Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

NCT01423695 | Completed Phase 2

• 1 other identifier: WISP_RO78
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Patient follow-up on average for 15 months and up to a maximum of 51 months

Study Arms (1)

paclitaxel/trastuzumab

EXPERIMENTAL

Single experimental arm in a phase II trial

Drug: paclitaxel plus trastuzumab

Interventions

paclitaxel plus trastuzumab DRUG

Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression)

paclitaxel/trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• WiSP Wissenschaftlicher Service Pharma GmbH: lead
• Bristol-Myers Squibb: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Dr. Matthias John

Glauchau, Saxony, D-08371, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Matthias John, MD

  Oncology Practice, Glauchau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 26, 2011
• Study Start: February 1, 2001
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 26, 2011

Record last verified: 2011-08

Locations

DE (1)