Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

Completed · Phase 2

Conditions studied: Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer

In brief

The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.

Key facts

Study ID

NCT01614210

Run by

University of Utah

People needed

52

Starts

2012-08-01

Expected to finish

2016-11-01

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years old
• Diagnosed with hormone receptor positive invasive breast cancer (estrogen receptor (ER) or progesterone receptor (PR) or both >1%) by core needle biopsy
• Clinical American Joint Committee on Cancer (AJCC) 7th edition Stage 1 or 2
• Candidate for surgical therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
• No chemotherapy or endocrine therapy for breast cancer in last 5 years
• Paraffin fixed core needle tissue block, or biopsy punch available for central analysis for proliferative markers
• Not pregnant or lactating and practicing adequate birth control if premenopausal
• Able and willing to provide informed consent

You may not qualify if…

• Prior personal history of uterine cancer
• Prior personal history of stroke or deep vein thrombosis (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.
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
• 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

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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