NCT00003099

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide and tamoxifen before surgery may be an effective way to prevent the recurrence of or further development of breast cancer. PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen given before surgery in treating women with breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started May 1996

Longer than P75 for phase_2 breast-cancer

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

Study Start

First participant enrolled

May 1, 1996

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

4.1 years

First QC Date

November 1, 1999

Last Update Submit

July 27, 2012

Conditions

Breast Cancer

Keywords

breast cancerTamoxifenFenretinideChemoprevention TherapyN-(4-hydroxyphenyl) Retinamide4-HPRBreast NeoplasiaDiagnostic Core BiopsySurgery

Outcome Measures

Primary Outcomes (1)

  • Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer

    28 days

Study Arms (2)

Arm 1 Tamoxifen + Fenretinide

ACTIVE COMPARATOR

Tamoxifen + Fenretinide daily for 14-28 days

Drug: FenretinideDrug: Tamoxifen Citrate

Arm 2 Placebo

PLACEBO COMPARATOR

Placebo daily for 14-28 days

Other: Placebo

Interventions

FenretinideDRUG

Daily for 14-28 days.

Also known as: 4-HPR, N-(4-hydroxyphenyl) Retinamide
Arm 1 Tamoxifen + Fenretinide
Tamoxifen CitrateDRUG

Daily for 14-28 days.

Also known as: Nolvadex
Arm 1 Tamoxifen + Fenretinide
PlaceboOTHER

Daily for 14-28 days

Arm 2 Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Mammogram highly suspicious for ductal carcinoma in situ or early invasive carcinoma Branching or linear microcalcifications clustered or distributed segmentally in the breast without an associated palpable or mammographic mass Palpable thickening or nipple discharge allowed At least 5 mm area of calcification or contain enough calcium for core biopsies Small palpable carcinoma (T1 or T2) with no palpable axillary lymph nodes (N0) No definitive local therapy Atypical hyperplasia (ductal or lobular) and/or carcinoma on initial diagnostic biopsy Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled congestive heart failure Other: Fasting serum triglycerides less than 400 mg/dL Fertile patients must use effective contraception during and for one year after completing fenretinide therapy No concurrent serious illness or infection, e.g., septicemia No prior thromboembolic disease No prior degenerative retinal disease PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: At least 12 months since prior tamoxifen therapy No concurrent estrogen therapy At least 3 months since prior anabolic steroids Radiotherapy: No prior radiotherapy to the chest or breast Surgery: See Disease Characteristics Other: No vitamin A supplementation greater than 25,000 IU At least 12 months since prior retinoid therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FenretinideTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, Aromatic

Study Officials

  • Sonja E. Singletary, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 16, 2004

Study Start

May 1, 1996

Primary Completion

June 1, 2000

Study Completion

January 1, 2003

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)