Clinical trial NCT00493636 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: gemcitabine, sorafenib, placebo, capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        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
             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.

        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
             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).

          -  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
             randomization.

          -  Concurrent anti-cancer therapy other than gemcitabine/capecitabine and
             sorafenib/placebo.

          -  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
             assessments.

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