Metastatic Breast CancerPhase 2NCT00696072
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
A Phase 2 study testing Dasatinib and Letrozole in people with Metastatic Breast Cancer, run by Bristol-Myers Squibb at 27 sites in United States.
Trial summary
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Dasatinib and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 27 sitesUnited States
- Study dates
- Aug 2008to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
- Has measurable or evaluable-only disease
- Is female, ≥18 yrs of age, post menopausal or surgically sterile
- HER2 negative, HR+, ER+ and/or PgR+ breast cancer
- 0-1 prior chemotherapy regimen for metastatic disease.
- Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
- Prior tamoxifen therapy is allowed
- No AI therapy for >1 year without recurrence
Who cannot join
- Pregnant or breast feeding
- Prior hormonal therapy for metastatic or locally recurrent disease
- >1 chemotherapy regimen for metastatic disease
- Pleural or pericardial effusion
- Serious cardiac condition
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Texas Oncology-Central Austin Cancer Center
Austin, Texas, 78731
Texas Oncology
Bedord, Texas, 76022
Central Indiana Cancer Centers
Carmel, Indiana, 46032
Texas Cancer Center At Medical City
Dallas, Texas, 75230
Texas Oncology
Dallas, Texas, 75231
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80220
El Paso Cancer Treatment Ctr - East
El Paso, Texas, 79915
Willamette Valley Cancer Center
Eugene, Oregon, 97401
Texas Oncology
Fort Worth, Texas, 76104
Texas Oncology
Garland, Texas, 75042
Texas Oncology
Houston, Texas, 77024
Florida Cancer Institute - New Hope
Hudson, Florida, 34667
Dayton Oncology And Hematology
Kettering, Ohio, 45409
Medical Oncology Associates
Kingston, Pennsylvania, 18704
Virginia Oncology Associates
Norfolk, Virginia, 23502
Texas Oncology-Plano East
Plano, Texas, 75075
Northwest Cancer Specialists, Pc
Portland, Oregon, 97213
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, 24153
Cancer Care Centers Of South Texas
San Antonio, Texas, 78217
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, 77479
New York Oncology Hematology, Pc
Troy, New York, 12180
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, 85704
Tyler Cancer Center
Tyler, Texas, 75702
Texas Oncology Cancer Care And Research Center
Waco, Texas, 76712
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
About this study
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
- Conditions
- Metastatic 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.
DasatinibDrug
Also called Sprycel, BMS-354825
Tablets, Oral, 100 mg once daily, up to 2 years
LetrozoleDrug
Also called Femara
Tablets, Oral, 2.5 mg, once daily, up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Dasatinib; Drug: Letrozole |
| A2 | Active comparator | Not described Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.
Measured: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Secondary outcomes (6)
Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression
CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population
PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014.
Measured: Day 1 to Study Completion (approximately 6 years)
Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib
Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population
Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants.
Measured: At 6 months and at 12 months
Median Time to Treatment Failure (TTF) - ITT Population
Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.
Measured: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Measured: First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Oncology Research
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696072
- Sponsor's protocol ID
- CA180-185
- Other IDs
- USOR 06-185
- Status last verified
- May 2016
- First submitted
- 10 Jun 2008
- Last updated
- 13 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
- ClinicalTrials.gov ID
- NCT00696072
- Acronym / sponsor ID
- CA180-185
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- US Oncology Research
- Study start
- Aug 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Posted 11 May 2016
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 find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: Dasatinib, Drug: Letrozole |
| A2 | Active comparator | 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 (8 listed)
- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
- Has measurable or evaluable-only disease
- Is female, ≥18 yrs of age, post menopausal or surgically sterile
- HER2 negative, HR+, ER+ and/or PgR+ breast cancer
- 0-1 prior chemotherapy regimen for metastatic disease.
Key exclusion criteria (5 listed)
- Pregnant or breast feeding
- Prior hormonal therapy for metastatic or locally recurrent disease
- >1 chemotherapy regimen for metastatic disease
- Pleural or pericardial effusion
- Serious cardiac condition
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 |
|---|---|---|
| DasatinibAlso: Sprycel, BMS-354825Tablets, Oral, 100 mg once daily, up to 2 years | Drug | A1 |
| LetrozoleAlso: FemaraTablets, Oral, 2.5 mg, once daily, up to 2 years | Drug | A1, A2 |
Primary outcome
Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.
6 secondary outcomes
Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population
Time frame: Day 1 to Study Completion (approximately 6 years)
Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population
Time frame: At 6 months and at 12 months
Median Time to Treatment Failure (TTF) - ITT Population
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths
Time frame: First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib and Letrozole in people with Metastatic Breast Cancer, run by Bristol-Myers Squibb at 27 sites 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 8 inclusion and 5 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 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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?
Yes. Results are posted in the registry (first posted 11 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population (time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)). 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 13 Jun 2016.