Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.

Stopped early · Phase 1

Conditions studied: Breast Cancer

In brief

The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal and post-menopausal women before and after exposure to one of the two commonly used breast cancer drugs, tamoxifen or fulvestrant.

Key facts

Study ID

NCT02936206

Run by

Icahn School of Medicine at Mount Sinai

People needed

2

Starts

2016-10-01

Expected to finish

2020-05-01

Last updated by the study team

2021-05-19

Who can join

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

You may qualify if…

• Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the study treatment regimen and follow-up, must be obtained and documented according to the local regulatory requirements
• Adult women greater than 18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• New diagnosis of invasive cyclin D1 +, ER+, PR +/-, Her2- breast cancer
• Cyclin D1 positive as defined as a total immunohistochemical score of 5 or greater
• Hormone receptor positive as defined as ≥ 10% positive stained cells
• HER2-normal (IHC score 0-1 or FISH negative [in-situ hybridization (ISH) ratio <= 2.0 status])
• Tumor size at least 5 mm with planned primary surgery at Mount Sinai
• A negative urine dipstick pregnancy test

You may not qualify if…

• Estrogen receptor negative invasive breast carcinoma as defined as less than 10% stained cells
• Prior antiestrogen therapy
• Tumor size less than 5 mm
• Prior diagnosis of thrombosis or known hypercoagulable state
• Known history of bleeding diathesis
• Known liver disease
• Prior treatment with neoadjuvant therapy
• Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
• Current severe or uncontrolled systemic disease
• Pregnancy or lactation period. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices) during study treatment.
• Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.

Where it is running

• Mount Sinai West — New York, New York, United States
• Mount Sinai St. Luke's — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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