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Trial record 3 of 1595 for:    Farber's Disease

Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
AstraZeneca
Information provided by (Responsible Party):
Judy E. Garber, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165308
First received: September 9, 2005
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.


Condition Intervention
Hodgkin's Disease
Breast Cancer
Drug: Tamoxifen

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Feasibility Study of Tamoxifen Prevention of Breast Cancer in Hodgkin's Disease Survivors

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the feasibility of a randomized trial testing the effectiveness of tamoxifen in reducing the risk of radiogenic breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and effect on quality of life in participating women. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: April 2001
Study Completion Date: June 2009
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamoxifen
Single arm: Tamoxifen 20mg daily
Drug: Tamoxifen
Given orally, daily for one year.

Detailed Description:
  • Patients will receive tamoxifen orally once daily to be taken at home for 1 year. They will be asked to complete a daily drug log to keep track of the pills taken or missed.
  • Patients will also be asked to give a blood/DNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future.
  • Patients will also receive a mammogram that will be reviewed by study officials.
  • Side effects will be monitored every 2 months for one year, between visits to the clinic.
  • A follow-up visit will be conducted at the 6 month mark and includes a physical exam, blood work, health and wellness surveys)
  • A follow-up visit will be performed at the 1 year mark and includes a mammogram, gynecological exam, physical exam, blood work, health and wellness surveys.
  • Patients active participation will be for 1 year. However, tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer, the patient may decide to stay on tamoxifen for 4 additional years.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females diagnosed with Hodgkin's Disease at age < 35 years
  • > 5 years from mantle or chest radiation
  • Current age > 30 years
  • Has completed childbearing
  • Willingness to discontinue use of oral contraceptives or other hormonal contraception for duration of the study

Exclusion Criteria:

  • History of secondary malignancy after Hodgkin's disease, except thyroid cancer of basal cell cancer
  • Recurrence of Hodgkin's disease in the 5 years before study entry
  • Current participation in any other cancer prevention study
  • Current or prior use of tamoxifen
  • Current use of coumadin
  • History of deep venous thrombosis, pulmonary embolism, or a condition known to be associated with hypercoagulability
  • History of cerebrovascular accident
  • History of macular degeneration
  • Current use of chemotherapy for benign disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165308

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
AstraZeneca
Investigators
Principal Investigator: Judy Garber, MD, MPH Dana-Farber Cancer Institute
Principal Investigator: Lisa Diller, MD Dana-Farber Cancer Institute
  More Information

No publications provided by Dana-Farber Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judy E. Garber, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165308     History of Changes
Other Study ID Numbers: 00-253
Study First Received: September 9, 2005
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Hodgkin's disease
breast cancer prevention
tamoxifen

Additional relevant MeSH terms:
Hodgkin Disease
Breast Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Skin Diseases
Breast Neoplasms
Lymphoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014