NCT00253500

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are undergoing surgery for stage I, stage II, or stage III breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

November 11, 2005

Last Update Submit

July 22, 2020

Conditions

Breast Cancer

Keywords

stage II breast cancerstage I breast cancerstage IIIA breast cancerstage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

  • Complete pathological response rate by tumor analysis after surgery

    No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.

    4 weeks

Secondary Outcomes (4)

  • Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks

    4 weeks

  • Toxicity by physical exam and medical history every 14 days prior to surgery

    2-4 weeks

  • Predictive value of HER2 gene amplification and topoisomerase II-alpha gene amplification or deletions for pathologic complete response, clinical complete response or disease progression after surgery

    5 years

  • Gene expression after surgery

    5 years

Study Arms (1)

Epirubicin

EXPERIMENTAL
Biological: pegfilgrastimDrug: epirubicin hydrochlorideProcedure: conventional surgery

Interventions

pegfilgrastimBIOLOGICAL

6 mg in a syringe

Also known as: Neulasta
Epirubicin
epirubicin hydrochlorideDRUG

120 MG q 2 weeks for 4 cycles

Epirubicin
conventional surgeryPROCEDURE

to remove small piece of cancer

Also known as: Biopsy will involve a small surgical incision to remove a piece of the cancer.
Epirubicin

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Stage I, II, or III disease (T1, T2, or T4; N0-2; M0) * Resectable disease * Unidimensionally measurable disease * Primary tumor ≥ 2 cm * No known distant metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,500/mm\^3 * Hemoglobin ≥ 8 g/dL * Platelet count ≥ 100,000/mm\^3 * No known untreated bleeding diathesis Hepatic * AST ≤ 2 times upper limits of normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * LVEF ≥ 50% on echocardiogram, MUGA, or cardiac catheterization Other * Not pregnant or breastfeeding * Fertile patients must use effective contraception * Negative pregnancy test * No concurrent illness that would preclude study treatment * No known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim (G-CSF), or any other component of these products PRIOR CONCURRENT THERAPY: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastimEpirubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • George T. Budd, MD

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

June 1, 2002

Primary Completion

September 1, 2005

Study Completion

December 1, 2010

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

US(1)