Breast CancerPhase 2NCT00371345
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
A Phase 2 study testing Dasatinib and Dasatinib 100 mg in people with Breast Cancer and Metastasis, run by Bristol-Myers Squibb at 23 sites in 7 countries.
Trial summary
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ 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, Metastasis
- What is being tested?
- Dasatinib and Dasatinib 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 23 sitesin 7 countries
- Study dates
- Dec 2006to May 2009
- 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
- females, 18 or older
- recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
- paraffin-embedded tissue block must be available
- measurable disease
- prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
- 0, 1 or 2 chemotherapies in the metastatic setting
- adequate organ function
Who cannot join
- Metastatic disease confined to bone only
- Symptomatic central nervous system (CNS) metastasis
- Concurrent medical condition which may increase the risk of toxicity
- Unable to take oral medication
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
United States7 sites
Dana-Farber Cancer Inst
Boston, Massachusetts, 02115
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 275997305
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, 77030
Mayo Clinic Florida
Jacksonville, Florida, 32224
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Ucsf-Comprehensive Cancer Center
San Francisco, California, 94143
Montefiore Medical Center
The Bronx, New York, 10461
France4 sites
Local Institution
Dijon, 21079
Local Institution
Paris, 75231
Local Institution
Saint-Herblain, 44805
Local Institution
Toulouse, 31052
Argentina3 sites
Local Institution
Buenos Aires, Buenos Aires, 1019
Local Institution
Buenos Aires, Buenos Aires, 1185
Local Institution
Haedo, Buenos Aires, 1684
Peru3 sites
Local Institution
Arequipa, Arequipa
Local Institution
Lima, Lima Province, 34
Local Institution
Lima, Lima Province, LIMA 11
Spain3 sites
Local Institution
Barcelona, 08035
Local Institution
Lleida, 25198
Local Institution
Madrid, 28041
Belgium2 sites
Local Institution
Brussels, 1000
Local Institution
Brussels, 1200
About this study
Official title: Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer
- Conditions
- Breast Cancer, Metastasis
- Being tested
- Dasatinib, Dasatinib 100 mg
- Keywords
- Recurrent, locally-advanced, or metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Recurrence
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, 70 mg, twice daily, as long as the participant benefits (average <6 months)
Dasatinib 100 mgDrug
Also called Sprycel, BMS-354825
Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months)
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID). Receives: Drug: Dasatinib; Drug: Dasatinib 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Objective Response
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.
Measured: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Percentage of Participants With Objective Response
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
Measured: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Best Overall Response
Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.
Measured: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Secondary outcomes (16)
Number of Response-evaluable Participants With Disease Control (DCR)
Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks.
Measured: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Percentage of Response-evaluable Participants With Disease Control (DCR)
Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks.
Measured: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Number of Participants Who Progressed
PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed.
Measured: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Median Progression Free Survival (PFS)
PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed.
Measured: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25
PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed.
Measured: At Weeks 9, 17, and 25
Duration Of Objective Response
Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment.
Measured: the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed
Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Measured: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities
Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death.
Measured: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs
AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Measured: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number Of Participants With Notable Drug-related AEs
Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea.
Measured: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3
Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.
Measured: PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
PK: Plasma Concentration of Dasatinib at Week 7 or Week 9
Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.
Measured: PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR
Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.
Measured: At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR
Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.
Measured: Week 5
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR
VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.
Measured: At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR
VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.
Measured: At Baseline and Week 5 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionMay 2009
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371345
- Sponsor's protocol ID
- CA180-088
- Status last verified
- Apr 2011
- First submitted
- 1 Sep 2006
- Last updated
- 26 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00371345
- Acronym / sponsor ID
- CA180-088
- Conditions
- Breast Cancer, Metastasis
- Keywords
- Recurrent, locally-advanced, or metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 5 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: Dasatinib, Drug: Dasatinib 100 mgParticipants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- females, 18 or older
- recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
- paraffin-embedded tissue block must be available
- measurable disease
- prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
Key exclusion criteria (4 listed)
- Metastatic disease confined to bone only
- Symptomatic central nervous system (CNS) metastasis
- Concurrent medical condition which may increase the risk of toxicity
- Unable to take oral medication
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, 70 mg, twice daily, as long as the participant benefits (average <6 months) | Drug | Dasatinib |
| Dasatinib 100 mgAlso: Sprycel, BMS-354825Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months) | Drug | Dasatinib |
Primary outcome
Number of Participants With Objective Response
Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.
Percentage of Participants With Objective Response
Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
Best Overall Response
Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.
16 secondary outcomes
Number of Response-evaluable Participants With Disease Control (DCR)
Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Percentage of Response-evaluable Participants With Disease Control (DCR)
Time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Number of Participants Who Progressed
Time frame: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Median Progression Free Survival (PFS)
Time frame: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25
Time frame: At Weeks 9, 17, and 25
Duration Of Objective Response
Time frame: the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed
Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation
Time frame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities
Time frame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs
Time frame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number Of Participants With Notable Drug-related AEs
Time frame: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3
Time frame: PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
PK: Plasma Concentration of Dasatinib at Week 7 or Week 9
Time frame: PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR
Time frame: At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR
Time frame: Week 5
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR
Time frame: At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR
Time frame: At Baseline and Week 5 of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
- 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
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib and Dasatinib 100 mg in people with Breast Cancer and Metastasis, run by Bristol-Myers Squibb at 23 sites in 7 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 7 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 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Argentina, Peru, Spain and 2 more countries. 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 5 Nov 2010). 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 Objective Response (time frame: From day of first treatment through Week 25 or at time of discontinuation from study treatment.). 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 26 Apr 2011.