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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02721641




Registration number
NCT02721641
Ethics application status
Date submitted
24/03/2016
Date registered
29/03/2016
Date last updated
31/03/2017

Titles & IDs
Public title
A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
Scientific title
A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors
Secondary ID [1] 0 0
2007-000348-28
Secondary ID [2] 0 0
BO15943
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Herceptin - Participants with stable disease and HER2-overexpressing metastatic or locally advanced cancer will receive expanded access to IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment.


Treatment: Drugs: Herceptin
Herceptin will be administered as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
On-Study Duration of Trial Treatment
Timepoint [1] 0 0
From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
Primary outcome [2] 0 0
Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)
Timepoint [2] 0 0
From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)
Primary outcome [3] 0 0
Number of Participants Withdrawn From Study Because of LVEF Dysfunction
Timepoint [3] 0 0
From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)

Eligibility
Key inclusion criteria
- Ongoing participants from any completed global Roche-sponsored Herceptin trial

- Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable
disease (or whose disease has not recurred) during Herceptin therapy at the end of the
lead-in trial

- Available study termination data (including tumor assessment and laboratory data) on
the Case Report Form for the lead-in trial

- Judged eligible by the investigator following a thorough risk/benefit assessment, if
signs of chronic heart failure developed during the lead-in trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or nursing women

- Women of childbearing potential unless using effective contraception as determined by
the investigator

- Severe dyspnea at rest requiring supplementary oxygen therapy

- Severe uncontrolled systemic disease

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 3
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
1/06/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Liverpool
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
4066 - Brisbane
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussel
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
France
State/province [3] 0 0
Marseille
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Göttingen
Country [6] 0 0
Germany
State/province [6] 0 0
Hamburg
Country [7] 0 0
Germany
State/province [7] 0 0
Heidelberg
Country [8] 0 0
Germany
State/province [8] 0 0
Lübeck
Country [9] 0 0
Germany
State/province [9] 0 0
Muenchen
Country [10] 0 0
Germany
State/province [10] 0 0
Trier
Country [11] 0 0
Guatemala
State/province [11] 0 0
Guatemala City
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Hungary
State/province [13] 0 0
Debrecen
Country [14] 0 0
Israel
State/province [14] 0 0
Ramat Gan
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Bundang City
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
Panama
State/province [18] 0 0
Panama City
Country [19] 0 0
Poland
State/province [19] 0 0
Gdansk
Country [20] 0 0
Portugal
State/province [20] 0 0
Lisboa
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Izhevsk
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Moscow
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Saint-Petersburg
Country [24] 0 0
Serbia
State/province [24] 0 0
Belgrade
Country [25] 0 0
Spain
State/province [25] 0 0
Alicante
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Edinburgh
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Glasgow
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Nottingham

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to provide continued access to intravenous (IV) Herceptin and to
evaluate long-term outcomes and overall safety in participants with stable disease and human
epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who
have completed a prior study with IV Herceptin.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02721641
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02721641