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

NCT00246571 | Completed Phase 2 Results DMC

• 1 other identifier: A6181077
• Study Type: interventional
• Target: 217
• Locations: 12 countries
• Sites: 113

Brief 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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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").

  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

  Baseline until response or disease progression (up to 3 years from first dose)

• Duration of Response (DR)

  Time from first response to disease progression up to 3 years from first dose

• Survival Probability at 1 Year

  Baseline until death (up to 3 years after first dose of study medication)

• Overall Survival (OS)

  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)

  Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal

Study Arms (2)

A

EXPERIMENTAL

Drug: SU011248

B

ACTIVE COMPARATOR

Drug: Chemotherapy

Interventions

SU011248 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.

Also known as: Sutent, sunitinib malate

A

Chemotherapy 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.

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• More than two chemotherapy regimens for advanced disease
• Uncontrolled/symptomatic spread of cancer to the brain

Sponsors & Collaborators

• Pfizer: lead

Study Sites (113)

Pfizer Investigational Site

Corona, California, 92879, United States

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Fullerton, California, 92835, United States

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Glendora, California, 91741, United States

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Los Angeles, California, 90095-1772, United States

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Los Angeles, California, 90095-7423, United States

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Los Angeles, California, 90095, United States

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Mission Hills, California, 91345, United States

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Northridge, California, 91325, United States

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Palm Springs, California, 92262-4885, United States

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Pasadena, California, 91105, United States

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Pomona, California, 91767, United States

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Rancho Cucamonga, California, 91730, United States

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Santa Monica, California, 90404, United States

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Valencia, California, 91355, United States

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West Covina, California, 91790, United States

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Aurora, Colorado, 80010, United States

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Washington D.C., District of Columbia, 20010, United States

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Boca Raton, Florida, 33428, United States

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Gainesville, Florida, 32605-4391, United States

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Atlanta, Georgia, 30341, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Macon, Georgia, 31217, United States

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Marietta, Georgia, 30060, United States

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Tucker, Georgia, 30084, United States

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Zion, Illinois, 60099, United States

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Indianapolis, Indiana, 46202, United States

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Bloomfield Hills, Michigan, 48302, United States

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Brownstown, Michigan, 48183, United States

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Dearborn, Michigan, 48126, United States

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Detroit, Michigan, 48202, United States

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West Bloomfield, Michigan, 48322, United States

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Biloxi, Mississippi, 39532, United States

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Clarkson Valley, Missouri, 63011, United States

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St Louis, Missouri, 63109, United States

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St Louis, Missouri, 63141, United States

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Midland Park, New Jersey, 07432, United States

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Morristown, New Jersey, 07962, United States

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Paramus, New Jersey, 07652, United States

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Pompton Plains, New Jersey, 07444, United States

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Ridgewood, New Jersey, 07450, United States

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Summit, New Jersey, 07902, United States

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Westwood, New Jersey, 07675, United States

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The Bronx, New York, 10451, United States

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The Bronx, New York, 10461, United States

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Clinton, North Carolina, 28388, United States

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Goldsboro, North Carolina, 27534, United States

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Wilson, North Carolina, 27893, United States

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Del City, Oklahoma, 73115, United States

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Greensburg, Pennsylvania, 15601, United States

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Hershey, Pennsylvania, 17033-0850, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15232-1305, United States

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Wexford, Pennsylvania, 15090, United States

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Memphis, Tennessee, 38104, United States

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Memphis, Tennessee, 38120, United States

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Memphis, Tennessee, 38133, United States

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Dallas, Texas, 75230-2510, United States

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Dallas, Texas, 75230, United States

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Fort Worth, Texas, 76177, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77055, United States

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Plano, Texas, 75075, United States

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Plano, Texas, 75093, United States

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Richardson, Texas, 75080, United States

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San Antonio, Texas, 78207, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78258, United States

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San Atonio, Texas, 78229, United States

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Tyler, Texas, 75702, United States

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Federal Way, Washington, 98003, United States

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Lakewood, Washington, 98499, United States

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Puyallup, Washington, 98372, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Tacoma, Washington, 98405, United States

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Sofia, Bulgaria, 1756, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1527, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Varna, 9000, Bulgaria

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Edmonton, Alberta, T6G 1Z2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Brno, Ceska Republika, 656 91, Czechia

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Prague, Ceska Republika, 180 81, Czechia

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Brno, 656 91, Czechia

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Prague, 180 00, Czechia

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Besançon, 25030, France

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Besançon, 25052, France

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Nantes, 44805, France

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Paris, 75970, France

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Berlin, 10177, Germany

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Budapest, 1082, Hungary

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Budapest, 1122, Hungary

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Aviano (PN), 33081, Italy

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Milan, 20100, Italy

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Prato, FI, 59100, Italy

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Barcelona, Barcelona, 08035, Spain

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Girona, Gerona, 17007, Spain

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Lleida, Lleida, 25198, Spain

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Málaga, Malaga, 29010, Spain

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Seville, Sevilla, 41013, Spain

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Adana, Balcali, 01330, Turkey (Türkiye)

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Ankara, Besevler, 06510, Turkey (Türkiye)

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Istanbul, Pendik, 34890, Turkey (Türkiye)

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Ankara, Sihhiye, 06100, Turkey (Türkiye)

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Dnipropetrovsk, 49102, Ukraine

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Kyiv, 03115, Ukraine

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Odesa, 65055, Ukraine

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Edinburgh, EH4 2XU, United Kingdom

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Oxfordshire, OX3 7LJ, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Related Publications (1)

• 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.

  PMID: 23958375 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sunitinib; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: January 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2011
• Last Updated: July 12, 2012
• Results First Posted: June 27, 2011

Record last verified: 2012-07

Locations

GB (3); CA (2); FR (4); HU (2); TU (4); DE (1); US (77); BU (5); IT (3); ES (5); UA (3); CZ (4)