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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014649
Receipt No. R000016961
Scientific Title A randomized, multicenter, phase II trial comparing neo-adjuvant therapy using pertuzumab and trastuzumab emtansine based on the dual HER2 blockade in patients with operable HER2-positive primary breast cancer(Neo-peaks study)
Date of disclosure of the study information 2014/08/01
Last modified on 2019/09/05

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Basic information
Public title A randomized, multicenter, phase II trial comparing neo-adjuvant therapy using pertuzumab and trastuzumab emtansine based on the dual HER2 blockade in patients with operable HER2-positive primary breast cancer(Neo-peaks study)
Acronym JBCRG-20 (Neo-peaks study)
Scientific Title A randomized, multicenter, phase II trial comparing neo-adjuvant therapy using pertuzumab and trastuzumab emtansine based on the dual HER2 blockade in patients with operable HER2-positive primary breast cancer(Neo-peaks study)
Scientific Title:Acronym JBCRG-20 (Neo-peaks study)
Region
Japan

Condition
Condition Female patients with operative HER2 positive primary breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study the best pre-operative therapy using the combination of anti-HER2 monoclonal antibodies in terms of efficacy and safety for patients with HER2-possitive primary breast cancer.
To compare the efficacy and safety between two different treatment regimens: docetaxel/carboplatin + trastuzumab + pertuzumab versus docetaxel/carboplatin + trastuzumab + pertuzumab followed by trastuzumab emtansine (T-DM1) + pertuzumab.
Additionally, to examine the efficacy and safety of the combination of T-DM1 + pertuzumab, and to evaluate pre-operative anti-HER2 therapy according to response.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes pCR
Key secondary outcomes SpCR, SpCR and ypN0 rate
CpCR rate
QpCR, QpCR and ypN0 rate
Overall response rate (ORR)
Breast-conserving surgery rate, and the proportion of breast-conserving surgery rate in patients who planned for mastectomy.
The proportion of patients not requiring lymph node dissection.
Disease-free survival and Progression-free survival
Overall Survival
To evaluate the safety profiles of each arm as follows;
Adverse events
Incidence of cardiac dysfunction

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 considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A (3 weeks *6)
PER: 840mg (initial)
420mg (maintenance)
HER: 8mg (initial), 6mg(maintenance)
DOC: 75 mg/m2, CBDCA: AUC6
Interventions/Control_2 Group B
1~4cycle (3 weeks x 4)
PER: 840mg (initial)
420mg (maintenance)
HER: 8mg (initial), 6mg(maintenance)
DOC: 75 mg/m2, CBDCA: AUC6
・5~8 cycle (3 weeks x4)
PER: 420mg, T-DM1: 3.6 mg/kg
If ER is positive,
Premenopausal: LH-RH analog + Tamoxifen
Postmenopausal: letrozole
Interventions/Control_3 Group C
1~4cycle (3 weeks x 4)
PER: 840mg (initial)
420mg (maintenance)
T-DM1: 3.6 mg/kg
If ER is positive,
Premenopausal:
LH-RH analog + Tamoxifen
Postmenopausal: letrozole
Cycle #3 Tissue biopsy
Cycle #4 Clinical antitumor effect measurement
5~6 cycle
If cCR, cPR and Ki67 =< 10%, and no cPR and infiltrating cancer or no cSd and infiltrating cancer,
PER: 420mg, T-DM1: 3.6 mg/kg
If ER is positive,
Premenopausal: LH-RH analog + Tamoxifen
Postmenopausal: letrozole
If cPD or cSD and infiltrating cancer or cPR and Ki67 > 10%, FEC therapy
Fluorouraci: 500 mg/m2
Epirubicin: 100 mg/m2
Cyclophosphamide: 500 mg/m2
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
70 years-old >=
Gender Female
Key inclusion criteria First key inclusion criteria
1)Age between 20 and 70 years
2)Female patients with primary breast cancer which is diagnosed as invasive cancer by needle biopsy or tissue biopsy.
3)Resectable primary breast cancer (cT1c-cT3,cN0-cN1,cM0)with a tumor size <=7cm in diameter.
4)The invasive component of the primary tumor is confirmed as HER2 positive(IHC 3+ or FISH+)
5)ER and PgR statuses are confirmed by IHC
6)No previous therapy for breast cancer
7)Pt has been confirned as suitable indication for primary systemic therapy
8)Pt who are able to undergo imaging evaluation of their primary disease using the same modality of contrast-enhanced MRI or PET/CT before the treatment,during the treatment,and at the end of the treatment.
9)Pt with evaluable primary disease using mammary ultrasonography before the treatment,during the treatment,and at the end of the treatment.
10)Written informed concents
Secondary criteria
By the pathological central review, HER2-positive invasive ductal carcionma, estrogen receptor and the Ki67 level has been confirmed.
1)ECOG performance status(PS)0-1
2)Laboratory test results meet the criteria
3)Baseline LVEF=>55% measured by echocardiography or MUGA scan.
4)No QTc prolongation by ECG
5)No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan
6)Pt with confirmed menopausal status.
7)Pt who are not pregnant or who are confirmed not to be pregnant by pregnancy test(excluding patients who had hysterectomy).
8)Fertile patients must agree to use one"highly effective"form of nonhormonal contraception or two "effective" forms of nonhormonal contraception while on study and for more than 7 months after end of study treatment.
9)Pt with a positive hepatitis B surface antigen HBs antigen-positive patients cannot be enrolled.
Key exclusion criteria 1) Bilateral breast cancer whether synchronous or metachronous.Patients with controllable LCIS are permitted.
2)Pt with axillary lymph node dissection before pre-operative chemotherapy.
3)Pt with incisional or excisional biopsies for primary disease or axillary lymph node.
4)Pt with multiple malignancies.
5)Participation in another clinical trial
6)Pt with peripheral neuropathy >=NCI CTCAE v4.03 Grade 2 are excluded.
7)Pt with known cardiopulmonary dysfunction within 6 months before the 2nd enrollment are excluded
-Symptomatic left ventricular systolic dysfunction, severe cardiac arrhythmia uncontrolled by appropriate treatments.
-High-risk uncontrolled arrhythmias
-Uncontrolled hypertension,angina pectoris, clinically significant valvular heart disease.
-Requires continuous oxygen inhalation therapy.
-History of symptomatic congestive heart failure according to NCI CTCAE v4.03 or NYHA classification.
8)Pt with a history of myocardial infarction within 12 months before the 2nd enrollment.
9)Pt with severe uncontrolled systemic disease
10)Pt who have undergone major surgical operations or significant trauma within 28 days before the 2nd enrollment,or who have planned a major surgical operation during this study.
11)Pt with severe infectious disease requiring intravenous administration of antibiotics, antiviral agents,or antifungal agents at enrollment.
12)Pt with dental caries and/or oral infections requiring treatment.
13)Pt with diagnosed of active liver disease caused by autoimmune disease or sclerosing cholangitis.
14)Pt with obvious HIV infections.
15)Pt who are breast feeding.
16)History of uncontrolled seizures,central nervous system disorders,and mental disorders. Pt with diseases that could interfere with the informed consent process and/or compliance with protocol-based procedures as judged by investigator.
17)Known hypersensitivity to any of the study drugs or additives,including murine proteins.
18)Pt considered unfit as judged by the investigator.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Masakazu
Middle name
Last name Toi
Organization Graduate School of Medicine Kyoto University
Division name Department of Surgery (Breast Surgery)
Zip code 606-8507
Address 54,Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Email neopeaks_office@umin.ac.jp

Public contact
Name of contact person
1st name Hiroi
Middle name
Last name Kasai
Organization Kyoto University Hospital
Division name Institute for Advancement of Clinical and Translational Science
Zip code 606 8507
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-4722
Homepage URL
Email neopeaks_office@umin.ac.jp

Sponsor
Institute Japan Breast Cancer Research Group(JBCRG)
Institute
Department

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 N/A
Address N/A
Tel N/A
Email N/A

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW 20040213/20090630 8回/8回 

Institutions
Institutions 岩手医科大学附属病院 (岩手県)
群馬県立がんセンター(群馬県)
筑波大学附属病院 (茨城県)
埼玉県立がんセンター(埼玉県)
千葉県がんセンター(千葉県)
日本大学医学部附属板橋病院(東京都)
虎の門病院(東京都)
都立駒込病院 (東京都)
公益財団法人 がん研究会有明病院(東京都)
国立がん研究センター中央病院(東京都)
地方独立行政法人神奈川県立病院機構神奈川県立がんセンター(神奈川県)
京都大学医学部附属病院(京都府)
独立行政法人 国立病院機構大阪医療センター(大阪府)
地方独立法人 広島市民病院機構 広島市立広島市民病院 (広島県)
独立行政法人国立病院機構 四国がんセンター(愛媛県)
独立行政法人 国立病院機構 九州がんセンター(福岡県)
愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 236
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
2014 Year 05 Month 20 Day
Date of IRB
2014 Year 06 Month 17 Day
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2021 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
2014 Year 07 Month 25 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016961

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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