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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
70 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether hormone-blocking treatment alone can control breast cancer in women age 70 or older. It is for women whose cancer uses estrogen to grow, can be removed by surgery, and has a low level of cancer cell growth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 70 or older.
  • Newly diagnosed breast cancer confirmed by a tissue or cell test. The cancer has grown into nearby breast tissue and can be removed by surgery.
  • Cancer stage T1 or T2, N0 or N1, and M0: limited tumor size and nearby lymph node spread, with no spread to distant body parts.
  • Cancer is ER-positive (uses estrogen to grow) and HER2-negative (does not have high levels of the HER2 protein).
  • Ki67 score of 30% or less, or a low to medium rate of cells dividing. These tests show how fast cancer cells grow.
  • The tumor can be measured on an ultrasound or mammogram.
  • ECOG activity score of 3 or less: able to do at least some self-care, even if in bed or a chair for much of the day.
  • Able to understand and willing to sign the study consent form, or have a legally authorized person do so when allowed.

Who can't join

  • Already had surgery for this breast cancer.
  • Had another cancer within the past 5 years that would prevent hormone-blocking treatment.
  • Currently taking another experimental treatment.
  • Past allergic reaction to a drug similar to a study drug.
  • An illness that is not under control and, in the treating doctor's judgment, would make it hard to follow study requirements.
  • Known HIV infection treated with a combination of HIV medicines, because these may interact with hormone-blocking treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

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