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Recruiting NCT02476786

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

Phase II Interventional Breast Cancer Cancer of Breast Breast Neoplasms Cancer of the Breast

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FACT-B, Goserelin, Anastrozole, Exemestane.
Who it may be relevant to
Registry conditions: Breast Cancer, Cancer of Breast, Breast Neoplasms, Cancer of the Breast. Basic parameters: from 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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).
  • Drug Goserelin
  • Drug Anastrozole
  • Drug Exemestane
  • Drug Fulvestrant
  • Drug Tamoxifen
  • Other Archived tissue collection

Primary outcome measures

  • Response rate [Time frame: 6 months]
Secondary outcome measures (4)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT02476786 · 201611010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗