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Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

Phase 2
18 Years
Open (Enrolling)
Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer

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Trial Information

Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

Patients who are eligible (newly diagnosed hormone positive clinical stage 1 or 2 breast
cancer) will be approached about the study. If they sign informed consent a prescription for
21 doses of Tamoxifen will be provided. The patient's surgery will be scheduled at a time
convenient for the patient and the surgeon. Once the surgery has been scheduled, a
medication calendar will be completed that allows the patient to take tamoxifen for 7 days
preoperatively with the 7th dose of tamoxifen to coincide with the day before surgery. The
patient will continue to take tamoxifen for 2 weeks (14 days) after surgery. Patients will
then proceed along normal treatment guidelines. For those needing chemotherapy or radiation
therapy, we recommend the long term endocrine therapy start at the conclusion of chemo
and/or radiation treatments. For those not going on to any additional therapy, the
prescription for endocrine therapy will be written at the initial post-operative visit.

Unstained slides from the formalin-fixed, paraffin-embedded tissue blocks from the patient's
breast tissue from which the original diagnosis of breast cancer was made by H&E will be
stained for Ki67. After endocrine therapy and subsequent resection, carcinoma will be
confirmed by the participating pathologist on H&E, and Ki67 will be performed on unstained
slides from a representative tissue block containing invasive carcinoma. The pathologist
will circle a designated area of tumor on the H&E slide and both the H&E and immunostained
(Ki67) slides will be scanned in a digital imaging device (Aperio XT Scanscope), which
quantitatively analyzes the tumor designated by the pathologist with image analysis
algorithms. The algorithm accurately detects regions of interest and distinguishes cells and
sub-cellular objects within these target regions. It determines morphology and expression
profiles per individual cell or cell compartment. For Ki67 analysis, a nuclear
Immunohistochemistry (IHC) algorithm will be used.

Inclusion Criteria:

- Age > 18 years old

- Diagnosed with hormone receptor positive invasive breast cancer (ER or PR or both
>1%) by core needle biopsy

- Clinical AJCC 7th edition Stage 1 or 2

- Candidate for surgical therapy

- ECOG performance status 0,1, or 2

- No prior therapy for breast cancer

- Paraffin fixed core needle tissue block, 1-3 unstained slides or biopsy punch
available for central analysis for proliferative markers

- Not pregnant or lactating and practicing adequate birth control if premenopausal

- Able to provide informed consent and have signed an approved consent form that
conforms to federal and institutional guidelines

Exclusion Criteria:

- Prior history of uterine cancer

- Prior personal history of stroke or DVT

- Current therapy with strong CYP2D6 inhibitors The following medications should not be
administered with tamoxifen (21 day treatment period) and will need to be stopped for
the designated period of time prior to starting the study tamoxifen.

Fluoxetine - should be discontinued 30 days prior to starting tamoxifen Paroxetine -
should be discontinued 5 days prior to starting tamoxifen Sertraline - should be
discontinued 5 days prior to starting tamoxifen Bupropion - should be discontinued 5 days
prior to starting tamoxifen

- Concurrent coumarin-type anticoagulation therapy

- Any other contraindications to tamoxifen therapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction in Ki67 expression in tumors

Outcome Description:

Demonstrate a significant reduction in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Leigh Neumayer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2012

Completion Date:

July 2015

Related Keywords:

  • Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer
  • Breast Neoplasms



Huntsman Cancer Institute Salt Lake City, Utah  84112