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Investigator(s):
Shivaani Kummar, M.D., F.A.C.P. Principal Investigator Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov	Jennifer Zlott, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-435-5664 Fax: 301-480-7281 zlottjh@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed diagnosis of one of the following solid tumors:
• ER+ or PR+ breast cancer, non-small cell lung cancer, colorectal cancer, or prostate
• Desmoid tumors or gynecologic cancer
• Patients with breast cancer must have had at least one prior chemotherapy regimen and one prior hormonal regimen for metastatic disease
• All other patients must have disease that has progressed following at least one line of standard therapy
• Absolute neutrophil count ≥ 1,500/microL
• Platelets ≥ 100,000/microL
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)
• No untreated spinal cord metastasis or metastasis close to vital organs because of risk of hormonal flare
• No clinically significant intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements

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Study Outline:

• Screening with a physical examination and medical history; imaging studies; and blood and urine samples
• Z-endoxifen will be administered orally once a day in 28-day cycles
• Cycles continue in the absence of disease progression or unacceptable toxicity
• Participants will have regular clinic visits with blood and urine samples and imaging studies

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 9/20/12