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LoTamRandomPhIII LowDosTamoxifenSelectPa w/MolecularLowRiskEarlyStageBreastCa

UCI Specialty Area: Cancer
Principal Investigator: Ritesh Parajuli
Official Title: LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer
A Study On:
Breast

Study Description

PRIMARY OBJECTIVE:

To evaluate whether the recurrence-free interval (RFI) with low-dose tamoxifen is non-inferior to standard-of-care endocrine therapy among post-menopausal women with early-stage, low molecular risk breast cancer.

Eligibility

KEY ELIGIBILITY CRITERIA:

  1. Histologically confirmed unilateral invasive adenocarcinoma, HER2 negative
  2. Tumor size not larger than 3 cm
  3. No definitive clinical or radiologic evidence of metastatic disease
  4. Must be intending to take at least 5 years of endocrine therapy
  5. Confirmed postmenopausal status
  6. No abnormal or dysfunctional uterine bleeding within 1 year of study enrollment
  7. No concurrent treatment with any endocrine therapy for breast cancer prevention or osteoporosis, including raloxifene, tamoxifen, or other selective estrogen receptor modulator.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
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    You may choose to skip any question. You may refuse to participate or discontinue your involvement
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    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
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  • There are no alternative procedures available. The only alternative is not to participate in this study.
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  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI