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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02476786
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : February 10, 2021
Genomic Health®, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 17, 2015
First Posted Date  ICMJE June 19, 2015
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE January 17, 2017
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
Response rate [ Time Frame: 6 months ]
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
Rate of loco-regional progression [ Time Frame: 5 years ]
-Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • Breast cancer-specific survival [ Time Frame: 6 months ]
  • Breast cancer-specific survival [ Time Frame: 1 year ]
  • Breast cancer-specific survival [ Time Frame: 2 years ]
  • Rate of overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
  • Breast cancer-specific survival [ Time Frame: 5 years ]
  • Rate of overall survival [ Time Frame: 5 years ]
  • Correlate response to treatment with recurrence score [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
Official Title  ICMJE Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Cancer of Breast
  • Breast Neoplasms
  • Cancer of the Breast
Intervention  ICMJE
  • Behavioral: FACT-B
    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).
  • Drug: Goserelin
    Other Names:
    • Goserelin acetate
    • Zoladex
  • Drug: Anastrozole
    Other Name: Arimidex®
  • Drug: Exemestane
    Other Name: Aromasin®
  • Drug: Fulvestrant
    Other Name: Faslodex®
  • Drug: Tamoxifen
    Other Name: Nolvadex®
  • Other: Archived tissue collection
Study Arms  ICMJE Experimental: Endocrine therapy alone
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2015)
Estimated Study Completion Date  ICMJE January 31, 2028
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca L Aft, M.D., Ph.D. 314-747-0063
Contact: Tracie Guthrie 314-747-4404
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02476786
Other Study ID Numbers  ICMJE 201611010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Genomic Health®, Inc.
Investigators  ICMJE
Principal Investigator: Rebecca L Aft, M.D, Ph.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP