Letrozole in the Treatment of Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer (deFEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171808
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

In Western industrialized countries, endometrial cancer is the most common malignancy of the female reproductive tract.

The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy. This trial will investigate the efficacy and safety of letrozole in the treatment of advanced or recurrent hormone receptor-positive endometrial cancer .

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: Letrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study on Letrozole in Patients With Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer
Study Start Date : April 2005
Actual Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole Drug: Letrozole

Primary Outcome Measures :
  1. clinical response rate (partial response PR and complete response CR) according to RECIST at least once during the treatment period [ Time Frame: until disease progression ]

Secondary Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: until disease progression ]
  2. Overall survival (OS) [ Time Frame: until disease progression ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • Age > 18 years
  • Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the endometrium
  • Presence of advanced or recurrent endometrial cancer, FIGO stage I-IV, incurable with surgery and/or radiation therapy
  • Documented ER and/or PgR positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating laboratory.
  • Patient must be postmenopausal defined as

    • Age ≥55 years.
    • Age <55 but no spontaneous menses for at least 1 year.
    • Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (<5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved.
    • Bilateral oophorectomy
    • Radiation menopause
  • Presence of measurable disease (by clinical/radiological examination - according to RECIST criteria : minimum indicator lesion size : 20 mm (unless spiral CT scan in which case > 10 mm)
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow function (WBC ≥ 3.5 x 1'000'000'000/L and platelets ≥ 100.0 x 1'000'000'000/L) and hemoglobin > 10.0 g/dl
  • Adequate renal function (creatinine < 120 µmol/L) and hepatic function (bilirubin < 25 µmol/L, AST (SGOT < 60 U/L)
  • Minimum life expectancy of at least 6 months
  • Patients who are accessible for treatment and follow-up

Exclusion Criteria:

  • Presence of non-measurable disease only
  • Other concomitant anti-cancer treatment (except external radiation treatment [XRT] for symptomatic metastatic lesions if other assessable untreated lesions are present)
  • Prior treatment with aromatase inhibitors or anti-estrogens (up to one previous progestational hormone therapy regimen for recurrent disease is permitted)
  • Clear cell or papillary serous histology, uterine sarcomas, mixed Mullerian tumors (MMT) and/or adenosarcomas
  • Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin`s disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence
  • Known central nervous system (CNS) metastases, bilateral diffuse lymphangiosis carcinoma of the lung (>50 % of lung involvement, or dyspnea at rest requiring supplemental oxygen therapy), evidence of metastases estimated as more than a third of the liver as defined by sonogram and/or CT scan
  • Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing`s Syndrome, Addison`s disease (treated or untreated)
  • Unstable angina and uncontrolled cardiac disease
  • Treatment with other investigational drugs (drugs not marketed for any indication) within the past 30 days and/or the concomitant use of investigational drugs
  • A history of non-compliance to medical regimens and patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study
  • Inability to swallow pills

Additional protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171808

Ebersberg, Germany
Celle, Germany
Heidelberg, Germany
Ebersberg, Germany
Novartis Investigative Site
Freiburg, Germany
Ebersberg, Germany
Hamburg, Germany
Novartis Investigative Site
Hamburg, Germany
Celle, Germany
Hannover, Germany
Tuebingen, Germany
Heidelberg, Germany
Novartis Investigative Site
Karlsruhe, Germany
Muenchen, Germany
Kiel, Germany
Muenchen, Germany
Muenchen, Germany
Novartis Investigative Site
Muenchen, Germany
Novartis Investigative Site
Oberaudorf, Germany
Novartis Investigative Site
Rostock, Germany
Novartis Investigative Site
Tuebingen, Germany
Hannover, Germany
Wolfsburg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00171808     History of Changes
Other Study ID Numbers: CFEM345ADE08
EudraCT-Number: 2004-003886-34 ( Registry Identifier: EudraCT )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Endometrial Cancer
Aromatase inhibitor
Advanced or recurrent
hormone receptor positive

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists