Know Cancer

forgot password

Phase II Study on Letrozole in Patients With Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

Phase II Study on Letrozole in Patients With Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer

Inclusion Criteria:

- Signed informed consent

- Age > 18 years

- Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical response rate (partial response PR and complete response CR) according to RECIST at least once during the treatment period

Outcome Time Frame:

until disease progression

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Aromatase inhibitor
  • Advanced or recurrent
  • hormone receptor positive
  • endometrial cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma