Recruiting
Phase 2

Endocrine Treatment

Sponsor:

Washington University School of Medicine

Code:

NCT02476786

Conditions

Breast Cancer

Cancer of Breast

Breast Neoplasms

Cancer of the Breast

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Not accepted

Interventions

FACT-B

Goserelin

Anastrozole

Exemestane

Fulvestrant

Study Details

Brief summary:

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

Breast Cancer

Cancer of Breast

Breast Neoplasms

Cancer of the Breast

Study ID

NCT02476786

Start date

Jan 17, 2017

Status verified date

Jul, 2026

Completion date

Jul 31, 2032

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

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).

Goserelin

Anastrozole

Exemestane

Fulvestrant

Tamoxifen

Archived tissue collection

Primary outcome measure

  • Response rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Rebecca L Aft, M.D., Ph.D.

314-747-0063aftr@wustl.edu

Tracie Guthrie

314-747-4404guthriet@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Rebecca L Aft, M.D., Ph.D.

314-747-0063aftr@wustl.edu

Tracey Guthrie

314-747-4404guthriet@wustl.edu

Principal Investigator:

Rebecca L Aft, M.D., Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-27.