View Clinical Trial (Medical Research Study)
1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy - NCT00493636-19106(Clinical Trial 175080)
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19106 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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August 16, 2010 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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