A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Taxane (docetaxel or paclitaxel); Drug: Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475670

WO17299

Details and patient eligibility

About

This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
• metastatic breast cancer >=12 months after discontinuation of Herceptin;
• measurable disease.

Exclusion criteria

• previous chemotherapy for metastatic breast cancer;
• brain metastases;
• invasive malignancy other than metastatic breast cancer.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Trastuzumab Monotherapy

Active Comparator group

Description:

Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose on Day 1, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.

Treatment:

Drug: Trastuzumab

Trastuzumab, Taxane

Experimental group

Description:

Participant received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death; and concomitant taxane, which is either 100 milligrams per square meter (mg/m2) docetaxel i.v. every 3 weeks, or 75 mg/m2 weekly or 175 mg/m2 every 3 weeks paclitaxel for at least 18 weeks, or more at the discretion of the investigator.

Treatment:

Drug: Trastuzumab

Drug: Taxane (docetaxel or paclitaxel)