1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Accelerated Community Oncology Research Network
• Collaborators: Amgen; Onyx Pharmaceuticals
• Treatments: Bevacizumab; Capecitabine; Gemcitabine; Niacinamide; Sorafenib

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.