Preoperative Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Early Stage Breast Cancer



Status:Terminated
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2010
End Date:June 2015

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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

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.


Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast carcinoma.

- Early stage breast cancer (Stage I (tumor size ≥ 1cm), II and IIIA).

- Invasive breast cancer must be ER-negative, PR-negative, Her2-negative. If breast
cancer is Her2 2+ by immunohistochemistry (IHC), then FISH must be negative for Her2
gene amplification.

- No evidence of disease outside the breast or chest wall, except ipsilateral axillary
lymph nodes.

- Patients must have measurable disease as defined by palpable lesion with both
diameters ≥ 1cm measurable with caliper and/or a positive mammogram or ultrasound
with at least one dimension ≥ 1cm. Screening mammogram of the contralateral breast
must be performed within past 12 months per standard practice guidelines. Clip
placement is required for study entry. Baseline measurements of the indicator lesions
must be recorded on the Patient Registration Form. To be valid for baseline, the
measurements on clinical exam must have been made within 14 days if the mass is
palpable. If the mass is not palpable, a mammogram or MRI must be done within 14
days. If the mass is palpable, a diagnostic mammogram of the affected breast or MRI
must be done within 2 months prior to study entry.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 14 days of
study entry.

- Normal (greater than 50%) left ventricular ejection fraction (LVEF) by multigated
acquisition (MUGA) scan or echocardiography.

- Signed informed consent.

- Adequate organ function within 2 weeks of study entry:

- Absolute neutrophil count ≥ 1000/mm³, Hgb ≥ 9.0 g/dl and platelet count ≥
100,000/mm³

- Total bilirubin ≤ upper limit of normal

- Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance (CrCL) ≥ 50 mL/min
using the Cockroft Gault equation

- Serum glutamic oxaloacetic transaminase (SGOT)(AST) or serum glutamic pyruvic
transaminase (SGPT)(ALT) and alkaline phosphatase must be within the range
allowing for eligibility

- Patients must be ≥ 18 years.

- International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial
thromboplastin time (PTT) within normal limits. Patients receiving anti-coagulation
treatment with an agent such as warfarin or heparin may be allowed to participate.
For patients on warfarin, the INR should be measured prior to initiation of sorafenib
and monitored at least weekly, or as defined by the local standard of care, until INR
is stable.

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment.

- Women of childbearing potential and men must agree to use adequate contraception
(barrier method of birth control) prior to study entry and for the duration of study
participation.

- Patients with history of breast cancer greater than 5 years from initial diagnosis
and are disease free are eligible for the study. Patients with history of ductal
carcinoma in situ (DCIS) are eligible if there were treated with surgery alone.

Exclusion Criteria:

- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent,
targeted therapy or radiation therapy for current breast cancer.

- Metastatic disease on baseline staging scans.

- 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 grade 2 or greater 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.

- Thrombolic or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months.

- Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects
(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 New York Heart Association
(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.
We found this trial at
3
sites
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Atlanta, GA
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Atlanta, GA
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