NCT01069211

Brief Summary

The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
876

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

7 years

First QC Date

February 14, 2010

Last Update Submit

May 10, 2011

Conditions

Breast Cancer

Keywords

Breast cancer, Letrozolepostmenopausehormone receptor positive breast cancer

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    the first 5 years after enrollment

Secondary Outcomes (3)

  • Adverse effect

    the first 5 years after enrollment

  • Overall Survival

    the first 5 years after enrollment

  • Time to Distant Recurrence (TTDR)

    the first 5 years after enrollment

Study Arms (3)

ER expression : Low

Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 3 or 4 point of total Allred score.

ER expression : Intermediate

Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 5 or 6 point of total Allred score.

ER expression : High

Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 7 or 8 point of total Allred score.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients recruited into the study are postmenopausal women with estrogen receptor positive breast cancer.

You may qualify if:

  • Patients with estrogen receptor(+) and/or progesterone receptor(+)
  • Postmenopausal state was defined the following conditions, at least one of a, b
  • Serum FSH ≥ 30 mIU/mL and Amenorrhea ≥ 1 year for below 55 years, over than 55 years
  • Bilateral oophorectomy
  • Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
  • WHO(ECOG) performance status 0-2
  • Adequate haematological function, renal function, hepatic function.
  • No evidence of metastasis.

You may not qualify if:

  • Metachronous bilateral breast cancer.
  • Metastatic breast cancer (stage IV)
  • Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream.
  • Patients with Child-Pugh grade C, serum creatinine\>2xUNL
  • Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joon Jeong

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Ahn SG, Nam SJ, Ahn SH, Jung Y, Park HK, Lee SJ, Kang SS, Han W, Park KH, Park YL, Lee J, Youn HJ, Kim JH, Yoo Y, Song JY, Ko BK, Gwak G, Chung MS, Kim SY, Cho SH, Kim D, Chang MC, Moon BI, Kim LS, Kim SJ, Park MH, Kim TH, Cho J, Lim CW, Bae YT, Gong G, Bae YK, Lee A, Jeong J. Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006). J Breast Cancer. 2021 Apr;24(2):164-174. doi: 10.4048/jbc.2021.24.e17. Epub 2021 Mar 25.

    PMID: 33818022DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast Cancer Tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Joon Jeong, MD

    Department of Surgery, Gangnam Severance Hospital, South Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ku Sang Kim, MD

CONTACT

82-31-219-5200ideakims@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2010

First Posted

February 17, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations

KR(1)