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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- 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

- Prior hormonal therapy allowed provided it has been discontinued prior to

- 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.

Exclusion Criteria:

- 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

- 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

- Any other hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks of

- 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).

- Previous or concurrent cancer that is distinct in primary site or histology from
breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma,
superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 5 years
prior to randomization.

- Known or suspected allergy to sorafenib or gemcitabine/capecitabine.

- Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of

- Concurrent anti-cancer therapy other than gemcitabine/capecitabine and

- Prior treatment with any agent that targets VEGF or VEGFR (licensed or
investigational), except bevacizumab.

- Women who are pregnant or breast-feeding.

- Use of any investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding randomization.

- Inability to comply with protocol and/or not willing or not available for follow-up

- Any condition which in the investigator's opinion makes the patient unsuitable for
the study participation.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

From the date of randomization to the 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.

Safety Issue:


Principal Investigator

Lee S Schwartzberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Accelerated Community Oncology Research Network Inc


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Ingalls Memorial Hospital Harvey, Illinois  60426
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Rush University Medical Center Chicago, Illinois  60612-3824
Boston Medical Center Boston, Massachusetts  02118
Sutter Cancer Center Sacramento, California  95816
Baystate Medical Center Springfield, Massachusetts  01199
Long Beach Memorial Medical Center Long Beach, California  90806
Front Range Cancer Specialists Fort Collins, Colorado  80528
Washington Cancer Institute Washington, District of Columbia  20010
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Highlands Oncology Group Springdale, Arkansas  72764
Pennsylvania Oncology Hematology Associates Philadelphia, Pennsylvania  19107
California Pacific Medical Center San Francisco, California  94115
Georgetown University Medical Center Washington, District of Columbia  20007
California Cancer Care Greenbrae, California  94904
The West Clinic Memphis, Tennessee  38120
Northern Indiana Cancer Research Consortium South Bend, Indiana  
North Coast Cancer Care Sandusky, Ohio  44870
Maine Center for Cancer Medicine Scarborough, Maine  04074
Oncology Associates of Bridgeport Trumball, Connecticut  06611
Oncology Alliance Milwaukee, Wisconsin  53215
Augusta Oncology Associates, PC Augusta, Georgia  30901
University of California San Francisco Comprehensive Cancer Center San Francisco, California  94115
Pasco Hernando Oncology Associates PA Brooksville, Florida  34613
Queens Cancer Center Jamaica, New York  11432
Northwest Georgia Oncology Center Marietta, Georgia  30060
Central Georgia Cancer Care Macon, Georgia  31201
Charleston Hematology Oncology Associates Charleston, South Carolina  29403
Providence Cancer Center / Katmai Oncology Group LLC Anchorage, Alaska  99508
Compassionate Cancer Care-Corona Corona, California  92879
Compassionate Cancer Care-Fountain Valley Fountain Valley, California  92879
Compassionate Cancer Care-Riverside Riverside, California  92501
Hematology Oncology PC / Bennett Cancer Center Stamford, Connecticut  06902
Cascade Cancer Center Macon, Georgia  31201
Northwestern University-Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois  60611
Quincy Medical Group Quincy, Illinois  62301
Columbia Comprehensive Cancer Care Clinic & Research Institute Jefferson City, Missouri  65109
Oncology Hematology Specialists, PA Denville, New Jersey  07134
Hematology Oncology Associates of New York East Syracuse, New York  13057
Hematology Oncology of Northeast Pennsylvania Dunmore, Pennsylvania  18512