Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

August 3, 2023 updated by: NCIC Clinical Trials Group

A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Atlantic Health Sciences Corporation
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Univ. Health Network-Princess Margaret Hospital
    • Quebec
      • Quebec City, Quebec, Canada, G1S 4L8
        • CHA-Hopital Du St-Sacrement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria:

    • T4, NX, M0
    • Any T, N2-N3, M0
    • Inflammatory breast cancer (redness over at least one-third of the breast), M0
  • No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan
  • Diagnosed within the past 8 weeks
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin less than upper limit of normal (ULN)
  • Must meet criteria for 1 of the following:

    • ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN
    • ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • Resting LVEF normal by MUGA or echocardiogram
  • No congestive heart failure
  • No angina pectoris
  • No myocardial infarction within the past year
  • No uncontrolled hypertension
  • No uncontrolled arrhythmias

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
  • No symptomatic peripheral neuropathy grade 2 or greater
  • No active infection
  • No history of significant neurological or psychiatric disorders, including dementia or seizures
  • No peptic ulcer
  • No unstable diabetes mellitus
  • No contraindication to dexamethasone
  • No known sensitivity to E. coli-derived or polyethylene glycol products
  • Willing to undergo core biopsies once prior to registration and core biopsies at 2 other timepoints while on study
  • Geographically accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy for breast cancer

Chemotherapy

  • No prior chemotherapy for breast cancer

Endocrine therapy

  • No prior hormonal therapy for breast cancer
  • No concurrent corticosteroids except for premedication or hypersensitivity reaction
  • No concurrent oral contraception

Radiotherapy

  • No prior radiotherapy for breast cancer

Surgery

  • No prior surgery for breast cancer other than biopsy

Other

  • No prior systemic therapy for breast cancer
  • No other concurrent investigational drugs or anticancer treatment
  • No concurrent preventative IV antibiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegfilgrastim, docetaxel and epirubicin
Dose escalation schedule A&B = 6mg fixed dose once per cycle on day 2
Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2
Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxic effects
Time Frame: 7 years
Findings were presented at ASCO 2010
7 years
Response (phase II)
Time Frame: 12 years
Response was presented at ASCO 2010. Duration of response will be analyzed in 2015
12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Maureen E. Trudeau, BSc, MA, MD, FRCPC, Toronto Sunnybrook Regional Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2003

Primary Completion (Actual)

January 6, 2010

Study Completion (Actual)

January 16, 2014

Study Registration Dates

First Submitted

August 6, 2003

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimated)

August 7, 2003

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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