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

• Status: Terminated
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: AstraZeneca
• Treatments: Estradiol; Fulvestrant; Tamoxifen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.