Breast CancerPhase 3NCT00010322
Toremifene With or Without Atamestane in Treating Postmenopausal Women With Metastatic Breast Cancer
A Phase 3 study testing atamestane and toremifene in people with Breast Cancer, run by Intarcia Therapeutics at 1 site in United States.
Trial summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight breast cancer by blocking the production of estrogen. It is not yet known if toremifene is more effective with or without atamestane. 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?
- atamestane and toremifene
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to May 2001
- 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 confirmed metastatic breast cancer Bidimensionally measurable disease Lesion at least 2 cm in at least 1 diameter No failure with prior adjuvant antiestrogens within the first 12 months of treatment No progression of disease during therapy with prior aromatase inhibitors or selective estrogen receptor modulators (SERMs) (including SERMs for prevention of osteoporosis) No history of known central nervous system (CNS) metastases No bone metastases as only tumor manifestation Hormone receptor status: Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Postmenopausal Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 WBC at least 2,000/mm3 Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No significant neurological dysfunction including seizures or clinical signs of other significant neurological diseases No other active malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No contraindication to toremifene or its excipients or any of the excipients in atamestane Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No prior hormonal therapy for metastatic disease At least 12 months since prior adjuvant antiestrogens No concurrent SERMs or estrogenic or androgenic hormones No other concurrent aromatase inhibitors Radiotherapy: No concurrent radiotherapy except for palliation for bone metastases Surgery: Not specified Other: No prior enrollment in this study At least 30 days since prior investigational drugs No other concurrent investigational drugs Concurrent bisphosphonates for bone metastases allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight breast cancer by blocking the production of estrogen. It is not yet known if toremifene is more effective with or without atamestane.
PURPOSE: Randomized phase III trial to compare the effectiveness of toremifene with or without atamestane in treating postmenopausal women who have metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Compare the time to progression in postmenopausal women with metastatic breast cancer treated with toremifene with or without atamestane. II. Compare the response rate, overall survival, duration of response, and time to treatment failure in patients treated with these regimens. III. Compare the safety profile of these regimens in this patient population.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral toremifene daily and oral atamestane twice daily. Arm II: Patients receive oral toremifene as in arm I and an oral placebo twice daily. Treatment continues for 12-30 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 594 patients (297 per treatment arm) will be accrued for this study within 18 months.
- Conditions
- Breast Cancer
- Being tested
- atamestane, toremifene
- 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.
atamestaneDrug
toremifeneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2004 (estimated)
- Study startOct 2000
- Primary completionMay 2001
- Study completionMay 2001
Why it stopped: Withdrawn due to change in standard of care - new protocol required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Langecker, MD, PhD, Study chair, Intarcia Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010322
- Sponsor's protocol ID
- CDR0000068480
- Other IDs
- BIOMED-777-CLP-27
- Status last verified
- Mar 2014
- First submitted
- 2 Feb 2001
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Atamestane Plus Toremifene in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00010322
- Acronym / sponsor ID
- CDR0000068480
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn due to change in standard of care - new protocol required
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- May 2001 (actual)
- Study completion
- May 2001 (actual)
- First posted
- 5 May 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.
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Toremifene may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Atamestane may fight breast cancer by blocking the production of estrogen. It is not yet known if toremifene is more effective with or without atamestane.
PURPOSE: Randomized phase III trial to compare the effectiveness of toremifene with or without atamestane in treating postmenopausal women who have metastatic breast cancer.
Detailed description
OBJECTIVES: I. Compare the time to progression in postmenopausal women with metastatic breast cancer treated with toremifene with or without atamestane. II. Compare the response rate, overall survival, duration of response, and time to treatment failure in patients treated with these regimens. III. Compare the safety profile of these regimens in this patient population.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral toremifene daily and oral atamestane twice daily. Arm II: Patients receive oral toremifene as in arm I and an oral placebo twice daily. Treatment continues for 12-30 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 594 patients (297 per treatment arm) will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Withdrawn due to change in standard of care - new protocol required). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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 chair
Intarcia Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atamestane and toremifene in people with Breast Cancer, run by Intarcia Therapeutics at 1 site in United States.
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: stopped early, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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: Withdrawn due to change in standard of care - new protocol required). 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.
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 26 Mar 2014.