1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy
A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo When Administered in Combination With Chemotherapy for Patients With Locally Advanced or MBC That Has Progressed During or After Bevacizumab Therapy
1 other identifier
interventional
160
1 country
44
Brief Summary
The study is being conducted to compare progression-free survival in patients treated with sorafenib and gemcitabine/capecitabine versus patients treated with placebo and gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed during or following treatment with a bevacizumab-containing regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jun 2007
Typical duration for phase_2 breast-cancer
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
May 16, 2014
CompletedMay 20, 2014
May 1, 2014
3.3 years
June 26, 2007
April 17, 2014
May 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.
Secondary Outcomes (4)
Overall Survival
From the date of randomization to date of death due to any cause, assessed up to 56 months.
Time to Progression
Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.
Overall Response Rate
The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.
Duration of Overall Response
Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.
Study Arms (2)
A (Sorafenib + Gemcitabine or Capecitabine)
ACTIVE COMPARATORSorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
B (Placebo + Gemcitabine or Capecitabine)
PLACEBO COMPARATORPlacebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Interventions
Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle
Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)
Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the breast.
- Measurable or evaluable locally advanced or metastatic disease.
- Age ≥18 years.
- Disease progression during or after treatment with a bevacizumab-containing regimen in the adjuvant or first-line metastatic setting.
- Patients must have discontinued chemotherapy at least 3 weeks prior to randomization.
- No more than one prior chemotherapy regimen for locally advanced or metastatic disease.
- Prior hormonal therapy allowed provided it has been discontinued prior to randomization.
- Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization. Previously radiated area(s) must not be the only site of disease.
- ECOG Performance Status of 0 or 1.
- Adequate bone marrow, liver, and renal function
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and must agree to use adequate contraception prior to study entry, for the duration of study participation and 28 days after the last study drug dosing.
- Patients must be able and willing to sign a written informed consent.
- Patients must be able to swallow and retain oral medication.
You may not qualify if:
- Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER-2) (gene amplification by FISH or 3+ over-expression by immunohistochemistry). Patients with unknown HER-2 status are not eligible.
- Patients with active brain metastases.
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
- Prior use of gemcitabine/capecitabine or sorafenib.
- Evidence or history of bleeding diathesis or coagulopathy.
- Serious, non-healing wound, ulcer, or bone fracture.
- Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.
- Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.
- Clinically significant cardiac disease
- Uncontrolled hypertension
- Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event \> NCI-CTCAE Grade 2 within 4 weeks of randomization.
- Any other hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks of randomization.
- Active clinically serious infection \> NCI-CTCAE Grade 2.
- Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Accelerated Community Oncology Research Networklead
- Amgencollaborator
Study Sites (44)
Providence Cancer Center / Katmai Oncology Group LLC
Anchorage, Alaska, 99508, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Compassionate Cancer Care-Corona
Corona, California, 92879, United States
Compassionate Cancer Care-Fountain Valley
Fountain Valley, California, 92879, United States
California Cancer Care
Greenbrae, California, 94904-2007, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Compassionate Cancer Care-Riverside
Riverside, California, 92501, United States
Sutter Cancer Center
Sacramento, California, 98516, United States
California Pacific Medical Center
San Francisco, California, 94107, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, 94115, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
Hematology Oncology PC / Bennett Cancer Center
Stamford, Connecticut, 06902, United States
Oncology Associates of Bridgeport
Trumbull, Connecticut, 06611, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Pasco Hernando Oncology Associates PA
Brooksville, Florida, 34613, United States
Pasco Hernando Oncology Associates PA
New Port Richey, Florida, 34652, United States
Augusta Oncology Associates, PC
Augusta, Georgia, 30901, United States
Cascade Cancer Center
Macon, Georgia, 31201, United States
Central Georgia Cancer Care
Macon, Georgia, 31201, United States
Northwest Georgia Oncology Center
Marietta, Georgia, 30060, United States
Northwestern University-Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Maine Center for Cancer Medicine
Scarborough, Maine, 04474-9308, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Baystate Medical Center
Springfield, Massachusetts, 01107, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48105, United States
Columbia Comprehensive Cancer Care Clinic & Research Institute
Jefferson City, Missouri, 65109, United States
Oncology Hematology Specialists, PA
Denville, New Jersey, 07134, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of New York
East Syracuse, New York, 13057, United States
Queens Cancer Center
Jamaica, New York, 11432, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Hematology Oncology of Northeast Pennsylvania
Dunmore, Pennsylvania, 18512, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29403, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Oncology Alliance
Glendale, Wisconsin, 53212, United States
Related Publications (1)
Schwartzberg LS, Tauer KW, Hermann RC, Makari-Judson G, Isaacs C, Beck JT, Kaklamani V, Stepanski EJ, Rugo HS, Wang W, Bell-McGuinn K, Kirshner JJ, Eisenberg P, Emanuelson R, Keaton M, Levine E, Medgyesy DC, Qamar R, Starr A, Ro SK, Lokker NA, Hudis CA. Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab. Clin Cancer Res. 2013 May 15;19(10):2745-54. doi: 10.1158/1078-0432.CCR-12-3177. Epub 2013 Feb 26.
PMID: 23444220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Chair
- Organization
- ACORN Research, LLC
Study Officials
- STUDY CHAIR
Lee S Schwartzberg, MD, FACP
Accelerated Community Oncology Research Network Inc
- STUDY CHAIR
Clifford A Hudis, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 28, 2007
Study Start
June 1, 2007
Primary Completion
September 1, 2010
Study Completion
November 1, 2012
Last Updated
May 20, 2014
Results First Posted
May 16, 2014
Record last verified: 2014-05