Exemestane in Advanced and Recurrent Endometrial Carcinoma

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: Exemestane

Study type: Interventional

Funder types: Other

Identifiers

NCT01965080

NSGO-EC-0302

Details and patient eligibility

About

A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma

Hypothesis: Treatment With Exemestane can give a response rate of at least 30%

Full description

Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily.

Patients were grouped according to estrogen receptor status.

Enrollment: 52 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment
• Endometrioid histology
• Age above 18 years
• Post menopausal status
• Performance status 0-2
• Informed consent

Exclusion criteria

• Congestive heart disease grade III.IV
• History of thromboembolic signs
• Other primary hormonal therapy
• Patients With symptomatic brain metastasis
• Severe hepatic or renal impairment
• Pregnancy, lactation or child bearing potential without adequate contraception

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Exemestane

Experimental group

Description:

Exemestane 25 mg daily

Treatment:

Drug: Exemestane