Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

WiSP Wissenschaftlicher Service Pharma

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: paclitaxel plus trastuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01423695

WISP_RO78

Details and patient eligibility

About

The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed metastatic breast cancer overexpressing HER2
• pretreatment with anthracycline in either the adjuvant or palliative setting.
• HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
• informed consent

Exclusion criteria

• more than 1 chemotherapy for advanced disease
• taxane or trastuzumab pretreatment
• brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status >1
• pregnancy or lactation, childbearing potential without reliable contraception
• clinically significant cardiac disease,
• neutrophils <1500/µl, platelets <75,000/µl
• total bilirubin and creatinine >1.5 × the upper limit of normal

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

paclitaxel/trastuzumab

Experimental group

Description:

Single experimental arm in a phase II trial

Treatment:

Drug: paclitaxel plus trastuzumab