RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer

NCT01149356 | Terminated Phase 1

• 6 other identifiers: NCI-2010-02181MCC-8539CDR00006756128539N01CM00100P30CA076292
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

This partially randomized phase I trial is studying the side effects and the best dose of RO4929097 when given together with exemestane and to see how well it works compared to exemestane alone in treating premenopausal and postmenopausal patients with advanced or metastatic breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving exemestane together with RO4929097 may kill more breast cancer cells.

Conditions

Estrogen Receptor Positive; HER2/Neu Negative; Male Breast Carcinoma; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent adverse events (TEAEs) based on CTCAE version 3 grade

  Will be summarized by body system, preferred term, verbatim of adverse event, intensity, and relationship to each study drug (BMS-936558 and/or the peptide vaccine).

  Up to 70 days

• Time to relapse

  Time to relapse will be summarized using descriptive statistics.

  Up to 2 years

Secondary Outcomes (1)

• Overall survival

  Up to 2 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral exemestane once daily on days 1-21 and oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Exemestane; Drug: Gamma-Secretase Inhibitor RO4929097; Drug: Goserelin Acetate

Arm II

ACTIVE COMPARATOR

Patients receive exemestane as in arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Exemestane; Drug: Goserelin Acetate

Interventions

Exemestane DRUG

Given orally

Also known as: Aromasin, FCE-24304

Arm I; Arm II

Gamma-Secretase Inhibitor RO4929097 DRUG

Given orally

Also known as: RO4929097

Arm I

Goserelin Acetate DRUG

Given subcutaneously to premenopausal patients

Also known as: ZDX, Zoladex

Arm I; Arm II

Eligibility Criteria

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

You may qualify if:

• Diagnosis of breast cancer
• Locally advanced or metastatic disease for which curative measures are not effective
• Relapsed disease with (or within 6 months of discontinuation of) an adjuvant nonsteroidal aromatase inhibitor or tamoxifen
• Progressive disease during treatment with first- or second-line hormonal therapy that could include a nonsteroidal aromatase inhibitor, tamoxifen, or fulvestrant
• Recurrent disease
• No locally recurrent resectable disease
• Histologically confirmed estrogen receptor-positive (ER+) by IHC
• Must have ≥ 5% strong staining for ER+ or ≥ 10% weak staining
• Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan
• No HER2/neu-positive disease
• No known brain metastases
• Pre- or postmenopausal status
• ECOG performance status 0-1
• Life expectancy ≥ 6 months
• WBC ≥ 3,500/mm\^3

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

exemestane; 2,2-dimethyl-N-(6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-N'-(2,2,3,3,3-pentafluoropropyl)malonamide; Goserelin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Julie Means-Powell, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

US (4)