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

NCT02476786

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable <span class="go-doc-concept go-doc-disease">Breast Cancer</span> and Low Recurrence Score

Title

  • Brief Title: Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
  • Official Title: Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
  • Clinical Trial IDs

    NCT ID: NCT02476786

    ORG ID: 15-x149

    Trial Conditions

    Breast Cancer

    Cancer of Breast

    Breast Neoplasms

    Cancer of the Breast

    Trial Interventions

    Drug Synonyms Arms
    Goserelin Goserelin acetate, Zoladex Arm 1: Endocrine therapy alone
    Anastrozole Arimidex Arm 1: Endocrine therapy alone
    Exemestane Aromasin Arm 1: Endocrine therapy alone
    Fulvestrant Faslodex Arm 1: Endocrine therapy alone
    Tamoxifen Nolvadex Arm 1: Endocrine therapy alone

    Trial Purpose

    Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can
    be identified. A new standard of care needs to be defined for elderly women with good
    prognosis 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 75 or older with ER+ breast cancer and low recurrence scores.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm 1: Endocrine therapy alone Experimental Previously collected tissue will be requested and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score generated by the Oncotype DX assay predicts chemotherapy benefit and indicates the 10-year risk of recurrence. Recurrence scores under 18 are considered "low risk." Patients whose scores are < 18 will receive endocrine therapy only. 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 tamoxifen Goserelin, Anastrozole, Exemestane, Fulvestrant, Tamoxifen
    Arm 2: Standard of care treatment Active Comparator Previously collected tissue will be requested and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score generated by the Oncotype DX assay predicts chemotherapy benefit and indicates the 10-year risk of recurrence. Recurrence scores under 18 are considered "low risk." Patients whose scores are 18 will be treated as per standard of care. Standard of care treatment generally consists of surgery followed by possible chemotherapy or radiation therapy and endocrine therapy. The only intervention that this arm will receive will be review of chart annually for recurrence status and survival. The participants will also need to fill out the FACT-B questionnaire at baseline and once a year for 10 years.

    Eligibility Criteria

    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+ (Allred score 5) and HER2-.

    - Measurable disease defined as lesions that can be accurately measured in at least one
    dimension (longest diameter to be recorded) by ultrasound or mammogram.

    - 75 years of age or older.

    - ECOG performance status 2

    - 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 chemotherapy and/or hormone therapy for 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.

    Minimum Eligible Age: 75 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Rate of loco-regional progression

    Secondary Outcome Measures

    Breast cancer-specific survival

    Rate of overall survival

    Correlate response to treatment with recurrence score

    Trial Keywords