Breast CancerPhase 2NCT01068704
Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
A Phase 2 study testing BMS-690514, Lapatinib and Letrozole in people with Breast Cancer, run by Bristol-Myers Squibb at 8 sites in 4 countries.
Trial summary
The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy 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?
- BMS-690514, Lapatinib and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jun 2010to Dec 2010
- 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
- Documented invasive breast cancer
- Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
- HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
- Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
- ECOG Performance status = 0 or 1
Who cannot join
- Prior hormonal therapy for metastatic disease
- Prior hormonal therapy with letrozole for adjuvant disease
- Symptomatic brain metastases
- Prior treatment with any tyrosine kinase inhibitor
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States4 sites
Texas Oncology-Abilene
Abilene, Texas, 79606
Texas Oncology-Beaumont
Beaumont, Texas, 77702
Us Oncology Central Pharmacy
Fort Worth, Texas, 76177
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
Argentina2 sites
Local Institution
La Rioja, La Rioja Province, 5300
Local Institution
Rosario, Santa Fe Province, S2000DSK
About this study
Official title: An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy
The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy
- Conditions
- Breast Cancer
- Being tested
- BMS-690514, Lapatinib, Letrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-690514Drug
Tablets, Oral, 200 mg, once daily, ~ 12 months depending on response
LapatinibDrug
Tablets, Oral, 1500 mg, once daily, ~ 12 months depending on response
LetrozoleDrug
Tablets, Oral, 2.5 mg, once daily, ~ 12 months depending on response
| Study group | Role | What they receive |
|---|---|---|
| BMS-690514 + Letrozole | Active comparator | Not described Receives: Drug: BMS-690514; Drug: Letrozole |
| Lapatinib + Letrozole | Active comparator | Not described Receives: Drug: Lapatinib; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
Measured: Every 8 weeks according to CT scan
Secondary outcomes (3)
Progression Free Survival: defined as time to disease progression
Measured: Every 8 weeks
Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'
Measured: Every 8 weeks
Frequency and severity of adverse events in all subjects
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
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.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068704
- Sponsor's protocol ID
- CA187-016
- Other IDs
- 2009-016622-13, 2009
- Status last verified
- Sep 2015
- First submitted
- 12 Feb 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy
- ClinicalTrials.gov ID
- NCT01068704
- Acronym / sponsor ID
- CA187-016
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Feb 2010 (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 if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-690514 + Letrozole | Active comparator | Drug: BMS-690514, Drug: Letrozole |
| Lapatinib + Letrozole | Active comparator | Drug: Lapatinib, Drug: Letrozole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented invasive breast cancer
- Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
- HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
- Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
- ECOG Performance status = 0 or 1
Key exclusion criteria (4 listed)
- Prior hormonal therapy for metastatic disease
- Prior hormonal therapy with letrozole for adjuvant disease
- Symptomatic brain metastases
- Prior treatment with any tyrosine kinase inhibitor
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 |
|---|---|---|
| BMS-690514Tablets, Oral, 200 mg, once daily, ~ 12 months depending on response | Drug | BMS-690514 + Letrozole |
| LapatinibTablets, Oral, 1500 mg, once daily, ~ 12 months depending on response | Drug | Lapatinib + Letrozole |
| LetrozoleTablets, Oral, 2.5 mg, once daily, ~ 12 months depending on response | Drug | BMS-690514 + Letrozole, Lapatinib + Letrozole |
Primary outcome
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
Time frame: Every 8 weeks according to CT scan
3 secondary outcomes
Progression Free Survival: defined as time to disease progression
Time frame: Every 8 weeks
Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'
Time frame: Every 8 weeks
Frequency and severity of adverse events in all subjects
Time frame: Every 4 weeks
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 12 Oct 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-690514, Lapatinib and Letrozole in people with Breast Cancer, run by Bristol-Myers Squibb at 8 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 5 inclusion and 4 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Argentina, Mexico, Peru. 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?
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months (time frame: Every 8 weeks according to CT scan). 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 12 Oct 2015.