NCT00088972|TerminatedPhase 2ResultsDMC

Study Stopped

Study closed due to poor accrual.

S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer

SWOG Cancer Research Network ClinicalTrials.gov

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4 other identifiers

CDR0000377698U10CA012027S0300U10CA037429

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2004

StartedNov 2004

CompletionJul 2009

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer. PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline

Completed

Started Nov 2004

Typical duration for phase_2 breast-cancer

Geographic Reach

1 country

9 active sites

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

4.7 years study duration

First Submitted

Initial submission to the registry

August 4, 2004

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed

3 months until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed

4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed

3.8 years until next milestone

Results Posted

Study results publicly available

April 9, 2013

Completed

Last Updated

August 10, 2018

Status Verified

July 1, 2018

Enrollment Period

4.7 years

First QC Date

August 4, 2004

Results QC Date

November 9, 2012

Last Update Submit

July 13, 2018

Conditions

Breast Cancer

Keywords

breast cancerbreast cancer in situlobular breast carcinoma in situductal breast carcinoma

Outcome Measures

Primary Outcomes (1)

Mammographic Density
The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.
1 year

Secondary Outcomes (1)

Ki-67 Expression
1 year

Study Arms (2)

Arm I - Celecoxib

EXPERIMENTAL

Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Drug: celecoxib

Arm II - Placebo

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.

Other: placebo

Interventions

celecoxibDRUG

Given orally

Arm I - Celecoxib

placeboOTHER

Given orally

Arm II - Placebo

Eligibility Criteria

Age18 Years - 120 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * At elevated risk of developing breast cancer, as defined by 1 of the following: * Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20% * Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ * Known deleterious mutation of BRCA1 or BRCA2 * At least 1 breast available for imagery and biopsy * Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry * Mammogram normal or benign (BIRADS score 0 or 1) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Premenopausal, defined by 1 of the following criteria: * Last menstrual period \< 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy * Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin \< 2.0 times institutional upper limit of normal (IULN) * SGOT or SGPT \< 2 times IULN * Alkaline phosphatase \< 2 times IULN * INR ≤ 1.5 * PT and PTT ≤ IULN Renal * Serum creatinine \< 2.0 times IULN Cardiovascular * No history of myocardial infarction * No angina pectoris * No known coronary artery disease * No history of stroke or mini-stroke (e.g., transient ischemic attack) * No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism) * No uncontrolled hypertension (i.e., blood pressure \> 140/90 mmHg) Pulmonary * No asthma after taking aspirin or other NSAIDs Other * No known sensitivity to celecoxib * No allergy to sulfonamides * No urticaria or allergic-type reactions after taking aspirin or other NSAIDs * No extreme lactose intolerance * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder) * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * More than 5 years since prior biologic therapy for cancer Chemotherapy * More than 5 years since prior chemotherapy for cancer Endocrine therapy * At least 28 days since prior tamoxifen * No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors * Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry Radiotherapy * No prior radiotherapy to the breast to be studied Surgery * Not specified Other * At least 7 days since prior anticoagulant therapy * More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration * Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month) * No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase

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

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (9)

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, 91204, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Baylor University Medical Center - Houston