Breast NeoplasmsPhase 2NCT00243503
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
A Phase 2 study testing SU011248/Trastuzumab in people with Breast Neoplasms, run by Pfizer at 27 sites in 5 countries.
Trial summary
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- SU011248/Trastuzumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 27 sitesin 5 countries
- Study dates
- Feb 2006to Jul 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
- HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
- Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
Who cannot join
- Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
- Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
- Prior treatment on a SU11248 clinical trial.
- Uncontrolled brain metastases.
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
United States16 sites
Pfizer Investigational Site
Corinth, Mississippi, 38834
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Harvey, Illinois, 60426
Pfizer Investigational Site
Lafayette, Louisiana, 70503
Pfizer Investigational Site
Las Vegas, Nevada, 89135
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
Munster, Indiana, 46321
Pfizer Investigational Site
New Iberia, Louisiana, 70563
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Newark, Delaware, 19718-6001
Pfizer Investigational Site
Southaven, Mississippi, 38671
Pfizer Investigational Site
Tinley Park, Illinois, 60477
Pfizer Investigational Site
Wilmington, Delaware, 19899
Canada3 sites
Pfizer Investigational Site
Greenfield Park, Quebec, J4V 2H1
Pfizer Investigational Site
Montreal, Quebec, H3G 1A4
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
France3 sites
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Lyon, 69373
Pfizer Investigational Site
Saint-Cloud, 92210
Spain3 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08003
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Valencia, Valencia, 46010
Belgium2 sites
Pfizer Investigational Site
Ottignies, 1340
Pfizer Investigational Site
Wilrijk, 2610
About this study
Official title: A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
- Conditions
- Breast Neoplasms
- Being tested
- SU011248/Trastuzumab
- Keywords
- Breast Cancer Metastatic
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU011248/TrastuzumabDrug
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: SU011248/Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Overall Confirmed Objective Disease Response
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
Measured: From start of treatment through 18 months
Secondary outcomes (11)
Duration of Response (DR)
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.
Measured: From start of treatment through 18 months
Percentage of Participants With Clinical Benefit
Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.
Measured: From start of treatment through 18 months
Progression Free Survival (PFS)
Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.
Measured: From start of treatment through 18 months
Time to Progression (TTP)
Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.
Measured: From start of treatment through 18 months
Overall Survival (OS)
Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.
Measured: From start of study treatment until death or 2 years from first study treatment
Probability of Survival at One Year
One- year survival probability was estimated using the Kaplan-Meier method.
Measured: From start of study treatment until death or 2 years from first study treatment
EORTC QLQ-C30
EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
Measured: From start of treatment through 18 months
EORTC QLQ (BR23)
BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Measured: From start of treatment through 18 months
Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Measured: Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Measured: Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Measured: Predose on Day 1 of Cycle 3 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startFeb 2006
- Primary completionApr 2009
- Study completionJul 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243503
- Sponsor's protocol ID
- A6181067
- Status last verified
- Jul 2011
- First submitted
- 20 Oct 2005
- Last updated
- 22 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.
PubMed 24606768
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00243503
- Acronym / sponsor ID
- A6181067
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 24 Oct 2005 (estimated)
- Results
- Posted 19 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: SU011248/Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
- HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
- Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
Key exclusion criteria (4 listed)
- Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
- Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
- Prior treatment on a SU11248 clinical trial.
- Uncontrolled brain metastases.
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 |
|---|---|---|
| SU011248/TrastuzumabSU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol. | Drug | A |
Primary outcome
Percentage of Participants With Overall Confirmed Objective Disease Response
Time frame: From start of treatment through 18 months
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
11 secondary outcomes
Duration of Response (DR)
Time frame: From start of treatment through 18 months
Percentage of Participants With Clinical Benefit
Time frame: From start of treatment through 18 months
Progression Free Survival (PFS)
Time frame: From start of treatment through 18 months
Time to Progression (TTP)
Time frame: From start of treatment through 18 months
Overall Survival (OS)
Time frame: From start of study treatment until death or 2 years from first study treatment
Probability of Survival at One Year
Time frame: From start of study treatment until death or 2 years from first study treatment
EORTC QLQ-C30
Time frame: From start of treatment through 18 months
EORTC QLQ (BR23)
Time frame: From start of treatment through 18 months
Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib
Time frame: Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Time frame: Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Time frame: Predose on Day 1 of Cycle 3 and 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24606768Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SU011248/Trastuzumab in people with Breast Neoplasms, run by Pfizer at 27 sites in 5 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 3 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 22 Jul 2011. 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, Canada, France, Spain, Belgium. 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 19 May 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?
Percentage of Participants With Overall Confirmed Objective Disease Response (time frame: From start of treatment through 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243503, which also lists 1 linked publication.
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 22 Jul 2011.