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Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance (POWER PIINC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614210
First Posted: June 7, 2012
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  Purpose
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.

Condition Intervention Phase
Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer Drug: Tamoxifen Procedure: Breast cancer surgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change in Ki67 Expression in Tumors [ Time Frame: 7 days ]
    Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.


Secondary Outcome Measures:
  • Evaluate Symptom Patterns [ Time Frame: 18 months ]
    Evaluate symptom patterns from baseline through 18 months of follow-up (presence, severity, and bother)

  • Adherence [ Time Frame: 18 months ]
    Evaluate 18-month endocrine therapy adherence

  • Correlation Between Changes in Ki67 and Symptoms [ Time Frame: 7 days ]
    Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in KI67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient.


Enrollment: 52
Study Start Date: August 2012
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All patients enrolled in the study.
Drug: Tamoxifen
All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.
Procedure: Breast cancer surgery
Breast cancer surgery

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Exclusion Criteria:

  • Prior personal 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.

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614210


Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Leigh Neumayer, MD Huntsman Cancer Institute
  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01614210     History of Changes
Other Study ID Numbers: HCI57098
First Submitted: June 4, 2012
First Posted: June 7, 2012
Results First Submitted: July 28, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents