NCT00295100

Brief Summary

The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial. Study participants will be randomly assigned to receive either tamoxifen or placebo for one year. Participants will subsequently be followed for one year off of medication. The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2000

Typical duration for phase_2 breast-cancer

Geographic Reach
2 countries

7 active sites

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

September 1, 2000

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 21, 2007

Status Verified

June 1, 2007

First QC Date

February 20, 2006

Last Update Submit

June 20, 2007

Conditions

Breast Cancer

Keywords

TamoxifenPreventionBreast CancerMRI

Outcome Measures

Primary Outcomes (1)

  • Breast Density

Secondary Outcomes (1)

  • Biomarkers

Interventions

TamoxifenDRUG

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Study participants will include healthy pre-menopausal women, ages 25 to 45 who meet all of the following eligibility criteria:
  • Signed and dated informed consent documents (2) for the study in accordance with all applicable Federal, State and Institutional regulations
  • Lifetime breast cancer risk \>20% based on the Gail model, the Claus model, a known familial breast cancer susceptibility mutation, a predicted probability of a BRCA1/2 mutation \> 25 % by the Couch model or diagnosis of LCIS or DCIS, or \> 20 Gy of external beam radiation delivered to the chest wall.
  • Regular monthly menstrual periods or pre-menopausal defined as cycle occurring every 21 - 35 days
  • Negative serum pregnancy test
  • Prior tubal ligation or willingness to use a non-hormonal barrier method of contraception for two (2) years
  • Prior to randomization, all baseline radiology test results (mammogram, MRI and biopsy, if applicable) must be reviewed to confirm absence of invasive cancer.

You may not qualify if:

  • Study participants will be excluded if any of the following conditions occur:
  • Absence of or irregular menstrual periods. Irregular menstrual period defined as menstrual cycle occurring \< 21 days or \> 35 days within the last six months or serum LH \> 45.
  • Oral contraceptive or other hormonal treatment within 3 months of study entry. The participant will be considered deferred for 3 months if she agrees to discontinue use of oral contraceptive pills or other hormonal treatment.
  • History or evidence of any malignancy
  • Use of the following concurrent medications: Anticoagulant therapy (e.g. coumarin containing agents and lovanox), estrogens (including Estring), progestins, androgens, or ovarian steroid hormones.
  • Concurrent serious medical illness including:
  • Uncontrolled Diabetes Mellitus (defined as HgA1C \> 9.0 %)
  • Uncontrolled hypertension (defined as systolic \>180 or diastolic \>110 on average of 2 or more readings taken at each of 2 or more visits after initial visit.)
  • Thromboembolic disease (DVT or PE)
  • Cerebrovascular disease (CVA or TIA)
  • Liver disease (AST and/or ALT \> 2 X normal)
  • Renal disease (BUN \> 30 mg/dl or Creatinine.\>2.0 mg/dl)
  • Pregnant or breast feeding
  • Breast implants
  • Prophylactic mastectomy
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

European Institute of Oncology

Milan, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Susan Domchek, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2006

First Posted

February 22, 2006

Study Start

September 1, 2000

Study Completion

July 1, 2006

Last Updated

June 21, 2007

Record last verified: 2007-06

Locations

IT(1)US(6)