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

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ClinicalTrials.gov Identifier: NCT02476786
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Genomic Health®, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer of Breast Breast Neoplasms Cancer of the Breast Behavioral: FACT-B Drug: Goserelin Drug: Anastrozole Drug: Exemestane Drug: Fulvestrant Drug: Tamoxifen Other: Archived tissue collection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Breast cancer-specific survival [ Time Frame: 6 months ]
  2. Breast cancer-specific survival [ Time Frame: 1 year ]
  3. Breast cancer-specific survival [ Time Frame: 2 years ]
  4. Rate of overall survival [ Time Frame: 5 years ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476786


Contacts
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Contact: Rebecca L Aft, M.D., Ph.D. 314-747-0063 aftr@wustl.edu
Contact: Tracie Guthrie 314-747-4404 guthriet@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Rebecca L Aft, M.D., Ph.D.    314-747-0063    aftr@wustl.edu   
Contact: Tracey Guthrie    314-747-4404    guthriet@wustl.edu   
Principal Investigator: Rebecca L Aft, M.D., Ph.D.         
Sub-Investigator: Foluso Ademuyiwa, M.D.         
Sub-Investigator: Ron Bose, M.D., Ph.D.         
Sub-Investigator: Amy Cyr, M.D.         
Sub-Investigator: Timothy Eberlein, M.D.         
Sub-Investigator: William Gillanders, M.D.         
Sub-Investigator: Cynthia X Ma, M.D., Ph.D.         
Sub-Investigator: Julie Margenthaler, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Katherine N Weilbaecher, M.D.         
Sub-Investigator: Leonel Hernandez-Aya, M.D.         
Sub-Investigator: Peter Oppelt, M.D.         
Sub-Investigator: Antonella Rastelli, M.D.         
Sub-Investigator: Caron Rigden, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Genomic Health®, Inc.
Investigators
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Principal Investigator: Rebecca L Aft, M.D, Ph.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02476786     History of Changes
Other Study ID Numbers: 201611010
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Estrogens
Tamoxifen
Fulvestrant
Exemestane
Anastrozole
Goserelin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Estrogen Receptor Antagonists
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action