Breast CancerPhase 2NCT00166543
Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer
A Phase 2 study testing TAS-108 in people with Breast Cancer, run by SRI International at 1 site in United States.
Trial summary
This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer. 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?
- TAS-108
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jan 2008
- Phase
- Phase 2
- 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
- Postmenopausal females
- Histologically or cytologically confirmed diagnosis of breast carcinoma
- Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
- Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
- Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
- Performance status of greater than or equal to 2 on the Zubrod scale
Show all 14Show fewer
- Predicted life expectancy of greater than or equal to 12 weeks
- Must give written informed consent
- Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Absolute granulocyte count of greater than 1,500/meqL, platelet count greater than 75,000/meqL, and a hemoglobin of greater than 10 g/dL
- Adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
- Transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
- The patient has recovered from all previous anti-cancer treatment related to toxicities to at least Grade 1.
- All previous investigational drugs must be stopped at least four weeks before commencement of treatment with TAS-108.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Double-Blinded Efficacy and Safety Study of Three Doses of TAS-108 Administered Orally in Postmenopausal Patients With Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Cancer Following Standard First-Line Endocrine Therapy
This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer.
Read the detailed description
The objective of this study is to investigate the efficacy and safety of TAS-108 administered in postmenopausal patients with locally advanced or locally recurrent inoperable or progressive metastatic breast carcinoma who have previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- TAS-108
- Keywords
- locally advanced breast carcinoma, locally recurrent inoperable breast carcinoma, progressive metastatic breast carcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-108Drug
| Study group | Role | What they receive |
|---|---|---|
| TAS-108 40 mg | Experimental | Not described Receives: Drug: TAS-108 |
| TAS-108 80 mg | Experimental | Not described Receives: Drug: TAS-108 |
| TAS-108 120 mg | Experimental | Not described Receives: Drug: TAS-108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of TAS-108 administered on this schedule
Treatment-emergent adverse events, serious adverse events, bone mineral density
Measured: Up to 4 years and 3 months
To investigate the comparative concentrations of TAS-108 and its metabolites in tumor tissue and blood at steady-state
Measured: Up to 4 years and 3 months
To determine the time to progression of TAS-108 administered on this schedule
Measured: Up to 4 years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJan 2008
- Study completionJan 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- SRI International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- James N. Ingle, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166543
- Sponsor's protocol ID
- 2216-03
- Other IDs
- TAS108-0004
- Status last verified
- Jun 2015
- First submitted
- 12 Sep 2005
- Last updated
- 18 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blinded Efficacy and Safety Study of Three Doses of TAS-108 Administered Orally in Postmenopausal Patients With Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Cancer Following Standard First-Line Endocrine Therapy
- ClinicalTrials.gov ID
- NCT00166543
- Acronym / sponsor ID
- 2216-03
- Conditions
- Breast Cancer
- Keywords
- locally advanced breast carcinoma, locally recurrent inoperable breast carcinoma, progressive metastatic breast carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- SRI InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- May 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Sep 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.
This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer.
Detailed description
The objective of this study is to investigate the efficacy and safety of TAS-108 administered in postmenopausal patients with locally advanced or locally recurrent inoperable or progressive metastatic breast carcinoma who have previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAS-108 40 mg | Experimental | Drug: TAS-108 |
| TAS-108 80 mg | Experimental | Drug: TAS-108 |
| TAS-108 120 mg | Experimental | Drug: TAS-108 |
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)
- Postmenopausal females
- Histologically or cytologically confirmed diagnosis of breast carcinoma
- Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
- Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
- Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TAS-108 | Drug | TAS-108 120 mg, TAS-108 40 mg, TAS-108 80 mg |
Primary outcome
To evaluate the safety of TAS-108 administered on this schedule
Time frame: Up to 4 years and 3 months
Treatment-emergent adverse events, serious adverse events, bone mineral density
To investigate the comparative concentrations of TAS-108 and its metabolites in tumor tissue and blood at steady-state
Time frame: Up to 4 years and 3 months
To determine the time to progression of TAS-108 administered on this schedule
Time frame: Up to 4 years and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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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.
James N. Ingle, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-108 in people with Breast Cancer, run by SRI International 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?
The sponsor lists 14 inclusion and 0 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 18 Aug 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the safety of TAS-108 administered on this schedule (time frame: Up to 4 years and 3 months). The study lists 3 primary outcomes in all. 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 18 Aug 2015.