NCT00548899

Brief Summary

The purpose of this study is to determine the efficacy and safety of sorafenib in the neoadjuvant setting in patients with primary breast cancer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2007

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

3.8 years

First QC Date

October 23, 2007

Last Update Submit

March 6, 2015

Conditions

Breast Cancer

Keywords

Neoadjuvant chemotherapyTargeted therapy

Outcome Measures

Primary Outcomes (1)

  • to establish the most feasible regimen of EC-P (P-EC) with sorafenib

    Time of surgery

Secondary Outcomes (5)

  • Safety of preoperative regimen

    Treatment to Surgery

  • Determine clinical response rate

    Time of surgery

  • Histopathological axillary nodal status after neoadjuvant therapy

    Time of surgery

  • Correlate baseline and change in tumor and serum genetic, gene expression and proteomic patterns with clinical and pathological response

    Baeline till time of surgery

  • pCR rate at surgery

    Treatment ot Surgery

Study Arms (1)

Sorafenib

OTHER

Single Arm: All patients receive sorafenib in addition to the established chemotherapy

Drug: Nexavar (Sorafenib)

Interventions

Nexavar (Sorafenib)DRUG

Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day

Sorafenib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral or bilateral primary carcinoma of the breast,
  • Tumor lesion in the breast with a palpable size of \>= 2 cm. The lesion has to be measurable in two-dimensions preferably by sonography. In case of inflammatory disease the extent of inflammation can be used as measurable lesion;
  • Patients should have stages of disease in which adjuvant chemotherapy would be considered.
  • Women of childbearing potential must have a negative serum pregnancy test
  • Negative HER-2/neu status
  • Karnofsky Performance status index \>= 80%;
  • Normal cardiac function
  • Laboratory requirements:
  • Absolute neutrophile count (ANC) \>= 2,0 x 109/L and Platelets \>= 100 x 109/L and Hemoglobin \>= 10 g/dL (\>= 6.2 mmol/L) INR ≤ 1.5 ULN and PTT ≤ 1.5 ULN within 14 days prior to enrolment ASAT or ALAT \< 2.5 x ULN Alkaline phosphatase ≤ 5 UNL. Patients with ASAT and/or ALAT \> 1,5 x UNL associated with alkaline phosphatase \> 2,5 x UNL are not eligible for the study Total bilirubin \< 1 X UNL Creatinine ≤ 175 µmol/L (2 mg/dl). The calculated creatinine clearance should be ≥ 60 mL/min.
  • Paraffin tumor tissue block and each one serum and one plasma sample centrally made available
  • Complete staging work-up within 3 months prior to registration.
  • Patients must be available and compliant for treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating or a cooperating center.

You may not qualify if:

  • Evidence of distant metastasis;
  • Prior chemotherapy for any malignancy;
  • Prior radiation therapy for breast cancer;
  • Preexisting rhagades at hand and feet and other skin problems (e.g. psoriasis)
  • Pregnant or lactating patients.
  • Pre-existing motor or sensory neuropathy of a severity \>= grade 2 by NCI criteria; 7. Concurrent treatment with: Chronic corticosteroids unless initiated \> 6 months prior to study entry and at low dose (\< 20 mg methylprednisolone or equivalent); Sex hormones. Prior treatment must be stopped before study entry; Patients with increased risk of bleeding due to concurrent therapeutic or prophylactic anticoagulative treatment. Low dose of coumarines are permitted.
  • Other experimental drugs or any other anti-cancer therapy; Drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days or their expected need 8. Other serious illness or medical condition:
  • Previous malignant disease without being disease-free of less than 5 years (except CIS of the Cervix and non-melanomatous skin cancer)
  • Known or suspected congestive heart failure (≥NYHA II) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension, rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease
  • Thrombotic or embolic events
  • Hemorrhage/bleeding event ≥ Grade 3 within 4 weeks prior study entry
  • Evidence or history of bleeding diathesis or coagulopathy
  • History of significant neurological or psychiatric disorders
  • Patients with seizure disorders requiring medication such as steroids or antiepileptics
  • Currently active infection
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

St. Gertrauden Krankenhaus

Berlin, 10713, Germany

Location

Klinikum der Universität zu Köln

Cologne, 50924, Germany

Location

Klinikum der J. W. Goethe Universität

Frankfurt am Main, 60590, Germany

Location

Henriettenstiftung

Hanover, 30559, Germany

Location

Elisabeth Krankenhaus

Kassel, 34177, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Klinikum Offenbach

Offenbach, 63069, Germany

Location

Klinikum Südstadt

Rostock, 18059, Germany

Location

Dr.-Horst-Schmidt-Kliniken GmbH

Wiesbaden, 65199, Germany

Location

Related Publications (1)

  • Loibl S, Rokitta D, Conrad B, Harbeck N, Wullner M, Warm M, Schwedler K, Gerber B, Schrader I, Eidtmann H, Mehta K, Fuhr U, von Minckwitz G. Sorafenib in the Treatment of Early Breast Cancer: Results of the Neoadjuvant Phase II Study - SOFIA. Breast Care (Basel). 2014 Jul;9(3):169-74. doi: 10.1159/000363430.

    PMID: 25177258RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Sibylle Loibl, MD

    GBG Forschungs GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

November 1, 2007

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

DE(9)