Breast NeoplasmsPhase 2NCT00246571
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
A Phase 2 study testing SU011248 and Chemotherapy in people with Breast Neoplasms, run by Pfizer at 113 sites in 12 countries.
Trial summary
The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer. 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 and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 113 sitesin 12 countries
- Study dates
- Jan 2006to Jun 2011
- 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
- Recurrent or metastatic breast cancer
- Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
- Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
- Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease
Who cannot join
- More than two chemotherapy regimens for advanced disease
- Uncontrolled/symptomatic spread of cancer to the brain
Trial locations and contacts
113 sites in 12 countries.
113 sites in 12 countries
United States77 sites
Pfizer Investigational Site
Atlanta, Georgia, 30341
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Aurora, Colorado, 80010
Pfizer Investigational Site
Biloxi, Mississippi, 39532
Pfizer Investigational Site
Bloomfield Hills, Michigan, 48302
Pfizer Investigational Site
Boca Raton, Florida, 33428
Pfizer Investigational Site
Brownstown, Michigan, 48183
Pfizer Investigational Site
Clarkson Valley, Missouri, 63011
Pfizer Investigational Site
Clinton, North Carolina, 28388
Pfizer Investigational Site
Corona, California, 92879
Pfizer Investigational Site
Dallas, Texas, 75230-2510
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dearborn, Michigan, 48126
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Del City, Oklahoma, 73115
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Federal Way, Washington, 98003
Pfizer Investigational Site
Fort Worth, Texas, 76177
Pfizer Investigational Site
Fullerton, California, 92835
Pfizer Investigational Site
Gainesville, Florida, 32605-4391
Pfizer Investigational Site
Glendora, California, 91741
Pfizer Investigational Site
Goldsboro, North Carolina, 27534
Pfizer Investigational Site
Greensburg, Pennsylvania, 15601
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77055
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Lakewood, Washington, 98499
Pfizer Investigational Site
Los Angeles, California, 90095-1772
Pfizer Investigational Site
Los Angeles, California, 90095-7423
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Macon, Georgia, 31217
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Memphis, Tennessee, 38133
Pfizer Investigational Site
Midland Park, New Jersey, 07432
Pfizer Investigational Site
Mission Hills, California, 91345
Pfizer Investigational Site
Morristown, New Jersey, 07962
Pfizer Investigational Site
Northridge, California, 91325
Pfizer Investigational Site
Palm Springs, California, 92262-4885
Pfizer Investigational Site
Paramus, New Jersey, 07652
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15232-1305
Pfizer Investigational Site
Plano, Texas, 75075
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Pomona, California, 91767
Pfizer Investigational Site
Pompton Plains, New Jersey, 07444
Pfizer Investigational Site
Puyallup, Washington, 98372
Pfizer Investigational Site
Rancho Cucamonga, California, 91730
Pfizer Investigational Site
Richardson, Texas, 75080
Pfizer Investigational Site
Ridgewood, New Jersey, 07450
Pfizer Investigational Site
San Antonio, Texas, 78207
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78258
Pfizer Investigational Site
San Atonio, Texas, 78229
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98122
Pfizer Investigational Site
St Louis, Missouri, 63109
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Summit, New Jersey, 07902
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
The Bronx, New York, 10451
Pfizer Investigational Site
The Bronx, New York, 10461
Pfizer Investigational Site
Tucker, Georgia, 30084
Pfizer Investigational Site
Tyler, Texas, 75702
Pfizer Investigational Site
Valencia, California, 91355
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
West Bloomfield, Michigan, 48322
Pfizer Investigational Site
West Covina, California, 91790
Pfizer Investigational Site
Westwood, New Jersey, 07675
Pfizer Investigational Site
Wexford, Pennsylvania, 15090
Pfizer Investigational Site
Wilson, North Carolina, 27893
Pfizer Investigational Site
Zion, Illinois, 60099
Bulgaria5 sites
Pfizer Investigational Site
Sofia, Bulgaria, 1756
Pfizer Investigational Site
Sofia, 1233
Pfizer Investigational Site
Sofia, 1527
Pfizer Investigational Site
Stara Zagora, 6000
Pfizer Investigational Site
Varna, 9000
Spain5 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
Girona, Gerona, 17007
Pfizer Investigational Site
Lleida, Lleida, 25198
Pfizer Investigational Site
Málaga, Malaga, 29010
Pfizer Investigational Site
Seville, Sevilla, 41013
Czechia4 sites
Pfizer Investigational Site
Brno, Ceska Republika, 656 91
Pfizer Investigational Site
Brno, 656 91
Pfizer Investigational Site
Prague, Ceska Republika, 180 81
Pfizer Investigational Site
Prague, 180 00
France4 sites
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Besançon, 25052
Pfizer Investigational Site
Nantes, 44805
Pfizer Investigational Site
Paris, 75970
Turkey (Türkiye)4 sites
Pfizer Investigational Site
Adana, Balcali, 01330
Pfizer Investigational Site
Ankara, Besevler, 06510
Pfizer Investigational Site
Ankara, Sihhiye, 06100
Pfizer Investigational Site
Istanbul, Pendik, 34890
Italy3 sites
Pfizer Investigational Site
Aviano (PN), 33081
Pfizer Investigational Site
Milan, 20100
Pfizer Investigational Site
Prato, FI, 59100
Ukraine3 sites
Pfizer Investigational Site
Dnipropetrovsk, 49102
Pfizer Investigational Site
Kyiv, 03115
Pfizer Investigational Site
Odesa, 65055
United Kingdom3 sites
Pfizer Investigational Site
Edinburgh, EH4 2XU
Pfizer Investigational Site
Oxfordshire, OX3 7LJ
Pfizer Investigational Site
Southampton, SO16 6YD
Canada2 sites
Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Hungary2 sites
Pfizer Investigational Site
Budapest, 1082
Pfizer Investigational Site
Budapest, 1122
About this study
Official title: A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer
The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
- Conditions
- Breast Neoplasms
- Being tested
- SU011248, Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU011248Drug
Also called Sutent, sunitinib malate
SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
ChemotherapyDrug
The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.
- Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
- Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
- Docetaxel - 75-100 mg/m2 every 3 weeks
- Paclitaxel - 175-200 mg/m2 every 3 weeks
- Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
- Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: SU011248 |
| B | Active comparator | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Measured: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
Secondary outcomes (19)
Proportion of Participants With Objective Response
Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.
Measured: Baseline until response or disease progression (up to 3 years from first dose)
Duration of Response (DR)
Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Time from first response to disease progression up to 3 years from first dose
Survival Probability at 1 Year
Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.
Measured: Baseline until death (up to 3 years after first dose of study medication)
Overall Survival (OS)
Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Measured: Baseline until death (up to 3 years after first dose of study medication)
Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)
EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Measured: Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
BR23: 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: Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
Measured: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of SU012662 (Metabolite of Sunitinib)
Measured: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of Total Drug (Sunitinib + SU012662)
Measured: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Sunitinib
Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Measured: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Measured: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Measured: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker
Measured: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker
Measured: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)
Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker
Measured: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Placental Growth Factor (sPlGF)
Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker
Measured: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor
Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker
Measured: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Circulating Endothelial Cells (CEC)
Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.
Measured: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Circulating Tumor Cells (CTC)
Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs
Measured: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2010
- Study completionJun 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246571
- Sponsor's protocol ID
- A6181077
- Status last verified
- Jul 2012
- First submitted
- 27 Oct 2005
- Last updated
- 12 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Curigliano G, Pivot X, Cortes J, Elias A, Cesari R, Khosravan R, Collier M, Huang X, Cataruozolo PE, Kern KA, Goldhirsch A. Randomized phase II study of sunitinib versus standard of care for patients with previously treated advanced triple-negative breast cancer. Breast. 2013 Oct;22(5):650-6. doi: 10.1016/j.breast.2013.07.037. Epub 2013 Aug 17.
PubMed 23958375
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer
- ClinicalTrials.gov ID
- NCT00246571
- Acronym / sponsor ID
- A6181077
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Posted 27 Jun 2011
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 compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: SU011248 |
| B | Active comparator | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recurrent or metastatic breast cancer
- Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
- Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
- Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease
Key exclusion criteria (2 listed)
- More than two chemotherapy regimens for advanced disease
- Uncontrolled/symptomatic spread of cancer to the brain
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 |
|---|---|---|
| SU011248Also: Sutent, sunitinib malateSU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit. | Drug | A |
| ChemotherapyThe choice of chemotherapy will be at the discretion of the investigator within the limits outlined below. 1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks 2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles 3. Docetaxel - 75-100 mg/m2 every 3 weeks 4. Paclitaxel - 175-200 mg/m2 every 3 weeks 5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments. 6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248. | Drug | B |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
19 secondary outcomes
Proportion of Participants With Objective Response
Time frame: Baseline until response or disease progression (up to 3 years from first dose)
Duration of Response (DR)
Time frame: Time from first response to disease progression up to 3 years from first dose
Survival Probability at 1 Year
Time frame: Baseline until death (up to 3 years after first dose of study medication)
Overall Survival (OS)
Time frame: Baseline until death (up to 3 years after first dose of study medication)
Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)
Time frame: Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
Time frame: Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
Time frame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of SU012662 (Metabolite of Sunitinib)
Time frame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of Total Drug (Sunitinib + SU012662)
Time frame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Sunitinib
Time frame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
Time frame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
Time frame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
Time frame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
Time frame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)
Time frame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Placental Growth Factor (sPlGF)
Time frame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor
Time frame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Circulating Endothelial Cells (CEC)
Time frame: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Circulating Tumor Cells (CTC)
Time frame: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23958375Curigliano G, Pivot X, Cortes J, Elias A, Cesari R, Khosravan R, Collier M, Huang X, Cataruozolo PE, Kern KA, Goldhirsch A. Randomized phase II study of sunitinib versus standard of care for patients with previously treated advanced triple-negative breast cancer. Breast. 2013 Oct;22(5):650-6. doi: 10.1016/j.breast.2013.07.037. Epub 2013 Aug 17.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Lymphedema, Upper Extremity Lymphedema
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A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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
113 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SU011248 and Chemotherapy in people with Breast Neoplasms, run by Pfizer at 113 sites in 12 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 4 inclusion and 2 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, Bulgaria, Spain, Czechia, France and 7 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 27 Jun 2011). 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?
Progression-Free Survival (PFS) (time frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)). 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 NCT00246571, 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 12 Jul 2012.