as first- or second-line therapy for LA/mBC.
Results date posted
| 2025 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 24 | Day |
Baseline Characteristics
Patients with HER2-positive locally advanced/metastatic breast cancer previously treated with pertuzumab (previous treatment: 2 or 3 regimens)
Participant flow
At the data cutoff date on December 31, 2021, 211 eligible patients were randomly assigned between August 1, 2015, and December 31, 2018, with 110 patients in the PTC group and 109 patients in the TC group across 93 institutions in Japan. Of the 110 patients in the PTC group, two were excluded from the intention-to-treat (ITT) population (n = 108). For the independent reviewer-assessed population, 10 patients in the PTC group (n = 98) and four in the TC group (n = 105) were excluded.
Adverse events
As in the primary analysis, no differences in adverse events were observed in this update, except for a higher frequency of diarrhea in the PTC group.
Outcome measures
Results
In the updated analysis of investigator-assessed PFS, 94 patients (87.0%) in the PTC group and 96 patients (88.1%) in the TC group had PFS events. PTC showed improvement in median PFS (5.5 months [95% CI, 4.1 to 6.5]) compared with TC (4.2 months [95% CI, 3.2 to 4.8]; stratified HR, 0.81 [one-sided 95% CI upper limit, 1.02]).
For independent reviewer-assessed PFS, 66 patients (67.3%) in the PTC group and 72 patients (68.6%) in the TC group had PFS events, without difference between the groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021051
