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

The Washington University

Status and phase

Enrolling

Phase 2

Conditions

Cancer of Breast

Breast Cancer

Cancer of the Breast

Breast Neoplasms

Treatments

Behavioral: FACT-B

Other: Archived tissue collection

Drug: Anastrozole

Drug: Tamoxifen

Drug: Fulvestrant

Drug: Exemestane

Drug: Goserelin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02476786

201611010

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Endocrine therapy alone

Experimental group

Description:

* Neoadjuvant 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, or tamoxifen * Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment * After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy * Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire * Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)