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

Primary Purpose

Breast Cancer, Cancer of Breast, Breast Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FACT-B
Goserelin
Anastrozole
Exemestane
Fulvestrant
Tamoxifen
Archived tissue collection
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endocrine therapy alone

Arm 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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Breast cancer-specific survival
Breast cancer-specific survival
Breast cancer-specific survival
Rate of overall survival

Full Information

First Posted
June 17, 2015
Last Updated
December 14, 2022
Sponsor
Washington University School of Medicine
Collaborators
Genomic Health®, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02476786
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
January 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Genomic Health®, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer of Breast, Breast Neoplasms, Cancer of the Breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endocrine therapy alone
Arm Type
Experimental
Arm 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)
Intervention Type
Behavioral
Intervention Name(s)
FACT-B
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Goserelin
Other Intervention Name(s)
Goserelin acetate, Zoladex
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Other Intervention Name(s)
Arimidex®
Intervention Type
Drug
Intervention Name(s)
Exemestane
Other Intervention Name(s)
Aromasin®
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex®
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
Nolvadex®
Intervention Type
Other
Intervention Name(s)
Archived tissue collection
Primary Outcome Measure Information:
Title
Response rate
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Breast cancer-specific survival
Time Frame
6 months
Title
Breast cancer-specific survival
Time Frame
1 year
Title
Breast cancer-specific survival
Time Frame
2 years
Title
Rate of overall survival
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca L Aft, M.D., Ph.D.
Phone
314-747-0063
Email
aftr@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tracie Guthrie
Phone
314-747-4404
Email
guthriet@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L Aft, M.D, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca L Aft, M.D., Ph.D.
Phone
314-747-0063
Email
aftr@wustl.edu
First Name & Middle Initial & Last Name & Degree
Tracey Guthrie
Phone
314-747-4404
Email
guthriet@wustl.edu
First Name & Middle Initial & Last Name & Degree
Rebecca L Aft, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Foluso Ademuyiwa, M.D.
First Name & Middle Initial & Last Name & Degree
Ron Bose, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Andrew Davis, M.D.
First Name & Middle Initial & Last Name & Degree
William Gillanders, M.D.
First Name & Middle Initial & Last Name & Degree
Cynthia X Ma, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Julie Margenthaler, M.D.
First Name & Middle Initial & Last Name & Degree
Rama Suresh, M.D.
First Name & Middle Initial & Last Name & Degree
Katherine N Weilbaecher, M.D.
First Name & Middle Initial & Last Name & Degree
Ashley Frith, M.D.
First Name & Middle Initial & Last Name & Degree
Peter Oppelt, M.D.
First Name & Middle Initial & Last Name & Degree
Antonella Rastelli, M.D.
First Name & Middle Initial & Last Name & Degree
Caron Rigden, M.D.
First Name & Middle Initial & Last Name & Degree
Lindsay Peterson, M.D.
First Name & Middle Initial & Last Name & Degree
Fei Wan, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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