Fulvestrant or Tamoxifen Citrate in Treating Patients with Cyclin D1 and Estrogen Receptor Positive Breast Cancer
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- New diagnosis of invasive cyclin D1 +, estrogen receptor (ER)+, progesterone receptor (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 (immunohistochemistry [IHC] score 0-1 or fluorescence in situ hybridization [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
- Postmenopausal women * Postmenopausal if satisfies one or more of the following criteria: age greater than 52 years of age; having had a bilateral oophorectomy; amenorrhoeic for at least 12 months
- 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
I. To answer the research question: "Does treatment with fulvestrant result in a significant change in proliferation index compared to tamoxifen citrate (tamoxifen) in premenopausal patients with cyclin D1 +, estrogen receptor + breast cancer?" via a small scale preoperative window trial randomizing these women to 3 weeks of therapy with either tamoxifen or fulvestrant.
I. Determine the change in estrogen receptor and progesterone receptor levels between core biopsy and definitive surgery in patients treated with fulvestrant or tamoxifen.
II. Determine whether tamoxifen-resistance and fulvestrant-sensitivity gene expression signatures are observed in patients with cyclinD1 overexpressing breast cancers.
III. Determine whether patient’s response to tamoxifen or fulvestrant correlates with the response of their primary cells in vitro.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive tamoxifen citrate orally (PO) daily on days 1-21.
ARM B: Patients receive fulvestrant intramuscularly (IM) over 1-2 minutes on day 1.
After completion of study treatment, patients are followed up periodically.
Trial Phase Phase II
Trial Type Treatment
Icahn School of Medicine at Mount Sinai
Amy Diane Tiersten
- Primary ID 16-1470
- Secondary IDs NCI-2017-00945
- Clinicaltrials.gov ID NCT02936206