A single arm, multi-centre, international, continuation trial of recombinant humanized antibody Herceptin® (trastuzumab) in patients with HER2 overexpressing tumors.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000348-28-DE

Enrollment

Registered

2007-07-12

Start date

2007-08-30

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To continue to provide treatment to those patients that may still be on treatment at the moment of the final data base closure/clinical cut-off of a clinical trials in which Herceptin® is investigated and that further benefit from treatment with Herceptin®.

Interventions

Trade Name: Herceptin® Product Name: Herceptin Product Code: RO 45-2317 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Trastuzumab Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent 2. Ongoing patients from any completed global Roche Herceptin® sponsored trial. 3. Patients enrolled in any Roche Herceptin® study who have at least stable disease (or whose disease has not recurred) during Herceptin® therapy at the end of the lead-in trial. 4. Patient’s study termination data, including tumor assessment and laboratory data, have been collected on the Case Report Form (CRF) for the lead-in trials. 5. Patients who developed signs of chronic heart failure during the lead-in trial can only enter this protocol after a thorough risk/benefit assessment by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator. 2. Patients with severe dyspnea at rest requiring supplementary oxygen therapy. 3. Severe uncontrolled systemic disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To provide long term follow-up and safety data in patients receiving Herceptin® following completion of a global Roche sponsored Herceptin® trial.;Secondary Objective: ;Primary end point(s): • To provide Herceptin® to patients with HER2 overexpressing disease following completion of any global Roche sponsored Herceptin® study. • To follow long term outcomes in patients who are being treated with Herceptin®. • To follow long term overall safety with Herceptin®	—

Measure

Time frame

Main Objective: To provide long term follow-up and safety data in patients receiving Herceptin® following completion of a global Roche sponsored Herceptin® trial.;Secondary Objective: ;Primary end point(s): • To provide Herceptin® to patients with HER2 overexpressing disease following completion of any global Roche sponsored Herceptin® study. • To follow long term outcomes in patients who are being treated with Herceptin®. • To follow long term overall safety with Herceptin®

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Countries

France, Germany, Portugal

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026