Clinical trial NCT02476786: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Cancer of Breast
Breast Neoplasms
Cancer of the Breast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Genomic Health®, Inc.
First posted: 2015-06-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Response rate
timeFrame: 6 months
Secondary outcomes:
measure: Breast cancer-specific survival
timeFrame: 6 months
measure: Breast cancer-specific survival
timeFrame: 1 year
measure: Breast cancer-specific survival
timeFrame: 2 years
measure: Rate of overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rebecca L Aft, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: