NCT00080626

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
terminated

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

August 11, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

April 7, 2004

Last Update Submit

March 19, 2019

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Correlation between change in apoptosis and proliferation with response after definitive surgery

    Definitive surgery

Secondary Outcomes (1)

  • Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery

    Definitive surgery

Study Arms (1)

Docetaxel

EXPERIMENTAL

Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.

Biological: pegfilgrastimDrug: docetaxelProcedure: conventional surgeryProcedure: neoadjuvant therapy

Interventions

pegfilgrastimBIOLOGICAL

6 mg injection on day 1 of each cycle

Also known as: Neulasta
Docetaxel
docetaxelDRUG

100 mg per meter-squared, every 14 days for 4 cycles

Also known as: Taxotere
Docetaxel
conventional surgeryPROCEDURE

lumpectomy or mastectomy at end of treatment

Also known as: definitive surgery
Docetaxel
neoadjuvant therapyPROCEDURE

treatment prior to definitive breast surgery

Docetaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed infiltrating carcinoma of the breast * Unresected clinical stage T1c, T2, T3, or T4 lesion, any N * Newly diagnosed disease * Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry * Mammogram of the contralateral breast within 6 months before study entry * Clinically measurable disease * Hormone receptor status: * Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic * Bilirubin no greater than 1.5 times normal Renal * Creatinine no greater than 1.5 times normal Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for current breast cancer Endocrine therapy * At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention * No prior endocrine therapy for current breast cancer Radiotherapy * No prior radiotherapy for current breast cancer Surgery * 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)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastimDocetaxelNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCombined Modality TherapyTherapeutics

Study Officials

  • Vered Stearns, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

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

April 7, 2004

First Posted

April 8, 2004

Study Start

August 11, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

US(1)