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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01614210
First received: June 4, 2012
Last updated: July 2, 2014
Last verified: July 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Reduction in Ki67 expression in tumors [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Demonstrate a significant reduction in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.


Secondary Outcome Measures:
  • Evaluate symptom patterns [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Evaluate symptom patterns from baseline through 18 months of follow-up (presence, severity, and bother)

  • Adherence [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Evaluate 18-month endocrine therapy adherence

  • Correlation between changes in Ki67 and symptoms [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Evaluate correlation between changes in Ki67 expression and symptom scores


Estimated Enrollment: 52
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614210

Contacts
Contact: Emily Ostrander 801-587-4567 emily.ostrander@hci.utah.edu

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

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01614210     History of Changes
Other Study ID Numbers: HCI57098
Study First Received: June 4, 2012
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 22, 2014