BAY43-9006 - Phase II in Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101400
Recruitment Status : Completed
First Posted : January 11, 2005
Results First Posted : June 23, 2009
Last Update Posted : December 13, 2013
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer Drug: Sorafenib (Nexavar, BAY43-9006) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Subjects With Metastatic Breast Cancer.
Study Start Date : February 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg administered twice daily (b.i.d.)
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg administered twice daily (b.i.d.)

Primary Outcome Measures :
  1. Number of Subjects With Response (Complete or Partial) [ Time Frame: Until 30 days after termination of active therapy ]
    Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.

Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: Until progression occurs ]
    Time from start of treatment until progression was first documented.

  2. Time to Objective Response [ Time Frame: Until objective response occurs ]
    Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.

  3. Overall Response Duration [ Time Frame: Time from PR or CR to progression ]
    Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented.

  4. Survival Time [ Time Frame: Start of treatment to death ]
    After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).

  5. Number of Subjects With Stable Disease up to Cycle 4 [ Time Frame: Until 30 days after termination of active therapy ]
    Number of subjects who had not responded to treatment but had stable disease up to cycle 4.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Women with prior histologically documented diagnosis of breast cancer
  • Subjects with metastatic disease who have already received and failed at least one chemotherapy regimen for metastatic disease and, if ER/PgR +ve, have failed on at least adjuvant hormonal therapy
  • Subjects for whom trastuzumab treatment is not indicated, no longer effective or refused by the subjects
  • Four weeks since the last cytotoxic chemotherapy or clear evidence of progression on hormonal therapy
  • Subjects who have at least one measurable lesion by CT (Computed Tomography) scan or MRI (Magnetic Resonance Imaging) according to modified WHO Tumour Response Criteria
  • Subjects who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory evaluations:

    • Hemoglobin > 9.0 g/dl
    • Absolute neutrophil count (ANC) > 1,500/mm3
    • Platelet count = 100,000/µl
    • Total bilirubin =1.5 x the upper limit of normal.
    • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 2.5 x upper limit of normal (=5 x upper limit of normal for subjects with liver involvement of their cancer)
    • Amylase and lipase = 1.5 x the upper limit of normal
    • Serum creatinine = 3.0 x the upper limit of normal
    • Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists)
  • Subjects who give written informed consent prior to any study specific screening procedures with the understanding that the subject has the right to withdraw from the study at any time, without prejudice
  • Life expectancy of at least 12 weeks
  • Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumours [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)
  • Congestive heart failure > New York Heart Association (NYHA) Class II
  • Cardiac arrhythmia requiring anti-arrhythmic (excluding beta blockers or digoxin)
  • Active coronary artery disease or ischaemia
  • Active clinically serious bacterial or fungal infections (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3)
  • Known History of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
  • Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for 1 month prior to and following screening radiographic study)
  • Subjects with seizure disorders requiring medication (such as steroid or anti-epileptics)
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent
  • Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.

Excluded therapies include:

  • Anti-cancer chemotherapy, hormonal therapy or immunotherapy during the study or within 4 weeks of study entry. Mytomicin or nitroureas should not be given within 6 weeks of study entry
  • Significant surgery within 4 weeks prior to the start of study drug
  • Any bone marrow transplant or stem cell rescue within 4 months of the start of study drug
  • Radiotherapy during the study or within 3 weeks of the start of drug
  • Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF), within 3 weeks of study entry
  • Investigational drug therapy outside of this trial during or within 30 days prior to start of the study drug
  • Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice
  • Prior use of Raf-Kinase Inhibitors (RKI), Methyl Ethyl Ketone (MEK) or farnesyl transferase inhibitors
  • Concomitant treatment or use of St. John's Wort
  • Prior use of bevacizumab and all other drugs that target Vascular Endothelial Growth Factor (VEGF)/VEGF receptors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101400

Stuttgart, Baden-Württemberg, Germany, 70199
München, Bayern, Germany, 80637
Frankfurt, Hessen, Germany, 60590
Bologna, Italy, 40138
Milano, Italy, 20133
Milano, Italy, 20162
Parma, Italy, 43100
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Responsible Party: Bayer Identifier: NCT00101400     History of Changes
Other Study ID Numbers: 100555
First Posted: January 11, 2005    Key Record Dates
Results First Posted: June 23, 2009
Last Update Posted: December 13, 2013
Last Verified: November 2013

Keywords provided by Bayer:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs