Breast NeoplasmsPhase 3NCT00097344
The CAT Study: 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 104 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination 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, and whether the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasms, Hormone-Dependent
- What is being tested?
- Atamestane, Toremifene and Letrozole
- Type of treatment
- Surgery or procedure
- How many people
- 842 participants
- Where
- 104 sitesin 5 countries
- Study dates
- Dec 2004to Aug 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
- Postmenopausal women who are to receive their first hormonal treatment for locally recurrent, locally advanced, or metastatic disease, and who would be appropriate candidates for treatment with antiestrogens or aromatase inhibitors.
- Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease.
- Pathological or histological confirmation at primary diagnosis of breast cancer or at the time of diagnosis of advanced disease.
- ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher.
- Predicted life expectancy of 12 weeks or more.
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- Postmenopausal endocrine status. LH/FSH levels in the postmenopausal range in women whose menopause occurred less than 5 years ago.
- At least one tumor localization measurable in 2 dimensions.
- One diameter either at least 2 cm or at least two times the CT/MRI slice/reconstruction thickness for bone/soft tissue/visceral disease assessed by CT/MRI scan (to include spiral CT technique).
- One diameter at least 2 cm for lesions other than bone lesions assessed by conventional X-ray techniques.
- 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 primary diagnosis or determined during subsequent biopsy/surgery of metastases.
- Administration of bisphosphonates in patients with bone metastases is allowed, as long as the drug is started prior to randomization of the patient.
- Written informed consent obtained.
Who cannot join
- Prior hormonal therapy (including oophorectomy or treatment with LH/RH analogs) to treat locally recurrent, locally advanced, or metastatic disease.
- Prior chemotherapy to treat locally recurrent, locally advanced, or metastatic disease.
- Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs with last dose administered within 3 months prior to enrollment.
- Primary diagnosis of disease or progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis).
- Life-threatening disease requiring chemotherapeutic intervention.
- History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases.
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- Other active malignancy (except basal cell carcinoma of the skin, contralateral breast cancer, or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years.
- 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 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 as stated in the investigators brochure or product package insert.
- Patients who are unable to comply with the study requirements or diagnostic procedures.
- Prior enrollment in this study.
Trial locations and contacts
104 sites in 5 countries.
104 sites in 5 countries
United States49 sites
Research Site
Augusta, Georgia, 30901
Research Site
Billings, Montana, 59101
Research Site
Bristol, Tennessee, 37620
Research Site
Cherry Hill, New Jersey, 08003
Research Site
Chesapeake, Virginia, 23320
Research Site
Columbia, South Carolina, 29203
Research Site
Danville, Virginia, 24541
Research Site
Detroit, Michigan, 48076
Research Site
Evansville, Indiana, 47713
Research Site
Flint, Michigan, 48532
Research Site
Fountain Valley, California, 92708
Research Site
Fresh Meadows, New York, 11365
Research Site
Greenbrae, California, 94904
Research Site
Greenwich, Connecticut, 06830
Research Site
Hot Springs, Arkansas, 71913
Research Site
Houston, Texas, 77024
Research Site
Jacksonville, Florida, 32209
Research Site
Kissimmee, Florida, 34741
Research Site
Lacey, Washington, 98503
Research Site
Lenexa, Kansas, 66214
Research Site
Los Angeles, California, 90807
Research Site
Louisville, Kentucky, 40207
Research Site
Memphis, Tennessee, 38120
Research Site
Miami, Florida, 33176
Research Site
Milwaukee, Wisconsin, 53215
Research Site
Mobile, Alabama, 36607
Research Site
New Albany, Indiana, 47150
Research Site
Newark, New Jersey, 07101
Research Site
Norfolk, Virginia, 23502
Research Site
Ocala, Florida, 34474
Research Site
Ogden, Utah, 84403
Research Site
Pasadena, Texas, 77504
Research Site
Pembroke Pines, Florida, 33028
Research Site
Philadelphia, Pennsylvania, 19146
Research Site
Poway, California, 92064
Research Site
Racine, Wisconsin, 53405
Research Site
Reno, Nevada, 89502
Research Site
Rhinelander, Wisconsin, 54501
Research Site
Robbinsdale, Minnesota, 55422
Research Site
Savannah, Georgia, 31405
Research Site
Shreveport, Louisiana, 71105
Research Site
St Louis, Missouri, 63128
Research Site
Tampa, Florida, 33607
Research Site
Towson, Maryland, 21204
Research Site
Tuscon, Arizona, 85704
Research Site
Valhalla, New York, 10595
Research Site
West Reading, Pennsylvania, 19611
Research Site
Wooster, Ohio, 44691
Research Site
Zanesville, Ohio, 43701
Russia25 sites
Research Site
Arkhangelsk, 163045
Research Site
Astrakhan, 414041
Research Site
Chelyabinsk, 454087
Research Site
Engel's, 413115
Research Site
Irkutsk, 664035
Research Site
Kaliningrad, 236040
Research Site
Kaluga, 248007
Research Site
Kazan', 420012
Research site
Krasnodar, 350040
Research Site
Moscow, 119121
Research Site
Moscow, 121356
Research Site
Omsk, 644013
Research Site
Orenburg, 460021
Research Site
Oryol, 302020
Research Site
Perm, 614066
Research Site
Pyatigorsk, 357524
Research Site
Saint Petersburg, 191104
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197758
Research Site
Sochi, 354057
Research Site
Syktyvkar, 167904
Research Site
Tambov, 392013
Research Site
Ufa, 450054
Research Site
Ulyanovsk, 432063
Research Site
Yaroslavl, 150054
Ukraine14 sites
Research Site
Chernihiv, 14029
Research Site
Chernivtsy, 58013
Research Site
Donetsk, 83092
Research Site
Kharkiv, 61024
Research Site
Kherson, 73000
Research Site
Khmelnitsky, 29009
Research Site
Luhansk, 91047
Research Site
Lutsk, 43018
Research Site
Lviv, 79031
Research Site
Mariupol, 87500
Research Site
Odesa, 65025
Research Site
Sumy, 40005
Research Site
Ternopil, 46023
Research Site
Vinnitsa, 21021
Romania9 sites
Research Site
Arad, 310017
Research Site
Brasov, 500366
Research Site
Bucharest, 22115
Research Site
Bucharest, 22328
Research Site
Cluj-Napoca, 400015
Research Site
Oradea, 410032
Research Site
Ploieşti, 100337
Research Site
Târgu Mureş, 540141
Research Site
Timișoara, 300223
Bulgaria7 sites
Research Site
Blagoevgrad, 2700
Research Site
Plovdiv, 4004
Research Site
Shumen, 9700
Research Site
Sofia, 1233
Research Site
Sofia, 1756
Research Site
Stara Zagora, 6003
Research Site
Varna, 9010
About this study
Official title: Phase 3 Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination 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, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.
Read the detailed description
Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women. These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women. Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens from androgenic precursors in the body via the aromatase enzyme. 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 complete suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combined hormonal therapy will lengthen the time to disease progression and the rate of objective response, as compared to single agent therapy with the approved aromatase inhibitor letrozole.
- Conditions
- Breast Neoplasms, Neoplasms, Hormone-Dependent
- Being tested
- Atamestane, Toremifene, Letrozole, Aromatase inhibition, Estrogen receptor blocker
- Keywords
- Aromatase inhibitor, Atamestane, Breast neoplasms, Combined hormonal therapy, Complete estrogen blockade, Ductal breast carcinoma, Estrogen blocker, Fareston®, Femara®, First line therapy, Letrozole, Lobular breast carcinoma, Locally advanced breast cancer, Locally recurrent breast cancer, Maximal estrogen inhibition, Metastatic breast cancer, Neoplasms, Hormone-dependent, Receptor-positive, Stage IIIA breast cancer, Stage IIIB 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
Estrogen receptor blockerDrug
Hormone therapyProcedure or surgery
Endocrine therapyProcedure or surgery
Antiestrogen therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Secondary outcomes (3)
Response rate
Safety
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2004 (estimated)
- Study startDec 2004
- Study completionAug 2006
Why it stopped: Identical study Biomed 777-CLP-029 did not meet superiority endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 842 participants
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edith Perez, MD, Study chair, Professor of Medicine, Mayo Clinic, Jacksonville, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097344
- Sponsor's protocol ID
- Biomed 777-CLP-30
- Status last verified
- Aug 2007
- First submitted
- 22 Nov 2004
- Last updated
- 23 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00097344
- Acronym / sponsor ID
- Biomed 777-CLP-30
- Conditions
- Breast Neoplasms, Neoplasms, Hormone-Dependent
- Keywords
- Aromatase inhibitor, Atamestane, Breast neoplasms, Combined hormonal therapy, Complete estrogen blockade, Ductal breast carcinoma, Estrogen blocker, Fareston®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Identical study Biomed 777-CLP-029 did not meet superiority endpoint
- Enrolment
- 842 participants
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Aug 2006
- First posted
- 23 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination 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, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.
Detailed description
Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women. These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women. Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens from androgenic precursors in the body via the aromatase enzyme. 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 complete suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combined hormonal therapy will lengthen the time to disease progression and the rate of objective response, as compared to single agent therapy with the approved aromatase inhibitor letrozole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women age 18 years or older
- Postmenopausal women who are to receive their first hormonal treatment for locally recurrent, locally advanced, or metastatic disease, and who would be appropriate candidates for treatment with antiestrogens or aromatase inhibitors.
- Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease.
- Pathological or histological confirmation at primary diagnosis of breast cancer or at the time of diagnosis of advanced disease.
- ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher.
Key exclusion criteria (17 listed)
- Prior hormonal therapy (including oophorectomy or treatment with LH/RH analogs) to treat locally recurrent, locally advanced, or metastatic disease.
- Prior chemotherapy to treat locally recurrent, locally advanced, or metastatic disease.
- Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs with last dose administered within 3 months prior to enrollment.
- Primary diagnosis of disease or progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis).
- Life-threatening disease requiring chemotherapeutic intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atamestane | Drug | – |
| Toremifene | Drug | – |
| Letrozole | Drug | – |
| Aromatase inhibition | Drug | – |
| Estrogen receptor blocker | Drug | – |
| Hormone therapy | Procedure or surgery | – |
| Endocrine therapy | Procedure or surgery | – |
| Antiestrogen therapy | Procedure or surgery | – |
Primary outcome
Time to progression
3 secondary outcomes
Response rate
Safety
Overall survival
Results and safety
The study was stopped early (reason given: Identical study Biomed 777-CLP-029 did not meet superiority endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Perez, MD study chair
Professor of Medicine, Mayo Clinic, Jacksonville, Florida
104 sites in 5 countries: see every site and its status.
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 104 sites in 5 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 14 inclusion and 17 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: stopped early, as of the sponsor's last update on 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Russia, Ukraine, Romania, Bulgaria. 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 was stopped early (reason given: Identical study Biomed 777-CLP-029 did not meet superiority endpoint). Results are not available in the source record.
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 progression. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2007.