Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer

NCT00853996 | Completed Phase 2 Results

• 5 other identifiers: NCI-2009-0111610588NCT00855751UW105-6-01N01CN35153
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well acolbifene works in preventing cancer in premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or coming back.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months

  Change in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.

  Baseline to 6 months

Secondary Outcomes (6)

• Change in Mammographic Breast Density

  Baseline to 6 months

• Change in Serum Estradiol Concentration

  Baseline to 6 months

• Change in Serum Concentration of Bioavailable Estradiol

  Baseline to 6 months

• Change in Serum Concentration of Testosterone

  Baseline to 6 months

• Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System

  Baseline to up to 2 weeks post-treatment

Study Arms (1)

Prevention (acolbifene hydrochloride)

EXPERIMENTAL

Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.

Drug: acolbifene hydrochloride

Interventions

acolbifene hydrochloride DRUG

Given orally

Also known as: EM-652.HCL, SCH 57068.HCl

Prevention (acolbifene hydrochloride)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gail risk \>= 1.7% and/or relative risk \>= 3 times that for 5-year age group
• Premenopausal
• More than 6 months since initiating or discontinuing oral contraceptives
• At increased risk for breast cancer, as indicated by \>= 1 of the following risk factors:
• BRCA1/2 mutation characterized as deleterious or of uncertain significance
• Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in situ
• Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia
• Family history consistent with hereditary breast cancer, as indicated by 1 of the following criteria:
• \>= 4 relatives with breast cancer
• \>= 2 relatives diagnosed with breast cancer at ≤ 50 years of age
• Breast and ovarian cancer diagnosed in same relative
• No suspicion for breast cancer on baseline mammogram performed between days 1-10 of menstrual cycle within 3 months prior to screening baseline RPFNA
• Exhibits hyperplasia with or without atypia (Masood score \>= 14) with \>= 500 cells AND Ki-67 positivity \>= 2% by RPFNA performed within 6 months prior to initiation of study drug
• Estimated visual mammographic breast density category \>= 5% on mammogram performed within 6 months prior to initiation of study drug
• Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic profile and blood count within normal limits

You may not qualify if:

• pregnant or nursing
• nursing within the past 6 months
• Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)
• History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes
• History of deep venous thrombosis
• History of allergic reactions attributed to compounds of similar chemical or biological composition to the study agent
• Other condition or concurrent illness that, in the opinion of the investigator, would make the patient a poor candidate for RPFNA
• Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen citrate, raloxifene, or arzoxifene hydrochloride)
• Other concurrent chemopreventive agents
• Concurrent anticoagulants
• Other concurrent investigational agents
• Bilateral breast implants

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bruce F. Kimler Ph.D
• Organization: University of Kansas Mecical Center

bkimler@kumc.edu

913-588-4523

Study Officials

• Carol Fabian

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 17, 2018
• Results First Posted: March 13, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)