Preoperative Clinical Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Triple Negative (ER-, PR-, Her2-)Early Stage Breast Cancer
Verified May 2014 by Emory University
Information provided by (Responsible Party):
Amelia Zelnak, Emory University
First received: September 1, 2010
Last updated: May 21, 2014
Last verified: May 2014
The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and sorafenib can shrink the size of your breast tumor and allow you to preserve your breast. Sorafenib is a newer drug that targets blood vessel formation and may help the chemotherapy work better. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||WCI1590-08: Phase II Neoadjuvant Trial of Sorafenib in Combination With Cisplatin Followed by Dose Dense Paclitaxel for ER-, PR-, Her2- (Triple Negative) Early-Stage Breast Cancer
Primary Outcome Measures:
- Rate of pathologic complete response rate at the time of surgery after preoperative treatment [ Time Frame: at the time of surgery, after 24 weeks of preoperative treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical response rate, safety, disease-free survival, overall survival [ Time Frame: during 24 weeks of therapy and during routine follow-up after study completion ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2015 (Final data collection date for primary outcome measure)
Experimental: Arm 1
Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Other Name: Nexavar
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. .
- Medical, psychological or surgical condition which the investigator feels might compromise study participation.
- History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
- Evidence of any grade sensory and/or peripheral neuropathy.
- Serious,uncontrolled, concurrent infection(s).
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Pregnant or lactating women are not eligible. Women or men of childbearing potential not using a reliable and appropriate contraceptive method are not eligible. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem.
- Evidence or history of bleeding diathesis or coagulopathy
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194869
|Emory University Winship Cancer Institute
|Atlanta, Georgia, United States, 30322 |
||Amelia Zelnak, MD
No publications provided
||Amelia Zelnak, MD, Emory University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2010
||May 21, 2014
||United States: Institutional Review Board
United States: Food and Drug Administration
Keywords provided by Emory University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
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