A Study to Measure the Proteins Expressed in tissue Samples from Women who have been Treated with New Endocrine Therapy for Invasive Lobular Breast Cancer

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-002867
    NCT ID: NCT02206984
    Sponsor Protocol Number: TBCRC037

About this study

 

The purpose of this study is to compare the effectiveness of fulvestrant to anastrozole or tamoxifen in treating invasive lobular breast cancer, by measuring the level of the biomarker Ki67 found in tumor tissue before and then after treatment.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Female
  • Must be fully postmenopausal
  • Histologically confirmed invasive lobular breast cancer
    • Excluding pleomorphic and HER-2 positive lobular cancer
    • Measuring at least 1 centimeter (cm) radiographically or clinically
    • Clinical stages I-III
      • See Appendix A for staging criteria
  • Invasive lobular histology will be diagnosed at the enrolling institution for purposes of study participation
  • Invasive lobular histology will be confirmed by central pathology review, but this central review will not be required prior to enrollment
  • Prior to initiation of study agents, participant must agree to both a baseline and a second post-treatment research core biopsy
    • The second biopsy can be removed from tissue excised during surgery
  • Hormone receptor (HR) status of the invasive component must be documented on the diagnostic core biopsy before trial enrollment
  • The tumor must be ER-positive
    • ER will be considered positive if staining is 1% or greater
    • This will be determined at the enrolling institution for purposes of study participation and enrollment onto the trial
  • HR status will be confirmed by central pathology review, but this central review will not be required prior to enrollment 
  • ECOG performance status of 0, 1 or 2
  • Adequate organ and marrow function as defined below
    • Leukocytes >3,000/mm3
    • Absolute neutrophil count >1,500/mm3
    • Platelets >100,000/mm3
    • Total bilirubin within normal laboratory limits
    • AST(SGOT)/ALT(SGPT) <2.5 times the laboratory upper limit of normal
    • Creatinine within normal laboratory limits
  • Prior use of hormone contraceptives and replacement therapy is allowed (e.g., estrogen and/or progestin), but must have been discontinued at least 30 days prior to the diagnostic biopsy
  • Vaginal preparations (e.g., Vagifem® or Estring®) are allowed
  • Must be aware of the nature of malignancy, understand the study requirements and risks and be able and willing to sign a written informed consent document

Exclusion Criteria

  • Prior or concurrent use of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer, including any history of prior irradiation to the ipsilateral breast
  • Concurrent use of any other investigational agents
  • History of allergic reactions/hypersensitivity attributed to compounds of similar chemical or biologic composition to tamoxifen, anastrozole, or fulvestrant or any of their ingredients
  • History of thromboembolic disease or uterine cancer that is considered a contraindication to tamoxifen
  • Active hepatitis viral infections
  • Uncontrolled current illness including, but not limited to
    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • Invasive lobular carcinoma of pleomorphic subtype
  • HER-2 positivity

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tina Hieken, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions