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

NCT02936206 | Terminated Phase 1 Results DMC

• 1 other identifier: GCO 16-1470
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Keywords

proliferation Index; Tamoxifen; Fulvestrant; cyclinD1; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Change in Ki67 Cell Percentage

  The change in proliferation index as measured by the percentage of cells staining for Ki67 at 2 weeks as compared on baseline.

  baseline and 2 weeks

Secondary Outcomes (6)

• Change in Estrogen Receptor Level

  baseline and 2 weeks

• Change in Progesterone Receptor Level

  baseline and 2 weeks

• Incidence of Tamoxifen-resistance Gene Expression

  2 weeks

• Incidence of Fulvestrant-sensitivity Gene Expression

  2 weeks

• Drug Dose Level

  2 weeks

Study Arms (2)

Fulvestrant

EXPERIMENTAL

750 mg injection in 3 divided doses

Drug: Fulvestrant

Tamoxifen

ACTIVE COMPARATOR

20mg orally

Drug: Tamoxifen

Interventions

Fulvestrant DRUG

fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only

Also known as: Faslodex

Fulvestrant

Tamoxifen DRUG

14 days of treatment with tamoxifen 20mg orally each day

Also known as: Nolvadex

Tamoxifen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• AstraZeneca: collaborator

Study Sites (3)

Mount Sinai West

New York, New York, 10019, United States

Location

Mount Sinai St. Luke's

New York, New York, 10025, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Amy Tiersten
• Organization: Icahn School of Medicine at Mount Sinai

amy.tiersten@mssm.edu

212-241-3300

Study Officials

• Amy Tiersten, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)