Know Cancer

forgot password

A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer

Phase 1/Phase 2
19 Years
65 Years
Open (Enrolling)
Metastatic Breast Cancer

Thank you

Trial Information

A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer

Inclusion Criteria:

- Women affected by histologically proven metastatic breast cancer.

- Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2
amplification or immunohistochemistry 0-1+ for HER-2 expression.

- Female, age ≥ 18.

- Documented measurable disease by appropriate radiologic imaging according to RECIST
criteria (see Appendix E). Lesions in previously irradiated areas are not considered
measurable disease, unless progression has been documented post-radiation.

- ECOG performance status 0-1 (see Appendix B)

- Life expectancy > 6 months.

- Adequate bone marrow function, as indicated by:

- Hemoglobin ≥ 90 g/L

- Neutrophils ≥ 1.5 x 109/L

- Platelets ≥ 100 x 109/L

- Adequate renal function, as indicated by serum creatinine ≤1.5 times the upper limit
of normal and/or Creatinine Clearance calculated as >50% lower normal limit, or
estimated as ≥ 50 ml/min (Appendix C).

- Adequate liver function, as indicated by:

- bilirubin ≤ 1.5 times upper normal limit;

- AST and ALT ≤ 2 times upper normal limit.

- Left ventricular ejection fraction (LVEF) ≥50% as measured by either multigated
acquisition (MUGA) scan or echocardiogram (ECHO).

- No therapy for breast cancer in the 4 weeks preceding the therapy start.

- Women of childbearing potential must be using adequate contraception and have a
negative pregnancy test at the time of enrollment.

- Patient able to understand and give written informed consent.

Exclusion Criteria:

- Patients with locally advanced breast cancer or stage IIIb only.

- Presence of only non-measurable disease.

- Previous (neo)adjuvant chemotherapy with vinorelbine.

- Any previous anti-angiogenic therapy.

- Any previous chemotherapy for metastatic breast cancer. Previous hormonal treatments
or radiotherapy for metastatic disease are allowed.

- Radiotherapy, chemotherapy or hormonal therapy for breast cancer in the last 4 weeks
prior to starting the study treatment.

- Major surgery within 4 weeks of first study treatment, or minor surgery (including
placement of an access device) within 7 days of therapy start.

- Presence of life-threatening disease or central nervous system localizations.

- Evidence of HER-2 positive breast cancer, defined as FISH-positive for amplification
or score 3+ by immunohistochemistry.

- Any other possibly active primary tumor, except basal cell carcinoma of the skin, or
carcinoma in situ of the cervix.

- Clinically significant hepatic disease with respect to hepatitis B, hepatitis C,
cirrhosis or other liver diseases.

- Uncontrolled bacterial, viral or fungal infection.

- Previous history of ischemic disease.

- Patients with previous history of thrombo-embolic events, or with documented risk
factors for thrombotic disease other than cancer.

- History of gross hemorrhage within the past 6 months (e.g., hemoptysis or hematuria
requiring medical intervention).

- Uncontrolled hypertension.

- Other serious medical conditions, such as uncontrolled cardiac disease, severe
pulmonary disease, uncontrolled diabetes.

- Patient exhibiting confusion or disorientation.

- Any condition (medical, social, psychological, geographical) that would prevent
adequate follow-up.

- Patient is pregnant, or is breast-feeding, or is unwilling to use adequate

- Failure to give informed consent.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Lawrence Panasci

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University


Canada: Health Canada

Study ID:

McG 0713



Start Date:

October 2007

Completion Date:

December 2011

Related Keywords:

  • Metastatic Breast Cancer
  • To evaluate the use of sorafenib added to vinorelbine chemotherapy, to find out which are the doses of two drugs can be safely combined
  • Breast Neoplasms