Breast NeoplasmsPhase 3NCT00267553
Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs 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 35 sites in 4 countries.
Trial summary
Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase… 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
- How many people
- 200 participants
- Where
- 35 sitesin 4 countries
- Study dates
- Nov 2005to Jun 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
- To be eligible to receive continued treatment, subjects must remain eligible to receive study drug at the time of their last Biomed 777-CLP-29 visit
- To continue on survival follow-up, subjects must be in survival follow-up in study Biomed 777-CLP-29
- Written informed consent obtained for subjects who continue study drug treatment
Who cannot join
- Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason
- Subjects for whom the investigator considers study participation is no longer in the best interest of those subjects.
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
Russia17 sites
Study site
Arkhangelsk
Study site
Kazan'
Study site
Krasnodar
Study site
Leningrad Region
Study site
Lipetsk
Study site
Moscow
Study site
Murmansk
Study site
Nizhny Novgorod
Study site
Novosibirsk
Study site
Obninsk
Study site
Ryazan
Study site
Saint Petersburg
Study site
Samara
Study site
Stavropol
Study site
Tomsk
Study site
Velikiy Novgorod
Study site
Voronezh
Ukraine9 sites
Study site
Dnipro
Study site
Donetsk
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kiev
Study site
Kryvyi Rih
Study site
Lviv
Study site
Odesa
Study site
Uzhhorod
United States6 sites
Study site
Greenbrae, California
Study site
Houston, Texas
Study site
Kansas City, Missouri
Study site
Lacey, Washington
Study site
Norfolk, Virginia
Study site
Saint Joseph, Michigan
Canada3 sites
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Thunder Bay, Ontario
About this study
Official title: Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.
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 survival time for subjects with advanced breast cancer.
- Conditions
- Breast Neoplasms, Neoplasms, Hormone-Dependent
- Being tested
- Atamestane, toremifene, letrozole
- Keywords
- 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, Stage IV 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
What is being measured
The primary outcome is the main question the study is designed to answer.
In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm
Secondary outcomes (1)
In conjunction with the data from Biomed 777-CLP-29, obtain safety, survival and time to treatment failure (TTF) data for both arms in this continuation study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startNov 2005
- Study completionJun 2006
Why it stopped: This was a follow-on study to Biomed 777-CLP-029 which 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
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Langecker, MD, PhD, Study director, Intarcia Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267553
- Sponsor's protocol ID
- Biomed 777-CLP-32
- Status last verified
- Sep 2007
- First submitted
- 20 Dec 2005
- Last updated
- 10 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00267553
- Acronym / sponsor ID
- Biomed 777-CLP-32
- Conditions
- Breast Neoplasms, Neoplasms, Hormone-Dependent
- Keywords
- Atamestane, Breast neoplasms, Combined hormonal therapy, Complete estrogen blockade, Ductal breast carcinoma, Estrogen blocker, Fareston®, Femara®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a follow-on study to Biomed 777-CLP-029 which did not meet superiority endpoint
- Enrolment
- 200 participants
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 21 Dec 2005 (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.
Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.
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 survival time for subjects with advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be eligible to receive continued treatment, subjects must remain eligible to receive study drug at the time of their last Biomed 777-CLP-29 visit
- To continue on survival follow-up, subjects must be in survival follow-up in study Biomed 777-CLP-29
- Written informed consent obtained for subjects who continue study drug treatment
Key exclusion criteria (2 listed)
- Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason
- Subjects for whom the investigator considers study participation is no longer in the best interest of those subjects.
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 | – |
Primary outcome
In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm
1 secondary outcome
In conjunction with the data from Biomed 777-CLP-29, obtain safety, survival and time to treatment failure (TTF) data for both arms in this continuation study.
Results and safety
The study was stopped early (reason given: This was a follow-on study to Biomed 777-CLP-029 which did not meet superiority endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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.
Peter Langecker, MD, PhD study director
Intarcia Therapeutics
35 sites in 4 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 35 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 3 inclusion and 2 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 10 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Russia, Ukraine, United States, 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 was stopped early (reason given: This was a follow-on study to Biomed 777-CLP-029 which 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?
In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm. 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 10 Sep 2007.