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Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women (LETTER)

This study is currently recruiting participants.
Verified May 2011 by Korean Breast Cancer Study Group
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01069211
First received: February 14, 2010
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Phase
Breast Cancer
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: the first 5 years after enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse effect [ Time Frame: the first 5 years after enrollment ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: the first 5 years after enrollment ] [ Designated as safety issue: Yes ]
  • Time to Distant Recurrence (TTDR) [ Time Frame: the first 5 years after enrollment ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Breast Cancer Tissue


Estimated Enrollment: 876
Study Start Date: January 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

This study aimed at evaluating following:

  1. Validity Assessment:

    1. Primary End Point: To evaluate 5-year diseae free survival rate after Letrozole treatment according to the estrogen receptor expression in postmenopausal women
    2. Secondary End Point: To evaluate overall survival rate(OS) and Time to distance recurrence(TTDR) after Hormonal therapy in postmenopausal women with hormone receptor positive breast cancer
  2. Safety Assessment: To evaluate all adverse events including serious adverse events after Letrozole treatment.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Patients with estrogen receptor(+) and/or progesterone receptor(+)

  2. Postmenopausal state was defined the following conditions, at least one of a, b

    1. Serum FSH ≥ 30 mIU/mL and Amenorrhea ≥ 1 year for below 55 years, over than 55 years
    2. Bilateral oophorectomy
  3. Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
  4. WHO(ECOG) performance status 0-2
  5. Adequate haematological function, renal function, hepatic function.
  6. No evidence of metastasis.

Exclusion Criteria:

  1. Metachronous bilateral breast cancer.
  2. Metastatic breast cancer (stage IV)
  3. Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream.
  4. Patients with Child-Pugh grade C, serum creatinine>2xUNL
  5. Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069211

Contacts
Contact: Ku Sang Kim, MD 82-31-219-5200 ideakims@gmail.com

Locations
Korea, Republic of
Joon Jeong Recruiting
Seoul, Korea, Republic of
Contact: Joon Jeong, MD     82-2-2019 - 3300     gsjjoon@yumc.yonsei.ac.kr    
Sponsors and Collaborators
Korean Breast Cancer Study Group
Investigators
Principal Investigator: Joon Jeong, MD Department of Surgery, Gangnam Severance Hospital, South Korea
  More Information

No publications provided

Responsible Party: Joon Jeong, Gangnam Severance Hospital, South Korea.
ClinicalTrials.gov Identifier: NCT01069211     History of Changes
Other Study ID Numbers: KBCSG006
Study First Received: February 14, 2010
Last Updated: May 10, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Breast Cancer Study Group:
Breast cancer, Letrozole
postmenopause
hormone receptor positive breast cancer

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
 Letrozole
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013