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Breast CancerPhase 3NCT00002777

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

A Phase 3 study testing exemestane and tamoxifen citrate in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 48 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
exemestane and tamoxifen citrate
How many people
342 participants
Where
48 sitesin 12 countries
Study dates
May 1996to Dec 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

48 sites in 12 countries.

48 sites in 12 countries

Netherlands16 sites

  • Leyenburg Ziekenhuis

    's-Gravenhage (Den Haag, the Hague), 2545 CH

  • Ziekenhuis Eemland de Lichtenberg

    Amersfont, 3016 CP

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Catharina Ziekenhuis

    Eindhoven, 5602 ZA

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Medisch Centrum Haaglanden Locatle Antoniushove

    Leidschendam, 2262 BA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • Waterlandziekenhuis

    Purmerend, 1440 AG

  • Saint Laurentius Ziekenhuis

    Roermond, 6043 CV

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA

  • Maasland Hospital

    Sittard, 6131 BK

  • St. Elisabeth Ziekenhuis

    Tilburg, 5022 GC

  • Diakonessenhuis Utrecht

    Utrecht, 3508 TG

  • Sint Joseph Ziekenhuis

    Veldhoven, 5500 MB DB

Other trials in Netherlands

Belgium8 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

  • Centre Hospitalier Etterbeek Ixelles

    Brussels (Bruxelles), B-1050

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • Centre Hospitalier Universitaire de Tivoli

    La Louvière, 7100

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Clinique Sainte Elisabeth

    Namur, 5000

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

France8 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

    Dijon, 21079

  • Centre Leon Berard

    Lyon, 69373

  • Centre Eugene Marquis

    Rennes, 35064

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

Other trials in France

Australia4 sites

  • Bankstown - Lidcombe Hospital

    Bankstown, NSW 2200

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

Other trials in Australia

United Kingdom4 sites

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Guy's and St. Thomas' Hospitals Trust

    London, England, SE1 9RT

  • South Tees Hospitals NHS Trust

    Middlesbrough, Cleveland, England, TS4 3BW

  • Weston Park Hospital

    Sheffield, England, S1O 2SJ

Other trials in United Kingdom

Russia2 sites

  • Russian Academy of Medical Sciences Cancer Research Center

    Moscow, 115478

  • Petrov Research Institute of Oncology

    Saint Petersburg, 197758

Other trials in Russia

Malaysia1 site

  • University of Malaysia Medical Center

    Kuala Lumpur, 59100

Other trials in Malaysia

Philippines1 site

  • Chong Hua Medical Arts Center

    Cebu City, 6000

Other trials in Philippines

Poland1 site

  • Medical University of Gdansk

    Gdansk, 80-211

Other trials in Poland

Slovenia1 site

  • Institute of Oncology, Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

Taiwan1 site

  • Tri-Service General Hospital

    Taipei, NEIHU- 114

Other trials in Taiwan

Thailand1 site

  • Siriraj Hospital

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS

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.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of exemestane vs tamoxifen, in terms of progression-free survival, in postmenopausal women with locally recurrent or metastatic breast cancer.
  • Determine the safety profile of exemestane in these patients.
  • Compare the overall survival of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. (Phase II of this study closed as of 6/14/00). Patients are stratified by participating center, prior adjuvant tamoxifen (yes vs no), prior chemotherapy for metastatic disease (yes vs no), and dominant site of metastasis (visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only).

Patients are randomized to receive either oral exemestane or oral tamoxifen daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 18 months and then at least every 6 months thereafter.

PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study within 4.7 years.

Conditions
Breast Cancer
Being tested
exemestane, tamoxifen citrate
Keywords
stage IV breast cancer, recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exemestaneDrug

  • tamoxifen citrateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2003 (estimated)
  2. Study startMay 1996
  3. Primary completionDec 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
342 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002777
Sponsor's protocol ID
EORTC-10951
Other IDs
EORTC-10951, PHARMACIA-EORTC-10951
Status last verified
Jun 2012
First submitted
1 Nov 1999
Last updated
2 Jul 2012
Results posted
No

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.

    PubMed 18794551

  • 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.

    PubMed 14760111

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exemestane and tamoxifen citrate in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 48 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Netherlands, Belgium, France, Australia, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002777, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.

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