Preoperative Testing of the Anti-Progesterone Mifepristone in Early Stage Breast Cancer

NCT01138553 | Terminated Early Phase 1 DMC

• 1 other identifier: UCSD#100231
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to identify the group of women with early stage breast cancer most likely to benefit from treatment with the selective progesterone receptor modulator (SPRM) mifepristone. This will be done by treating women briefly prior to planned surgery and examining the decrease in growth rate (measured by Ki-67 immunohistochemistry) in tumor samples taken before and after exposure to mifepristone.

Conditions

Invasive Breast Cancer; Ductal Carcinoma in Situ

Keywords

biomarker; breast cancer; antiprogesterone

Outcome Measures

Primary Outcomes (1)

• Change in proliferation by Ki-67 immunohistochemistry.

  5-30 days

Secondary Outcomes (2)

• Tumor size

  5-30 days

• Expression of related targets following mifepristone exposure

  5-28 days

Study Arms (1)

Mifepristone

EXPERIMENTAL

Drug: Mifepristone

Interventions

Mifepristone DRUG

200mg capsules daily for 5-28 days

Mifepristone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female identified as a candidate for primary resection of breast cancer (invasive or ductal carcinoma in situ) by a UCSD Breast Care Unit surgical oncologist
• Subjects must agree to contact the study coordinator prior to starting any new medications, vitamins or herbals during, or for 2 weeks following, mifepristone use
• Subjects must agree to abstain from alcohol use while on mifepristone
• Age ≥18
• ECOG performance status 0-1
• Prior to starting mifepristone subjects must have a negative urine (βHCG combo with on-board control) or blood pregnancy test and must be using one of the following acceptable means of birth control prior to starting study drug; Barrier methods or surgically sterile (tubal ligation, hysterectomy or partner with confirmed vasectomy). Alternatively the subject must be one year post-menopausal defined as greater than 12 months without a menstrual cycle
• Prior to starting mifepristone subjects must meet the following laboratory criteria; Granulocytes \> 1.5E9/l (grade ≤ 1); Platelets ≥ 100E9/l; Hemoglobin \> 10 g/dl (grade ≤ 1); Creatinine \< 1.5x normal reference range (grade ≤ 1); SGOT, SGPT, alk phos ≤ 1x normal reference range; Total bilirubin \< 1x normal reference range; Calcium \< 11.5 mg/dl (grade ≤ 1); HBsAg = Negative; HCV Ab = Negative; INR \< 1.5;
• Subjects must provide written informed consent

You may not qualify if:

• Not scheduled for surgery within 5 days of enrollment
• Subjects must not be on any therapy to treat breast cancer prior to surgical resection, specifically medications or recent (within 1 month of diagnostic biopsy) withdrawal of estrogen containing medication (eg. hormone replacement therapy)
• Subjects must not be on any medications, vitamins or herbals that are; potent inhibitors of cytochrome P450 CYP3A4, or sensitive substrates for cytochrome P450 CYP3A4
• Subjects may not have any history of significant cardiovascular, renal or hepatic disease requiring ongoing medical therapy or clinical intervention
• Subjects may not have a history of thrombophlebitis, thromboembolic disorder, or cerebral vascular disease.
• Subjects may not have any known hypersensitivity to mifepristone
• Subjects may not have a BMI \> 39
• Subjects may not have an IUD (Intrauterine contraceptive device), chronic adrenal failure, concurrent long term steroid therapy, history of allergy to mifepristone, hemorrhagic disorders or concurrent anticoagulant therapy, or inherited porphyrias

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, Rodabough RJ, Gilligan MA, Cyr MG, Thomson CA, Khandekar J, Petrovitch H, McTiernan A; WHI Investigators. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative Randomized Trial. JAMA. 2003 Jun 25;289(24):3243-53. doi: 10.1001/jama.289.24.3243.

  PMID: 12824205 BACKGROUND

Related Links

• UCSD Moores Cancer Center Clinical Trials

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Richard B Schwab, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Medicine

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2015
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

US (1)