RecruitingPhase 2NCT02476786

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

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


Sponsor

Washington University School of Medicine

Enrollment

50 participants

Start Date

Jan 17, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether older women with early-stage, slow-growing breast cancer can be safely and effectively treated with hormone-blocking pills alone (such as an aromatase inhibitor), without undergoing surgery — particularly for patients whose tumors are estrogen-driven and show low signs of aggressive growth. **You may be eligible if...** - You are 70 years of age or older - You have newly diagnosed early-stage breast cancer that could potentially be removed with surgery (not yet spread to distant organs) - Your cancer is estrogen receptor positive (ER+) and HER2 negative - Your tumor grows slowly (low Ki67 score or low to intermediate growth index) - Your tumor can be measured by ultrasound or mammogram - You are in reasonably good health overall **You may NOT be eligible if...** - You have already had surgery for this cancer - You had another cancer within the past 5 years - You are currently enrolled in another experimental treatment study - You have uncontrolled illness that would prevent safe participation - You have HIV and are on combination antiretroviral therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFACT-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).

DRUGGoserelin
DRUGAnastrozole
DRUGExemestane
DRUGFulvestrant
DRUGTamoxifen
OTHERArchived tissue collection

Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT02476786


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