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Purpose

Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.

Conditions

Eligibility

Eligible Ages
Over 70 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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. - 70 years of age or older. - ECOG performance status ≤ 3 - Able to understand and willing to sign an 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 HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Endocrine therapy alone 		- Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen - Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment - After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy - Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire - Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)
  • Behavioral: FACT-B
    The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).
  • Drug: Goserelin
    Other names:
    • Goserelin acetate
    • Zoladex
  • Drug: Anastrozole
    Other names:
    • Arimidex®
  • Drug: Exemestane
    Other names:
    • Aromasin®
  • Drug: Fulvestrant
    Other names:
    • Faslodex®
  • Drug: Tamoxifen
    Other names:
    • Nolvadex®
  • Other: Archived tissue collection

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St. Louis, Missouri 63110
Contact:
Rebecca L Aft, M.D., Ph.D.
314-747-0063
aftr@wustl.edu

More Details

NCT ID
NCT02476786
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Rebecca L Aft, M.D., Ph.D.
314-747-0063
aftr@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.