A Pilot Trial of Tamoxifen and 4-HPR (4-N-Hydroxyphenyl Retinamide) in Persons at High Risk for Developing Breast Cancer

March 3, 2008 updated by: National Cancer Institute (NCI)

This is a pilot, chemoprevention study. Patients receive fenretinide daily for 25 of every 28 days for 4 months and tamoxifen daily for 23 months, beginning the second month of fenretinide.

Patients are removed from study for unacceptable toxicity, the development of invasive breast cancer, or for dysfunctional uterine bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot chemo-prevention study of the combination tamoxifen and 4-HPR in persons at increased risk of developing invasive breast cancer. The objectives of the study are to determine the acute and cumulative toxicity of tamoxifen and 4-HPR in high risk persons; to assess the feasibility of obtaining adequate tissue to study potential intermediate biomarkers of proliferative disease and malignancy using nipple aspiration, four quadrant fine needle aspirates, and breast core needle biopsies; and to study the effects of tamoxifen and 4-HPR on TGF-beta isoforms and the proliferative markers ki67 and PCNA pre- and post-therapy.

Study Type

Interventional

Enrollment

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

POPULATION CHARACTERISTICS:

Women and men at increased risk for the development of breast cancer by at least one of the following criteria:

Histologically documented ductal carcinoma in situ (DCIS), including DCIS with minimal invasion or microinvasion.

Histologically documented lobular neoplasia, including lobular hyperplasia and lobular carcinoma in situ (LCIS).

Histologically documented atypical ductal hyperplasia in postmenopausal women.

Histologically documented atypical ductal hyperplasia in premenopausal women with 1 first-degree relative (mother or sister) diagnosed with breast cancer.

Histologically documented atypical ductal hyperplasia in premenopausal women with 3 or more relatives diagnosed with breast cancer provided at least 1 is a second-degree relative.

3 or more first- or second-degree relatives diagnosed with breast or ovarian cancer with at least 1 diagnosed with breast cancer.

2 or more premenopausal (under age 50) first-degree relatives diagnosed with breast cancer.

1 or more first-degree relatives diagnosed with breast cancer if at least 1 relative in the extended pedigree had ovarian cancer.

3 or more relatives with breast cancer with at least 1 first-degree relative diagnosed with premenopausal breast cancer.

Previously diagnosed Stage I breast cancer with surgery and/or radiotherapy only (without prior adjuvant chemo- or hormonal therapy).

Positive for the BRCA1/BRCA2 gene.

No history of other invasive breast cancer.

No evidence of malignancy on breast and gynecologic exams.

Participants with a family history of breast cancer will be seen in consultation by the Family Studies Branch, NCI.

PRIOR/CONCURRENT THERAPY:

Mastectomy or lumpectomy plus radiotherapy required prior to entry for patients with DCIS. Patients with DCIS who have participated in protocol NCI-MB-348 eligible.

No participation in any other breast cancer prevention study involving pharmacologic intervention.

No prior chemotherapy or hormonal therapy for invasive breast cancer.

At least 3 months since estrogen or progesterone replacement therapy or hormonal contraceptives.

PATIENT CHARACTERISTICS:

Age: 35 and over.

Performance status: Ambulatory.

Life expectancy: At least 10 years.

Hematopoietic: Complete blood count normal.

Hepatic:

Bilirubin normal.

Alkaline phosphate normal.

AST normal.

PT, PTT normal.

No history of bleeding disorder.

No history of chronic hepatitis or cirrhosis.

Renal:Creatinine less than 1.5 mg/dL.

Cardiovascular:

No history of deep venous thrombosis.

No history of pulmonary embolus.

Other:

No allergy to any study medication.

Capable of tolerating multiple diagnostic procedures.

No history of abnormal vaginal bleeding. Hysterectomy for vaginal bleeding of benign etiology allowed.

No history of retinal disease, macular degeneration, or night blindness.

No medical or psychiatric risk due to nonmalignant systemic disease that would preclude study participation.

No history of malignancy except: Curatively treated nonmelanomatous skin cancer. Curatively treated in situ cervical carcinoma. Hodgkin's disease treated more than 5 years ago.

No pregnant women.

Adequate contraception required of fertile patients during and for 12 months after fenretinide and for 2 months after tamoxifen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1994

Study Completion

November 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

November 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 940056
  • 94-C-0056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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