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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00545688




Registration number
NCT00545688
Ethics application status
Date submitted
16/10/2007
Date registered
17/10/2007
Date last updated
15/08/2017

Titles & IDs
Public title
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
Scientific title
A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer
Secondary ID [1] 0 0
WO20697
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Herceptin
Treatment: Drugs - Docetaxel
Treatment: Drugs - Pertuzumab

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Experimental: 4 -


Treatment: Drugs: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly

Treatment: Drugs: Docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

Treatment: Drugs: Pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Pathological Complete Response (pCR)
Timepoint [1] 0 0
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
Primary outcome [2] 0 0
Percentage of Participants Achieving pCR by Breast Cancer Type
Timepoint [2] 0 0
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
Primary outcome [3] 0 0
Percentage of Participants Achieving pCR by Hormone Receptor Status
Timepoint [3] 0 0
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
Primary outcome [4] 0 0
Percentage of Participants Achieving pCR by Lymph Node Status
Timepoint [4] 0 0
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
Primary outcome [5] 0 0
Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS)
Timepoint [5] 0 0
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
Secondary outcome [1] 0 0
Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography
Timepoint [1] 0 0
Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [2] 0 0
Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography
Timepoint [2] 0 0
Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [3] 0 0
Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination
Timepoint [3] 0 0
Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [4] 0 0
Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination
Timepoint [4] 0 0
Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [5] 0 0
Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography
Timepoint [5] 0 0
Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [6] 0 0
Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination
Timepoint [6] 0 0
Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [7] 0 0
Time to Clinical Response During Neo-Adjuvant Treatment Period
Timepoint [7] 0 0
Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [8] 0 0
Percentage of Participants With Progressive Disease During Neo-Adjuvant Treatment Period
Timepoint [8] 0 0
Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
Secondary outcome [9] 0 0
Percentage of Participants Achieving Breast Conserving Surgery For Whom Mastectomy Was Planned
Timepoint [9] 0 0
Surgery (Within 2 weeks after Cycle 4) Up to approximately 24 months
Secondary outcome [10] 0 0
Percentage of Participants Who Were Progression Free and Disease Free
Timepoint [10] 0 0
Randomization up to a maximum of 329 weeks
Secondary outcome [11] 0 0
Progression Free and Disease Free Survival
Timepoint [11] 0 0
Randomization up to a maximum of 329 weeks

Eligibility
Key inclusion criteria
* female patients, >=18 years of age;
* locally advanced, inflammatory or early stage invasive breast cancer;
* HER2 positive (HER2+++ by IHC or FISH/CISH+).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* metastatic disease (Stage IV) or bilateral breast cancer;
* previous anticancer therapy or radiotherapy for any malignancy;
* other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
* insulin-dependent diabetes;
* clinically relevant cardiovascular disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2014
Sample size
Target
Accrual to date
Final
417
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Geelong Hospital; Andrew Love Cancer Centre - Geelong
Recruitment hospital [2] 0 0
Mount Medical Center - Perth
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Brazil
State/province [3] 0 0
RS
Country [4] 0 0
Brazil
State/province [4] 0 0
SC
Country [5] 0 0
Brazil
State/province [5] 0 0
SP
Country [6] 0 0
Canada
State/province [6] 0 0
New Brunswick
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Israel
State/province [9] 0 0
Jerusalem
Country [10] 0 0
Israel
State/province [10] 0 0
Kfar-Saba
Country [11] 0 0
Israel
State/province [11] 0 0
Tel Aviv
Country [12] 0 0
Italy
State/province [12] 0 0
Emilia-Romagna
Country [13] 0 0
Italy
State/province [13] 0 0
Friuli-Venezia Giulia
Country [14] 0 0
Italy
State/province [14] 0 0
Lombardia
Country [15] 0 0
Italy
State/province [15] 0 0
Veneto
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Mexico
State/province [17] 0 0
Aguascalientes
Country [18] 0 0
Mexico
State/province [18] 0 0
Mexico City
Country [19] 0 0
Mexico
State/province [19] 0 0
Puebla
Country [20] 0 0
Peru
State/province [20] 0 0
Arequipa
Country [21] 0 0
Peru
State/province [21] 0 0
Lima
Country [22] 0 0
Poland
State/province [22] 0 0
Lublin
Country [23] 0 0
Poland
State/province [23] 0 0
Olsztyn
Country [24] 0 0
Poland
State/province [24] 0 0
Poznan
Country [25] 0 0
Poland
State/province [25] 0 0
Warszawa
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Leningrad
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Kazan
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Petrozavodsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Pyatigorsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Ryazan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Samara
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Soshi
Country [34] 0 0
Russian Federation
State/province [34] 0 0
St Petersburg
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Ulyanovsk
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Vizcaya
Country [38] 0 0
Spain
State/province [38] 0 0
Cordoba
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Spain
State/province [41] 0 0
Zaragoza
Country [42] 0 0
Sweden
State/province [42] 0 0
Stockholm
Country [43] 0 0
Sweden
State/province [43] 0 0
Uppsala
Country [44] 0 0
Switzerland
State/province [44] 0 0
Baden
Country [45] 0 0
Switzerland
State/province [45] 0 0
Zürich
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei
Country [47] 0 0
Thailand
State/province [47] 0 0
Bangkok
Country [48] 0 0
Thailand
State/province [48] 0 0
Songkhla
Country [49] 0 0
Turkey
State/province [49] 0 0
Izmir
Country [50] 0 0
Turkey
State/province [50] 0 0
Sihhiye, ANKARA
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Coventry
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00545688