UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014649 |
|---|---|
| Receipt number | 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 | 2021/07/30 11:15:28 |
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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 | 1)Masakazu 2) Norikazu |
| Middle name | |
| Last name | 1)Toi 2) Masuda |
Organization
1) Graduate School of Medicine Kyoto University
2) National Hospital Organization Osaka National Hospital
Division name
1)Breast Surgery, 2) Department of surgery, Breast oncology
Zip code
606-8507
Address
54,Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
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
https://www.jbcrg.jp/
neopeaks_office@umin.ac.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
N/A
Address
N/A
Tel
N/A
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
Main results already published
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
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016961
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