CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Nab-paclitaxel 125 mg/m² IV over 30 minutes on days 1 and 8 of 21-day cycle; gemcitabine 1000 mg/m² IV over 30 minutes on days 1 and 8 of 21-day cycleAI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed invasive breast cancer with clinical evidence of metastatic disease
  • ✓At least one measurable lesion (>2 cm by imaging)
  • ✓ECOG performance status 0 or 1
  • ✓Life expectancy at least 12 weeks
Key exclusion· 6
  • ✕Bone metastases or other non-measurable disease as sole evidence of metastasis
  • ✕Evidence of active brain metastasis including leptomeningeal involvement
  • ✕Pre-existing peripheral neuropathy greater than grade 1
  • ✕Prior chemotherapy for metastatic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00110084
NCT00110084Phase 2Completed
CompareCT.gov

Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer

Mayo Clinic·interventional·Posted May 4, 2005·Updated Jun 2, 2011

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Paclitaxel protein-bound particles for injectable suspension (albumin-bound) for Breast Cancer. Completed, enrolled 50 participants across 201 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2005
Enrollment StartAug 1, 2005
Primary CompletionMay 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 21.2 years ago

Interventions

Gemcitabinedrug

1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Paclitaxel protein-bound particles for injectable suspension (albumin-bound)drug

125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle