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Breast NeoplasmsPhase 3NCT00044291

Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

A Phase 3 study testing atamestane, toremifene and letrozole in people with Breast Neoplasms and Neoplasms, Hormone-dependent, run by Intarcia Therapeutics at 63 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
atamestane, toremifene and letrozole
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
865 participants
Where
63 sitesin 4 countries
Study dates
Jun 2002to Jan 2006
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

Who may be able to join

  • Women age 18 years or older
  • Pathological or histological confirmation of breast cancer at initial diagnosis or at the time of metastases
  • ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher
  • Predicted life expectancy of 12 weeks or more
  • Postmenopausal endocrine status. LH/FSH levels in the postmenopausal range in women whose menopause occurred less than 5 years ago
  • Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease
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  • At least one tumor localization measurable in 2 dimensions (one diameter at least 2 cm for soft tissue/visceral disease assessed by CT/MRI scan or conventional X-ray technique, one diameter at least 1 cm for bone lesions assessed by conventional X-ray techniques)
  • Estrogen receptor and/or progesterone receptor positive (by laboratory/institutional standard) at the time of initial diagnosis or determined during subsequent biopsy/surgery of metastases
  • Written informed consent obtained

Who cannot join

  • Prior hormonal therapy to treat locally recurrent, locally advanced or metastatic disease
  • Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs within 12 months prior to enrollment
  • Progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis)
  • Life-threatening locally recurrent, locally advanced or metastatic disease or disease requiring chemotherapeutic intervention (such as inflammatory breast cancer)
  • History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases
  • Other active malignancy (except basal cell carcinoma of the skin or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years
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  • Renal insufficiency (serum creatinine > 2.0 mg/dL)
  • Aspartate aminotransferase, alanine aminotransferase or serum bilirubin levels more than 2.5 times upper limit of normal
  • Hemoglobin <9 g/dL
  • Platelet count of less than 100,000 platelets per mm3
  • Total white blood cell count of less than 2,000 cells per mm3
  • Premenopausal endocrine status; pregnant or lactating females
  • Usage of an investigational drug within the thirty (30) days prior to enrollment; or the planned usage of an investigational drug other than the study medication during the course of the current study
  • Contraindication to use of toremifene, atamestane, letrozole or any of the inactive components of their formulations
  • Prior enrollment in this study

Trial locations and contacts

63 sites in 4 countries.

63 sites in 4 countries

Russia27 sites

  • Arkhangelsk Regional Oncology Center, Department of Chemotherapy

    Arkhangelsk, 163045

  • Tatarstan Republican Clinical Oncology Center

    Kazan', 420029

  • Krasnodar Regional Clinical Oncology Center, Chemotherapy Department

    Krasnodar, 350040

  • Lipetsk Regional Oncology Center, Department of General Oncology

    Lipetsk, 398005

  • Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors

    Moscow, 115478

  • Blokhin Cancer Research Center, Department of Chemotherapy

    Moscow, 115478

  • Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy

    Moscow, 115478

  • Blokhin Cancer Research Center, Department of New Antitumor Drug Research

    Moscow, 115478

  • Hertzen Research Institute of Oncology, Department of Chemotherapy

    Moscow, 125284

  • Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy

    Moscow, 129128

  • Moscow City Hospital #40, Department of Chemotherapy

    Moscow, 129301

  • Moscow City Oncology Hospital #62

    Moscow, 143423

  • Murmansk Regional Oncology Center

    Murmansk, 183047

  • Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department

    Novosibirsk, 630047

  • Medical Radiological Research Center

    Obninsk, 249036

  • Ryazan Regional Clinical Oncology Center

    Ryazan, 390046

  • Leningrad Regional Oncology Center

    Saint Petersburg, 188663

  • St. Petersburg City Oncology Center

    Saint Petersburg, 197022

  • Laboratory of Thoracic Oncology, St. Petersburg Pavlov State Medical University, Research Institute of Pulmonology

    Saint Petersburg, 197089

  • Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation

    Saint Petersburg, 197758

  • Petrov Research Institute of Oncology, Department of Breast Cancer

    Saint Petersburg, 197758

  • Petrov Research Institute of Oncology, Department of Chemotherapy

    Saint Petersburg, 197758

  • Samara Regional Oncology Center, Department of Chemotherapy

    Samara, 443066

  • Stavropol Regional Oncology Center, Department of Chemotherapy

    Stavropol, 355018

  • Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy

    Tomsk, 634028

  • V. Novgorod Regional Oncology Center, Department of Chemotherapy

    V. Novgorod, 173016

  • Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center

    Voronezh, 394000

Other trials in Russia

United States17 sites

  • Maryland Hematology/Oncology Associates

    Baltimore, Maryland, 21236

  • Hematology Oncology Consultants, Inc.

    Columbus, Ohio, 43235

  • Great Falls Clinic-Oncology West

    Great Falls, Montana, 59405

  • California Cancer Care, Inc.

    Greenbrae, California, 94904-2007

  • Oncology Consultants

    Houston, Texas, 77024

  • Kansas City Oncology and Hematology Group

    Kansas City, Missouri, 64131

  • First Dynamic Healthcare Services, Inc.

    Killeen, Texas, 76710

  • Midwest Internal Medicine, PLLC

    Lake Havasu City, Arizona, 86403

  • Cache Valley Cancer Treatment & Research Clinic

    Logan, Utah, 84341

  • Innovative Medical Research of South Florida Inc.

    Miami Shores, Florida, 33138

  • Slocum-Dickson Medical Group

    New Hartford, New York, 13413

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Western Washington Oncology Inc., P.S.

    Olympia, Washington, 98502

  • Oncology Care Associates, PLLC

    Saint Joseph, Michigan, 49085

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Georgia Cancer Specialists

    Tucker, Georgia, 30084

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

Other trials in United States

Ukraine15 sites

  • Cherkassy Regional Oncology Center, Chemotherapy Department

    Cherkassy, 18009

  • Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4

    Dnipro, 49102

  • Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department

    Donetsk, 83092

  • Ivano-Frankovsk State Medical Academy; Oncology Department Clinical Facility: Ivano-Frankovsk Regional Oncology Center

    Ivano-Frankivsk, 76000

  • Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department

    Kharkiv, 61024

  • Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department

    Kharkiv, 61070

  • Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department

    Kiev, 01021

  • Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors

    Kiev, 03022

  • Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department

    Kiev, 03115

  • National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department

    Kiev, 03115

  • Krivoy Rog City Oncology Center

    Kryvyi Rih, 50048

  • Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department

    Lviv, 79031

  • Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department

    Odesa, 65055

  • Uzhgorod National University Oncology Course of Surgery Department of Postgraduate Education Faculty Clinical Facility: Zakarpatye Regional Oncology Center

    Uzhhorod, 88000

  • Zaporozhye Statue Institute of Postgraduate Training. Oncology Department; Clinical Facility: Zaporozhye Regional Oncology Center

    Zaporizhzhya, 69104

Other trials in Ukraine

Canada4 sites

  • McGill University, Department of Oncology

    Montreal, Quebec, H2W1S6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K 1H 1C4

  • Northwestern Ontario Regional Cancer Centre

    Thunder Bay, Ontario, P7A7T1

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.

Read the detailed description

Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens and androgenic precursors in the body. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve maximal suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combination therapy will lengthen the time to disease progression and the rate of objective response compared to single agent aromatase inhibitor therapy with letrozole.

Being tested
atamestane, toremifene, letrozole, aromatase inhibition, hormone therapy
Keywords
Atamestane, Toremifene, Letrozole, Aromatase inhibitor, Receptor-positive, First line therapy, Estrogen blocker, Metastatic breast cancer, Locally advanced breast cancer, Locally recurrent breast cancer, stage IV breast cancer, ductal breast carcinoma, lobular breast carcinoma, stage IIIA breast cancer, stage IIIB breast cancer, recurrent breast cancer
Medical subject headings
Breast Neoplasms, Neoplasms, Hormone-Dependent, Carcinoma, Ductal, Breast, Carcinoma, Lobular

What participants receive

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

  • atamestaneDrug

  • toremifeneDrug

  • letrozoleDrug

  • aromatase inhibitionDrug

  • hormone therapyProcedure or surgery

  • endocrine therapyProcedure or surgery

  • antiestrogen therapyProcedure or surgery

Study groups in NCT00044291
Study groupRoleWhat they receive
Atamestane + toremifeneExperimentalNot described
Receives: Drug: atamestane; Drug: toremifene; Drug: aromatase inhibition; Procedure: hormone therapy; Procedure: endocrine therapy; Procedure: antiestrogen therapy
Letrozole + placeboActive comparatorNot described
Receives: Drug: letrozole; Drug: aromatase inhibition; Procedure: hormone therapy; Procedure: endocrine therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to tumor progression

    Measured: time from randomization to first occurrence of tumor progression, assessed at week 12 and every subsequent 12 weeks for patients continuing in the study for up to approximately 36 months

Timeline

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

  1. First posted27 Aug 2002 (estimated)
  2. Study startJun 2002
  3. Primary completionJan 2006
  4. Study completionJan 2006

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
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
865 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00044291
Sponsor's protocol ID
Biomed 777-CLP-29
Status last verified
Jul 2015
First submitted
23 Aug 2002
Last updated
31 Jul 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing atamestane, toremifene and letrozole in people with Breast Neoplasms and Neoplasms, Hormone-dependent, run by Intarcia Therapeutics at 63 sites in 4 countries.

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Russia, United States, Ukraine, Canada. 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.

What does the primary outcome measure?

Time to tumor progression (time frame: time from randomization to first occurrence of tumor progression, assessed at week 12 and every subsequent 12 weeks for patients continuing in the study for up to approximately 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00044291.

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 31 Jul 2015.

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