NCT01614210

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 13, 2017

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

4.3 years

First QC Date

June 4, 2012

Results QC Date

July 28, 2017

Last Update Submit

July 5, 2018

Conditions

Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in Ki67 Expression in Tumors

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

    7 days

Secondary Outcomes (3)

  • Change in FACT-ES Symptom Scores

    18 months

  • Number of Participants With Long Term Endocrine Therapy Adherence

    18 months

  • Correlation Between Changes in Ki67 and Symptoms

    7 days

Other Outcomes (1)

  • Change in FACT-ES Symptom Scores

    7 days

Study Arms (1)

All patients

EXPERIMENTAL

All patients enrolled in the study.

Drug: TamoxifenProcedure: Breast cancer surgery

Interventions

TamoxifenDRUG

All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.

All patients
Breast cancer surgeryPROCEDURE

Breast cancer surgery

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Tamoxifen

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Josiah Hawks
Organization
Huntsman Cancer Institute
Josiah.Hawks@hci.utah.edu
8015850601

Study Officials

  • Leigh Neumayer, MD

    Huntsman Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 7, 2012

Study Start

August 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

August 1, 2018

Results First Posted

December 13, 2017

Record last verified: 2018-07

Locations

US(1)