Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.

Key facts

Study ID

NCT00622466

Run by

University of Texas Southwestern Medical Center

People needed

20

Starts

2008-04-23

Expected to finish

2016-10-01

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically* confirmed breast cancer
• Stage IV (metastatic) disease
• Radiographic evidence of metastases NOTE: *Histological confirmation of the actual metastasis is not required.
• Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan
• No prior radiotherapy unless growth has been documented following radiotherapy
• Primary tumor or metastatic tumor HER2-negative, defined as the following:
• Immunohistochemistry of 0 or 1+ OR the equivalent, if an automated quantitative assay is used
• HER2 fluorescent in situ hybridization (FISH) assay negative as defined by a HER2:chromosome 17 centromeric probe ratio < 1.8 (or < 2.2 if immunohistochemistry is less than 3+ or equivalent) OR equivalent values for negative FISH assays that do not normalize to chromosome 17
• Hormone-receptor positive (estrogen receptor-[ER] or progesterone receptor [PgR]-positive) disease or hormone receptor-negative (ER- or PgR-negative) disease
• Tumor block from initial breast cancer primary or a biopsy of a metastatic site must be available for correlative studies
• Brain metastases allowed provided the patient is stable after completion of treatment (i.e., surgery and/or radiotherapy), asymptomatic, and off steroids with 2 consecutive stable brain scans at least 4 weeks after radiotherapy

You may not qualify if…

• Bone-only or other nonmeasurable-only disease
• Newly diagnosed brain metastases
• PATIENT CHARACTERISTICS:
• Inclusion criteria:
• ECOG performance status 0-1
• Life expectancy > 6 months
• Menopausal status not specified
• WBC ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin < 1.5 times upper limit of normal (ULN)
• AST and ALT transaminases ≤ 2.5 times ULN (< 5 times ULN if liver involvement)
• Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min
• INR < 1.5 OR PT/PTT normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to and during (women and men) and for at least 3 months after (men) study therapy
• Able to swallow and absorb oral medications
• Exclusion criteria:
• Active or uncontrolled medical illness (e.g., active infection > CTCAE grade 2), including any of the following:
• HIV or chronic hepatitis B or C
• Uncontrolled diabetes
• NYHA class II-IV uncompensated congestive heart failure
• Unstable angina (anginal symptoms at rest)
• New onset angina (i.e., began within the past 3 months)

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.