PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL EVALUATING THE USE OF ADJUVANT ENDOCRINE THERAPY +/- ONE YEAR OF EVEROLIMUS IN PATIENTS WITH HIGH-RISK, HORMONE RECEPTOR-POSITIVE AND HER2/NEU NEGATIVE BREAST CANCER.

  • STATUS
    Recruiting
  • sponsor
    SWOG
Updated on 24 November 2020
breast cancer
endocrine therapy
hormone therapy
HER2
erbb2

Summary

PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL EVALUATING THE USE OF ADJUVANT ENDOCRINE THERAPY +/- ONE YEAR OF EVEROLIMUS IN PATIENTS WITH HIGH-RISK, HORMONE RECEPTOR-POSITIVE AND HER2/NEU NEGATIVE BREAST CANCER.

Description

You are being asked to take part in this study because you are a woman/man with hormone responsive breast cancer that has already been removed by surgery and you have completed any required chemotherapy or radiation.

The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer or breast cancer. It is considered investigational for non-metastatic breast cancer patients. In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.

Details
Condition Breast Cancer
Clinical Study IdentifierTX143711
SponsorSWOG
Last Modified on24 November 2020

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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