Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00066443
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose and recommended phase II dose of docetaxel and epirubicin when given with pegfilgrastim in women with locally advanced or inflammatory breast cancer. (Phase I, group 1 closed to accrual as of 9/13/04 and Phase II, group 1 closed to accrual as of 5/10/06)
* Determine the toxicity of this regimen in these patients.
* Determine the clinical and pathological response rate and duration of response in patients treated with this regimen.
* Determine drug sensitivity and resistance in patients treated with this regimen.
* Determine prognostic and predictive markers in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of docetaxel and epirubicin.
* Phase I:
Group 1 (21-day regimen) (closed to accrual as of 09/13/04): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 6 courses may receive additional therapy at the discretion of the physician.
Group 2 (14-day regimen): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 8 courses may receive additional therapy at the discretion of the physician.
Cohorts of 3-6 patients receive escalating doses of epirubicin and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
* Phase II:
Group 1 (21-day regimen) (closed to accrual as of 5/10/06): Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose.
Group 2 (14-day regimen): Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose.
Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 90 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 93
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pegfilgrastim, docetaxel and epirubicin epirubicin hydrochloride - Pegfilgrastim, docetaxel and epirubicin pegfilgrastim - Pegfilgrastim, docetaxel and epirubicin docetaxel -
- Primary Outcome Measures
Name Time Method Response (phase II) 12 years Response was presented at ASCO 2010. Duration of response will be analyzed in 2015
Toxic effects 7 years Findings were presented at ASCO 2010
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
CHA-Hopital Du St-Sacrement
🇨🇦Quebec City, Quebec, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada