Endocrine Treatment Alone for Elderly Patients With Estro... | NCT02476786 | Trialant
NCT02476786
Sponsor
Washington University School of Medicine
Status
Recruiting
Last Update Posted
Jul 28, 2025Actual
Enrollment
50Estimated
Phase
Phase 2
Conditions
Breast Cancer
Cancer of Breast
Breast Neoplasms
Cancer of the Breast
Interventions
FACT-B
Goserelin
Anastrozole
Exemestane
Fulvestrant
Tamoxifen
Archived tissue collection
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02476786
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
201611010
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
Washington University School of MedicineOTHER
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 17, 2017Actual
Primary Completion Date
Jan 31, 2027Estimated
Completion Date
Jul 31, 2032Estimated
First Submitted Date
Jun 17, 2015
First Submission Date that Met QC Criteria
Jun 17, 2015
First Posted Date
Jun 19, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 23, 2025
Last Update Posted Date
Jul 28, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Washington University School of MedicineOTHER
Collaborators
Name
Class
Genomic Health®, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Cancer
Cancer of Breast
Breast Neoplasms
Cancer of the Breast
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
50Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Endocrine therapy alone
Experimental
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)
Behavioral: FACT-B
Drug: Goserelin
Drug: Anastrozole
Drug: Exemestane
Drug: Fulvestrant
Drug: Tamoxifen
Other: Archived tissue collection
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FACT-B
Behavioral
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).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Response rate
Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].
In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores <18 indicating low risk.
6 months
Secondary Outcomes
Measure
Description
Time Frame
Breast cancer-specific survival
6 months
Breast cancer-specific survival
1 year
Breast cancer-specific survival
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
70 Years
Maximum Age
Not provided
Standard Ages
Older Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Name
Role
Phone
Extension
Email
Rebecca L Aft, M.D., Ph.D.
Contact
314-747-0063
aftr@wustl.edu
Tracie Guthrie
Contact
314-747-4404
guthriet@wustl.edu
Overall Officials
Name
Affiliation
Role
Rebecca L Aft, M.D, Ph.D.
Washington University School of Medicine
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Washington University School of Medicine
Recruiting
St Louis
Missouri
63110
United States
References Module
Citations
Not provided
See Also Links
Label
URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine