MedDataX Logo

Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

NCT ID: NCT00246571

Last Updated: 2012-07-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

SU011248

Intervention Type DRUG

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.

B

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type DRUG

The 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SU011248

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.

Intervention Type DRUG

Chemotherapy

The 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sutent, sunitinib malate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* More than two chemotherapy regimens for advanced disease
* Uncontrolled/symptomatic spread of cancer to the brain
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Corona, California, United States

Site Status

Pfizer Investigational Site

Fullerton, California, United States

Site Status

Pfizer Investigational Site

Glendora, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Mission Hills, California, United States

Site Status

Pfizer Investigational Site

Northridge, California, United States

Site Status

Pfizer Investigational Site

Palm Springs, California, United States

Site Status

Pfizer Investigational Site

Pasadena, California, United States

Site Status

Pfizer Investigational Site

Pomona, California, United States

Site Status

Pfizer Investigational Site

Rancho Cucamonga, California, United States

Site Status

Pfizer Investigational Site

Santa Monica, California, United States

Site Status

Pfizer Investigational Site

Valencia, California, United States

Site Status

Pfizer Investigational Site

West Covina, California, United States

Site Status

Pfizer Investigational Site

Aurora, Colorado, United States

Site Status

Pfizer Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Pfizer Investigational Site

Boca Raton, Florida, United States

Site Status

Pfizer Investigational Site

Gainesville, Florida, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Decatur, Georgia, United States

Site Status

Pfizer Investigational Site

Macon, Georgia, United States

Site Status

Pfizer Investigational Site

Marietta, Georgia, United States

Site Status

Pfizer Investigational Site

Tucker, Georgia, United States

Site Status

Pfizer Investigational Site

Zion, Illinois, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Bloomfield Hills, Michigan, United States

Site Status

Pfizer Investigational Site

Brownstown, Michigan, United States

Site Status

Pfizer Investigational Site

Dearborn, Michigan, United States

Site Status

Pfizer Investigational Site

Detroit, Michigan, United States

Site Status

Pfizer Investigational Site

West Bloomfield, Michigan, United States

Site Status

Pfizer Investigational Site

Biloxi, Mississippi, United States

Site Status

Pfizer Investigational Site

Clarkson Valley, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

Midland Park, New Jersey, United States

Site Status

Pfizer Investigational Site

Morristown, New Jersey, United States

Site Status

Pfizer Investigational Site

Paramus, New Jersey, United States

Site Status

Pfizer Investigational Site

Pompton Plains, New Jersey, United States

Site Status

Pfizer Investigational Site

Ridgewood, New Jersey, United States

Site Status

Pfizer Investigational Site

Summit, New Jersey, United States

Site Status

Pfizer Investigational Site

Westwood, New Jersey, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

The Bronx, New York, United States

Site Status

Pfizer Investigational Site

Clinton, North Carolina, United States

Site Status

Pfizer Investigational Site

Goldsboro, North Carolina, United States

Site Status

Pfizer Investigational Site

Wilson, North Carolina, United States

Site Status

Pfizer Investigational Site

Del City, Oklahoma, United States

Site Status

Pfizer Investigational Site

Greensburg, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Hershey, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Wexford, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Fort Worth, Texas, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Plano, Texas, United States

Site Status

Pfizer Investigational Site

Plano, Texas, United States

Site Status

Pfizer Investigational Site

Richardson, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Atonio, Texas, United States

Site Status

Pfizer Investigational Site

Tyler, Texas, United States

Site Status

Pfizer Investigational Site

Federal Way, Washington, United States

Site Status

Pfizer Investigational Site

Lakewood, Washington, United States

Site Status

Pfizer Investigational Site

Puyallup, Washington, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Tacoma, Washington, United States

Site Status

Pfizer Investigational Site

Sofia, Bulgaria, Bulgaria

Site Status

Pfizer Investigational Site

Sofia, , Bulgaria

Site Status

Pfizer Investigational Site

Sofia, , Bulgaria

Site Status

Pfizer Investigational Site

Stara Zagora, , Bulgaria

Site Status

Pfizer Investigational Site

Varna, , Bulgaria

Site Status

Pfizer Investigational Site

Edmonton, Alberta, Canada

Site Status

Pfizer Investigational Site

Toronto, Ontario, Canada

Site Status

Pfizer Investigational Site

Brno, Ceska Republika, Czechia

Site Status

Pfizer Investigational Site

Prague, Ceska Republika, Czechia

Site Status

Pfizer Investigational Site

Brno, , Czechia

Site Status

Pfizer Investigational Site

Prague, , Czechia

Site Status

Pfizer Investigational Site

Besançon, , France

Site Status

Pfizer Investigational Site

Besançon, , France

Site Status

Pfizer Investigational Site

Nantes, , France

Site Status

Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Aviano (PN), , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Prato, FI, , Italy

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Girona, Gerona, Spain

Site Status

Pfizer Investigational Site

Lleida, Lleida, Spain

Site Status

Pfizer Investigational Site

Málaga, Malaga, Spain

Site Status

Pfizer Investigational Site

Seville, Sevilla, Spain

Site Status

Pfizer Investigational Site

Adana, Balcali, Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Ankara, Besevler, Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Istanbul, Pendik, Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Ankara, Sihhiye, Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

Pfizer Investigational Site

Kyiv, , Ukraine

Site Status

Pfizer Investigational Site

Odesa, , Ukraine

Site Status

Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Pfizer Investigational Site

Oxfordshire, , United Kingdom

Site Status

Pfizer Investigational Site

Southampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Bulgaria Canada Czechia France Germany Hungary Italy Spain Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23958375 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181077&StudyName=Study%20Of%20SU011248%20Versus%20Chemotherapy%20For%20Patients%20With%20Previously%20Treated%20Triple%20Receptor%20Negative%20Breast%20Cancer

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6181077

Identifier Type: -

Identifier Source: org_study_id