Know Cancer

or
forgot password

Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer


Phase 4
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Disease free survival

Outcome Time Frame:

the first 5 years after enrollment

Safety Issue:

Yes

Principal Investigator

Joon Jeong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Gangnam Severance Hospital, South Korea

Authority:

Korea: Food and Drug Administration

Study ID:

KBCSG006

NCT ID:

NCT01069211

Start Date:

January 2010

Completion Date:

January 2017

Related Keywords:

  • Breast Cancer
  • Breast cancer, Letrozole
  • postmenopause
  • hormone receptor positive breast cancer
  • Breast Neoplasms

Name

Location