NCT00101062

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_2 breast-cancer

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

January 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

January 7, 2005

Last Update Submit

June 3, 2011

Conditions

Breast Cancer

Keywords

stage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancer

Interventions

celecoxibDRUG
letrozoleDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the breast * Locally advanced or metastatic disease * Measurable disease * No bone disease only * No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry * Hormone receptor status: * Estrogen receptor- OR progesterone receptor-positive PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Postmenopausal, as defined by 1 of the following: * Prior bilateral oophorectomy * Prior bilateral ovarian irradiation * No spontaneous menstrual bleeding within the past 12 months * Age 55 and over AND prior hysterectomy without oophorectomy * Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Granulocyte count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs * No prior allergic reaction to sulfonamides * No active peptic ulcer disease * No active infection * No other medical condition that would preclude study participation * Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for metastatic or recurrent disease Endocrine therapy * No prior endocrine therapy for metastatic disease * Prior adjuvant tamoxifen allowed * No prior aromatase inhibitors * No prior hormonal therapy for recurrent disease * No other concurrent hormonal therapy Radiotherapy * See Disease Characteristics * See Menopausal status * No concurrent radiotherapy Surgery * See Disease Characteristics * See Menopausal status Other * No concurrent fluconazole or lithium * No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors * Concurrent chronic cardioprotective low-dose aspirin allowed * No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CelecoxibLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNitrilesTriazoles

Study Officials

  • Antoinette R. Tan, MD

    Rutgers Cancer Institute of New Jersey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2005

First Posted

January 10, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(1)