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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

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 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. Bilateral mammogram and 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 must have been
made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding
patient's entry in study.

- ECOG performance status 0 to 1 within 14 days of study entry

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

- Signed informed consent

- Adequate organ function within 2 weeks of study entry:

- Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count

- Total bilirubin < upper limit of normal

- Creatinine < 1.5 mg/dL or calculated CrCL >50mL/min using the Cockroft Gault

- SGOT(AST) or SGPT(ALT) and Alkaline Phosphatase must be within the range
allowing for eligibility

- Patients must be > 18 years

- INR < 1.5 or a PT/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

- 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 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. .

- 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

- 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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of pathologic complete response rate at the time of surgery after preoperative treatment

Outcome Time Frame:

at the time of surgery, after 24 weeks of preoperative treatment

Safety Issue:


Principal Investigator

Amelia Zelnak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

August 2014

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



Emory University Winship Cancer Institute Atlanta, Georgia  30322