Clinical trial NCT02721641: A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
Official title: A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-29
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: On-Study Duration of Trial Treatment
timeFrame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
measure: Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)
timeFrame: From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)
measure: Number of Participants Withdrawn From Study Because of LVEF Dysfunction
timeFrame: From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: Australia
state: New South Wales
city: Waratah
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Brisbane
country: Australia
state: Queensland
city: Fitzroy
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Brussel
country: Belgium
city: Beijing
country: China
city: Beijing
country: China
city: Marseille
country: France
city: Berlin
country: Germany
city: Göttingen
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Lübeck
country: Germany
city: Muenchen
country: Germany
city: Muenchen
country: Germany
city: Trier
country: Germany
city: Guatemala City
country: Guatemala
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Ramat Gan
country: Israel
city: Bundang City
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Auckland
country: New Zealand
city: Panama City
country: Panama
city: Gdansk
country: Poland
city: Lisboa
country: Portugal
city: Izhevsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Belgrade
country: Serbia
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Muller V, Clemens M, Jassem J, Al-Sakaff N, Auclair P, Nuesch E, Holloway D, Shing M, Bang YJ. Long-term trastuzumab (Herceptin(R)) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018 Mar 15;18(1):295. doi: 10.1186/s12885-018-4183-2.