--- title: Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer nct_id: NCT00066443 overall_status: COMPLETED phase: PHASE1, PHASE2 sponsor: NCIC Clinical Trials Group study_type: INTERVENTIONAL primary_condition: Breast Cancer countries: Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00066443.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00066443" ct_last_update_post_date: 2026-03-27 last_seen_at: "2026-05-12T07:34:23.113Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer **Official Title:** A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer **NCT ID:** [NCT00066443](https://clinicaltrials.gov/study/NCT00066443) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE1, PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 93 - **Lead Sponsor:** NCIC Clinical Trials Group - **Conditions:** Breast Cancer - **Start Date:** 2003-11-03 - **Completion Date:** 2014-01-16 - **CT.gov Last Update:** 2026-03-27 ## 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. ## Eligibility - **Minimum age:** 16 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Pegfilgrastim, docetaxel and epirubicin** (EXPERIMENTAL) ## Interventions - **pegfilgrastim** (BIOLOGICAL) — Dose escalation schedule A\&B = 6mg fixed dose once per cycle on day 2 - **docetaxel** (DRUG) — Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2 - **epirubicin hydrochloride** (DRUG) — Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV ## Primary Outcomes - **Toxic effects** _(time frame: 7 years)_ — Findings were presented at ASCO 2010 - **Response (phase II)** _(time frame: 12 years)_ — Response was presented at ASCO 2010. Duration of response will be analyzed in 2015 ## Locations (5) - CancerCare Manitoba, Winnipeg, Manitoba, Canada - Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada - Odette Cancer Centre, Toronto, Ontario, Canada - Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada - CHA-Hopital Du St-Sacrement, Québec, Quebec, Canada ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.cancercare manitoba|winnipeg|manitoba|canada` — added _(2026-05-12)_ - `locations.atlantic health sciences corporation|saint john|new brunswick|canada` — added _(2026-05-12)_ - `locations.odette cancer centre|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.univ. health network-princess margaret hospital|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.cha-hopital du st-sacrement|québec|quebec|canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00066443.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00066443* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*