Tamoxifen Citrate or Aromatase Inhibitor in Treating Elderly Patients with Estrogen Receptor Positive Breast Cancer That Can Be Removed by Surgery

Status: Active

Description

This phase II trial studies how well tamoxifen citrate or aromatase inhibitor works in treating elderly patients with estrogen receptor positive breast cancer that can be removed by surgery. Hormone therapy using tamoxifen citrate or aromatase inhibitor may fight estrogen receptor positive breast cancer by lowering the amount of estrogen the body makes and by blocking the use of estrogen by the tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0
  • Disease must be ER+ and HER2-
  • Ki67 score/proliferative index =< 30% or low to intermediate mitotic index
  • Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 3
  • Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable)

Exclusion Criteria

  • Prior surgery for this cancer
  • A history of other malignancy =< 5 years previous which would preclude endocrine treatment of their cancer
  • Currently receiving any other investigational agents
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study
  • Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements
  • Known human immunodeficiency virus (HIV)-positivity on combination antiretroviral therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

Locations & Contacts

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Contact: Rebecca L. Aft
Phone: 314-747-0063
Email: aftr@wudosis.wustl.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To correlate response to neoadjuvant endocrine treatment at 6 months with Oncotype DX Recurrence Score in women with early-stage estrogen receptor (ER)+ breast cancer who are 70 or older.

SECONDARY OBJECTIVES:

I. To determine the breast cancer-specific survival of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

II. To determine the rate of overall survival of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

EXPLORATORY OBJECTIVES:

I. To evaluate the molecular characteristics of breast cancers of women with early-stage ER+ breast cancer who are 70 or older who do respond to primary endocrine therapy versus those who do not.

II. To determine compliance with medications of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

III. To evaluate cost-effectiveness of treating women with early-stage ER+ breast cancer who are 70 or older with endocrine therapy alone.

IV. To track the ER score (by reverse transcription [RT]-polymerase chain reaction [PCR], within the Recurrence Score) and response of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

V. To track the quality of life (by Functional Assessment of Cancer Therapy-Breast [FACT-B]) of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

OUTLINE:

Patients receive tamoxifen citrate or aromatase inhibitors as directed by the package insert at the discretion of the treating physician for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients who progress receive recommended standard care.

After completion of study treatment, patients are followed up every year for 5 years and at 10 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Siteman Cancer Center at Washington University

Principal Investigator
Rebecca L. Aft

Trial IDs

Primary ID 201611010
Secondary IDs NCI-2016-01714
Clinicaltrials.gov ID NCT02476786