A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer

Plain-language summary

This study evaluates Herceptin (Trastuzumab) with standard therapy, along with biomarkers (disease-related markers), in patients with HER2-positive metastatic breast cancer. It included women over 18 with at least one metastatic site suitable for biopsy. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Hoffmann-La Roche

Intervention

Standard taxane therapy, capecitabine [Xeloda], trastuzumab [Herceptin]

Start date

8/13/2009

Estimated completion

2/18/2013

Countries

Australia, Spain, Sweden, United Kingdom

Related genes

Locations

• Camperdown, Australia
• St Leonards, Australia
• East Ringwood, Australia
• Wodonga, Australia
• Perth, Australia
• Perth, Australia
• Santander, Spain
• Valencia, Spain
• Stockholm, Sweden
• Uppsala, Sweden
• Hull, United Kingdom
• Manchester, United Kingdom
• Nottingham, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* female patients, \>=18 years of age;
* HER2-positive breast cancer;
* al least one metastatic site amenable for core biopsy;
* left ventricular ejection fraction \>50%.

Exclusion Criteria:

* prior adjuvant/neoadjuvant Herceptin within past 6 months;
* prior adjuvant taxane therapy within past 12 months;
* use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
* known bleeding diatheses.