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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002777




Registration number
NCT00002777
Ethics application status
Date submitted
1/11/1999
Date registered
11/04/2003
Date last updated
2/07/2012

Titles & IDs
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
Secondary ID [1] 0 0
EORTC-10951
Secondary ID [2] 0 0
EORTC-10951
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
342
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Bankstown - Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
NSW 2200 - Bankstown
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels (Bruxelles)
Country [3] 0 0
Belgium
State/province [3] 0 0
Haine Saint Paul
Country [4] 0 0
Belgium
State/province [4] 0 0
La Louviere
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Namur
Country [7] 0 0
Belgium
State/province [7] 0 0
Wilrijk
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Caen
Country [10] 0 0
France
State/province [10] 0 0
Clermont-Ferrand
Country [11] 0 0
France
State/province [11] 0 0
Dijon
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Rennes
Country [14] 0 0
France
State/province [14] 0 0
Rouen
Country [15] 0 0
France
State/province [15] 0 0
Saint Cloud
Country [16] 0 0
Malaysia
State/province [16] 0 0
Kuala Lumpur
Country [17] 0 0
Netherlands
State/province [17] 0 0
's-Gravenhage (Den Haag, The Hague)
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amersfont
Country [19] 0 0
Netherlands
State/province [19] 0 0
Amsterdam
Country [20] 0 0
Netherlands
State/province [20] 0 0
Eindhoven
Country [21] 0 0
Netherlands
State/province [21] 0 0
Leiden
Country [22] 0 0
Netherlands
State/province [22] 0 0
Leidschendam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Maastricht
Country [24] 0 0
Netherlands
State/province [24] 0 0
Nijmegen
Country [25] 0 0
Netherlands
State/province [25] 0 0
Purmerend
Country [26] 0 0
Netherlands
State/province [26] 0 0
Roermond
Country [27] 0 0
Netherlands
State/province [27] 0 0
Rotterdam
Country [28] 0 0
Netherlands
State/province [28] 0 0
Sittard
Country [29] 0 0
Netherlands
State/province [29] 0 0
Tilburg
Country [30] 0 0
Netherlands
State/province [30] 0 0
Utrecht
Country [31] 0 0
Netherlands
State/province [31] 0 0
Veldhoven
Country [32] 0 0
Philippines
State/province [32] 0 0
Cebu City
Country [33] 0 0
Poland
State/province [33] 0 0
Gdansk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Moscow
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Saint Petersburg
Country [36] 0 0
Slovenia
State/province [36] 0 0
Ljubljana
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
Thailand
State/province [38] 0 0
Bangkok
Country [39] 0 0
United Kingdom
State/province [39] 0 0
England
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.
Trial website
https://clinicaltrials.gov/study/NCT00002777
Trial related presentations / publications
Paridaens RJ, Dirix LY, Beex LV, Nooij M, Cameron DA, Cufer T, Piccart MJ, Bogaerts J, Therasse P. Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol. 2008 Oct 20;26(30):4883-90. doi: 10.1200/JCO.2007.14.4659. Epub 2008 Sep 15.
Atalay G, Dirix L, Biganzoli L, Beex L, Nooij M, Cameron D, Lohrisch C, Cufer T, Lobelle JP, Mattiaci MR, Piccart M, Paridaens R. The effect of exemestane on serum lipid profile in postmenopausal women with metastatic breast cancer: a companion study to EORTC Trial 10951, 'Randomized phase II study in first line hormonal treatment for metastatic breast cancer with exemestane or tamoxifen in postmenopausal patients'. Ann Oncol. 2004 Feb;15(2):211-7. doi: 10.1093/annonc/mdh064.
Paridaens R, Therasse P, Dirix L, et al.: First line hormonal treatment (HT) for metastatic breast cancer (MBC) with exemestane (E) or tamoxifen (T) in postmenopausal patients (pts): A randomized phase III trial of the EORTC Breast group. [Abstract] J Clin Oncol 22 (Suppl 14): A-515, 6s, 2004.
Paridaens R, Therasse P, Dirix L, et al.: First results of a randomized phase III trial comparing exemestane versus tamoxifen as first-line hormone therapy (HT) for postmenopausal women with metastatic breast cancer (MBC) : EORTC 10951 in collaboration with the exemestane working group and NCIC Clinical Trials Group. [Abstract] Eur J Cancer 2 (Suppl 3): A-241, 126, 2004.
Public notes

Contacts
Principal investigator
Name 0 0
Robert Paridaens, MD, PhD
Address 0 0
University Hospital, Gasthuisberg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00002777