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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001378
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: November 1999
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Breast Neoplasms
Drug: fenretinide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Pilot Trial of Tamoxifen and 4-HPR (4-N-Hydroxyphenyl Retinamide) in Persons at High Risk for Developing Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 75
Study Start Date: January 1994
Estimated Study Completion Date: November 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00001378

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001378     History of Changes
Other Study ID Numbers: 940056, 94-C-0056
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
4-Quadrant Fine Needle Aspiration
Biomarkers
Chemoprevention
Nipple Suction Aspirates
TGF Beta

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014