A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Xeloda; Drug: Taxotere; Drug: Herceptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02748213

MO16419

Details and patient eligibility

About

This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

Enrollment: 225 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy
• At least one measurable lesion according to RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Baseline left ventricular ejection fraction (LVEF) at least 50%

Exclusion criteria

• Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods
• Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease
• Past medical history significant for any cardiac or central nervous system (CNS) disorders
• Poor hematologic, renal, or hepatic function
• Chronic corticosteroid therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Herceptin + Taxotere

Experimental group

Description:

Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.

Treatment:

Drug: Herceptin

Drug: Taxotere

Herceptin + Taxotere + Xeloda

Experimental group

Description:

Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.

Treatment:

Drug: Xeloda

Drug: Herceptin

Drug: Taxotere