Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00002777
• Date of registration: 01/11/1999
• Prospective Registration: No
• Primary sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Public title: Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
• Scientific title: RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS
• Date of first enrolment: May 1996
• Target sample size: 342
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002777
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, France, Malaysia, Netherlands, Philippines, Poland, Russian Federation, Slovenia, Taiwan, Thailand, United Kingdom

Contacts

• Name: Robert Paridaens, MD, PhD
• Affiliation: U.Z. Gasthuisberg

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically proven adenocarcinoma of the breast that is
metastatic and progressive or locally recurrent and inoperable

- At least one bidimensionally measurable or evaluable lesion

- Lytic bone lesions on x-ray/CT scan, surrounded by calcified bone, and at least
1 cm

- Bidimensionally measurable extraosseous disease required for patients on
bisphosphonates

- The following are not considered evaluable:

- Previously irradiated lesions

- Lymphangitic spread

- Ascites

- Blastic bone lesions

- Pleural effusions

- No rapidly progressive disease for which hormonal therapy is not indicated

- No massive visceral disease (i.e., more than one third of any organ)

- No brain metastases

- Hormone receptor status:

- Estrogen receptor positive or progesterone receptor positive, defined by 1 of
the following:

- At least 10 femtomoles H3-estrogen or at least 20 femtomoles

- H3 progesterone binding per mg of cytosol protein by DCC or sucrose density
method

- At least 0.10 femtomoles H3-estrogen or at least 0.20 femtomoles

- H3-progesterone binding per mg of DNA by IF/EIA technique

- Positive immunohistochemistry noted on pathology report

- Unknown receptor status eligible provided:

- Disease-free interval of at least 2 years since adjuvant therapy or initial
surgery (if no adjuvant therapy), including most recently treated tumor in
bilateral breast cancer if status unknown in one primary tumor

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Postmenopausal by 1 of the following:

- Natural menopause and more than 1 year since last menstrual period (LMP)

- Radiation-induced oophorectomy and more than 1 year since LMP

- Chemotherapy induced menopause if:

- At least 1 year since LMP (+ 1 year post-tamoxifen)

- Serum FSH and LH and plasma estradiol levels in postmenopausal range

- LHRH-induced amenorrhea

- Surgical castration

- Patients under age 56 with prior hysterectomy and 1 or both ovaries intact
or tamoxifen-induced amenorrhea with at least 12 months since prior
tamoxifen must have postmenopausal serum FSH and LH and plasma estradiol
concentrations

Performance status:

- ECOG (WHO) 0-2

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT/SGPT less than 2.5 times ULN (less than 5 times ULN with liver metastases)

Renal:

- Creatinine less than 1.5 times ULN

Cardiovascular:

- No deep venous thrombosis

Other:

- No mental incapacitation

- No severe concurrent disease

- No prior or concurrent malignancy except curatively treated carcinoma in situ of the
cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since chemotherapy for metastatic disease and recovered

- No more than 1 prior chemotherapy regimen for metastatic disease

- Prior adjuvant chemotherapy allowed if disease free for at least 6 months

- No concurrent chemotherapy

Endocrine therapy:

- No prior hormonal therapy for advanced disease (e.g., tamoxifen or LHRH agonists)

- Prior adjuvant tamoxifen allowed if disease free for at least 6 months

- No other concurrent hormonal therapy, including steroids

Radiotherapy:

- Recovered from toxic effects of prior radiotherapy

- Concurrent palliative radiotherapy, including whole brain irradiation, allowed

Surgery:

- See Disease Characteristics

- No prior ovariectomy for advanced disease

Other:

- No other concurrent investigational drugs

- Concurrent bisphosphonates allowed if short term (7 days) for hypercalcemia due to
suspect tumor flare or if on prior bisphosphonates with bidimensionally measurable
extraosseous lesion



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: tamoxifen citrate

Drug: exemestane

Secondary ID(s)

PHARMACIA-EORTC-10951

EORTC-10951

Source(s) of Monetary Support

Please refer to primary and secondary sponsors