Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age70 Years to no maximum
• SexFemale
• Healthy volunteersNo

You may be able to join if

• 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).

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

tamoxifen citrate. The citrate salt of an antineoplastic nonsteroidal selective estrogen receptor modulator (SERM). Tamoxifen competitively inhibits the binding of estradiol to estrogen receptors, thereby preventing the receptor from binding to the estrogen-response element on DNA. The result is a reduction in DNA synthesis and cellular response to estrogen. In addition, tamoxifen up-regulates the production of transforming growth factor B (TGFb), a factor that inhibits tumor cell growth, and down-regulates insulin-like growth factor 1 (IGF-1), a factor that stimulates breast cancer cell growth. Tamoxifen also down-regulates protein kinase C (PKC) expression in a dose-dependant manner, inhibiting signal transduction and producing an antiproliferative effect in tumors such as malignant glioma and other cancers that overexpress PKC. NCI Drug Dictionary

letrozole. A nonsteroidal inhibitor of estrogen synthesis with antineoplastic activity. As a third-generation aromatase inhibitor, letrozole selectively and reversibly inhibits aromatase, which may result in growth inhibition of estrogen-dependent breast cancer cells. Aromatase, a cytochrome P-450 enzyme localized to the endoplasmic reticulum of the cell and found in many tissues including those of the premenopausal ovary, liver, and breast, catalyzes the aromatization of androstenedione and testosterone into estrone and estradiol, the final step in estrogen biosynthesis. NCI Drug Dictionary

Treatments listed in the registry

• FACT-B (Behavioral): 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 (Drug)
• Anastrozole (Drug)
• Exemestane (Drug)
• Fulvestrant (Drug)
• Tamoxifen (Drug)
• Archived tissue collection (Other)

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• questionnaires: Part of the study plan

Main goals

• Response rate (6 months)

Other goals

• Breast cancer-specific survival
• Breast cancer-specific survival
• Breast cancer-specific survival
• Rate of overall survival

Planned enrollment: 50 (estimated).

• Washington University School of Medicine, St Louis, Missouri

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT02476786
• NCI Drug Dictionary: C855
• NCI Drug Dictionary: C1527

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 26, 2026. Public record; not medical advice.