NCT02806544

Brief Summary

This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2 breast-cancer

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

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 17, 2016

Completed
Last Updated

January 30, 2017

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

June 16, 2016

Results QC Date

July 22, 2016

Last Update Submit

December 1, 2016

Conditions

Breast CancerBreast Neoplasms

Keywords

Breast neoplasmsBreast cancerLocally advanced breast cancerNeoadjuvant endocrine therapyTamoxifenLow and middle income country

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility

    Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.

    4-6 months

Secondary Outcomes (5)

  • Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen

    4-6 months

  • Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy

    4-6 weeks

  • Overall Clinical Response Rate

    4-6 months

  • Pathologic Complete Response

    4-6 months

  • Breast Conserving Therapy

    4-6 months

Study Arms (1)

Tamoxifen

EXPERIMENTAL

Tamoxifen 20mg by mouth daily

Drug: Tamoxifen

Interventions

TamoxifenDRUG

Tamoxifen 20mg by mouth daily

Tamoxifen

Eligibility Criteria

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

You may qualify if:

  • Patient evaluated and treated at INCAN
  • Patients must provide informed consent
  • Patient must be ≥ 18 years of age.
  • Life expectancy ≥ 6 months
  • Clinical locally advance breast cancer (Stage IIB or III)
  • Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score \> 4
  • Patient must have an ECOG Performance Status of 0-2
  • Patients must be able to swallow and retain oral medication

You may not qualify if:

  • Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years
  • Patient must not be pregnant or nursing
  • Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
  • Women of childbearing age unable or unwilling to use contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Laila Agrawal
Organization
Vanderbilt University
laila.saied@vanderbilt.edu
615-322-4967

Study Officials

  • Laila Agrawal, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 20, 2016

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 30, 2017

Results First Posted

November 17, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share