NCT00886535

Brief Summary

This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2017

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

3.8 years

First QC Date

April 22, 2009

Last Update Submit

March 12, 2019

Conditions

Breast CancerDuctal Carcinoma in Situ

Keywords

breast cancerhot flashestamoxifen

Outcome Measures

Primary Outcomes (1)

  • Hot flashes

    2 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Females, age 18 years of age and above. Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ or as chemoprevention.

You may qualify if:

  • Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ, or as chemoprevention
  • Age 18 years and above
  • May be pre- and post-menopausal
  • Females
  • Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy
  • Must use a reliable form of birth control

You may not qualify if:

  • Pregnant
  • Breastfeeding
  • Concurrent use of corticosteroids, megestrol, or phenobarbital
  • History of allergy to tamoxifen
  • Unwilling to have a yearly gynecological exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingHot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullarySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leah Cream, MD

    Penn State Hershey Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

February 1, 2010

Primary Completion

December 1, 2013

Study Completion

July 27, 2017

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

US(1)