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Breast CancerPhase 2SOFIANCT00548899

Neoadjuvant Chemotherapy Including Sorafenib in Women With Previously Untreated Primary Breast Cancer

A Phase 2 study testing Nexavar (Sorafenib) in people with Breast Cancer, run by GBG Forschungs GmbH at 9 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Nexavar (Sorafenib)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
9 sitesGermany
Study dates
Nov 2007to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%;
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  • 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.

Who cannot join

  • Patients with low or moderate risk, which are only doubtful candidates for adjuvant chemotherapy and do not fulfil the inclusion criteria No. 5.
  • 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.
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  • 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
  • History of HIV infection or chronic hepatitis B or C
  • Serious non healing wound, ulcer or bone fracture
  • Patients with prior immunosuppressive treatment
  • Severe pulmonary condition/illness
  • Disease significantly affecting gastrointestinal function,
  • Patients with severe liver disease
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
  • Definite contraindications for the use of corticosteroids
  • Inadequate general condition (not fit for anthracycline/taxane-containing chemotherapy)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • St. Gertrauden Krankenhaus

    Berlin, 10713

  • Klinikum der Universität zu Köln

    Cologne, 50924

  • Klinikum der J. W. Goethe Universität

    Frankfurt am Main, 60590

  • Henriettenstiftung

    Hanover, 30559

  • Elisabeth Krankenhaus

    Kassel, 34177

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Klinikum Offenbach

    Offenbach, 63069

  • Klinikum Südstadt

    Rostock, 18059

  • Dr.-Horst-Schmidt-Kliniken GmbH

    Wiesbaden, 65199

Other trials in Germany

About this study

Official title: Phase II Study of Neoadjuvant Epirubicin, Cyclophosphamide (EC) + Sorafenib Followed by Paclitaxel (P) + Sorafenib in Women With Previously Untreated

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

Read the detailed description

Epirubicin/Cyclophosphamide followed by Paclitaxel (EC/P) is a well tolerated regimen with high clinical activity. Histopathological complete remission after preoperative chemotherapy has a direct correlation with the disease-free and overall survival. The aim of combining a chemotherapy regime with sorafenib in the neoadjuvant setting is to increase the locoregional and systemic outcome of these patients

Conditions
Breast Cancer
Being tested
Nexavar (Sorafenib)
Keywords
Neoadjuvant chemotherapy, Targeted therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT00548899
Study groupRoleWhat they receive
SorafenibOtherSingle Arm: All patients receive sorafenib in addition to the established chemotherapy
Receives: Drug: Nexavar (Sorafenib)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Time of surgery

Secondary outcomes (5)

  1. Safety of preoperative regimen

    Measured: Treatment to Surgery

  2. Determine clinical response rate

    Measured: Time of surgery

  3. Histopathological axillary nodal status after neoadjuvant therapy

    Measured: Time of surgery

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

    Measured: Baeline till time of surgery

  5. pCR rate at surgery

    Measured: Treatment ot Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionSep 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00548899
Sponsor's protocol ID
GBG 45
Other IDs
2007-000124-41
Acronym
SOFIA
Status last verified
Mar 2015
First submitted
23 Oct 2007
Last updated
9 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25177258

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nexavar (Sorafenib) in people with Breast Cancer, run by GBG Forschungs GmbH at 9 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to establish the most feasible regimen of EC-P (P-EC) with sorafenib (time frame: Time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00548899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.

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