Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Disease Progression

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Antineoplastic Agents, Immunological

Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks.

Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.

trastuzumab

Clinical Trials

This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.

A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

An Open-label Pilot Study of the Effect of Second-line Treatment With Herceptin Monotherapy on Time to Disease Progression in Patients With Metastatic Urothelial Cancer and HER2 Overexpression

PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.

The median time, in months, from the first study drug treatment to a PFS event.

OS was defined as the time from the start of study treatment to date of death due to any cause.

The median time, in months, from the start of study treatment to an OS event.

Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal \[(short axis less than (\<)10 millimeters (mm)\]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD).

Hoffmann-La Roche

All enrolled participants were included in the safety analysis.

Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.

Trastuzumab Monotherapy

Age, Continuous

Sex: Female, Male

Full analysis set (FAS) includes all participants who received study treatment.

Medical Communications

Progression-Free Survival (PFS) - Percentage of Participants With an Event

Overall Survival (OS) - Percentage of Participants With an Event

Overall Survival - Time to Event

12 Months

24 Months

Percentage of Participants Surviving at 12 and 24 Months

Progression-Free Survival - Time to Event

SD/PD

Percentage of Participants by Best Overall Response to Treatment

Percentage of Participants Progression Free at 12 and 24 Months

Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.

Spots Global Cancer Trial Database for A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial