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RecruitingInterventionalPhase 2

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

NCT ID: NCT02476786Sponsor: Washington University School of MedicineLast updated: 2025-07-28

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.

Arms & 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

Outcome measures

Primary

  • Response rate

    * Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. * In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores \<18 indicating low risk.

    Time frame: 6 months

Secondary

  • Breast cancer-specific survival

    Time frame: 6 months

  • Breast cancer-specific survival

    Time frame: 1 year

  • Breast cancer-specific survival

    Time frame: 2 years

  • Rate of overall survival

    Time frame: 5 years

Eligibility criteria

Sex: FemaleAge: 70 Years and olderHealthy 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 locations (1)

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Rebecca L Aft, M.D., Ph.D. · Contact
Tracey Guthrie · Contact
Rebecca L Aft, M.D., Ph.D. · Principal Investigator
Foluso Ademuyiwa, M.D. · Sub Investigator
Ron Bose, M.D., Ph.D. · Sub Investigator
Andrew Davis, M.D. · Sub Investigator
William Gillanders, M.D. · Sub Investigator
Cynthia X Ma, M.D., Ph.D. · Sub Investigator
Julie Margenthaler, M.D. · Sub Investigator
Rama Suresh, M.D. · Sub Investigator
Katherine N Weilbaecher, M.D. · Sub Investigator
Ashley Frith, M.D. · Sub Investigator
Peter Oppelt, M.D. · Sub Investigator
Antonella Rastelli, M.D. · Sub Investigator
Caron Rigden, M.D. · Sub Investigator
Lindsay Peterson, M.D. · Sub Investigator
Fei Wan, Ph.D. · Sub Investigator
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score | Cancerify