NCT00193206

Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

Phase II Trial of Dose Dense Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

Detailed description

Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen: Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles
DRUG	Epirubicin	Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles
DRUG	Albumin-bound Paclitaxel	ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-10-01
• Completion: 2009-05-01
• First posted: 2005-09-19
• Last updated: 2021-11-23
• Results posted: 2012-11-30

Locations

13 sites across 1 country: United States