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

Stopped early · Phase 1

Conditions studied: Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

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.

Key facts

Study ID

NCT01149356

Run by

National Cancer Institute (NCI)

People needed

15

Starts

2010-10-01

Expected to finish

2013-04-01

Last updated by the study team

2015-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 2 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Able to swallow and retain oral medication
• Negative pregnancy test
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for ≥ 12 months after completion of study therapy

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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