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Breast NeoplasmsPhase 2NCT00101400

BAY43-9006 - Phase II in Advanced Breast Cancer

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Breast Neoplasms and Breast Cancer, run by Bayer at 7 sites in 2 countries.

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 evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Breast Cancer
What is being tested?
Sorafenib (Nexavar, BAY43-9006)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
7 sitesin 2 countries
Study dates
Feb 2004to Jan 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age > 18 years
  • Women with prior histologically documented diagnosis of breast cancer
  • Subjects with metastatic disease who have already received and failed at least one chemotherapy regimen for metastatic disease and, if ER/PgR +ve, have failed on at least adjuvant hormonal therapy
  • Subjects for whom trastuzumab treatment is not indicated, no longer effective or refused by the subjects
  • Four weeks since the last cytotoxic chemotherapy or clear evidence of progression on hormonal therapy
  • Subjects who have at least one measurable lesion by CT (Computed Tomography) scan or MRI (Magnetic Resonance Imaging) according to modified WHO Tumour Response Criteria
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  • Subjects who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory evaluations:
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) > 1,500/mm3
  • Platelet count = 100,000/µl
  • Total bilirubin =1.5 x the upper limit of normal.
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 2.5 x upper limit of normal (=5 x upper limit of normal for subjects with liver involvement of their cancer)
  • Amylase and lipase = 1.5 x the upper limit of normal
  • Serum creatinine = 3.0 x the upper limit of normal
  • Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists)
  • Subjects who give written informed consent prior to any study specific screening procedures with the understanding that the subject has the right to withdraw from the study at any time, without prejudice
  • Life expectancy of at least 12 weeks
  • Signed informed consent must be obtained prior to any study specific procedures

Who cannot join

  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumours [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)
  • Congestive heart failure > New York Heart Association (NYHA) Class II
  • Cardiac arrhythmia requiring anti-arrhythmic (excluding beta blockers or digoxin)
  • Active coronary artery disease or ischaemia
  • Active clinically serious bacterial or fungal infections (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3)
  • Known History of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
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  • Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for 1 month prior to and following screening radiographic study)
  • Subjects with seizure disorders requiring medication (such as steroid or anti-epileptics)
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent
  • Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Excluded therapies include:
  • Anti-cancer chemotherapy, hormonal therapy or immunotherapy during the study or within 4 weeks of study entry. Mytomicin or nitroureas should not be given within 6 weeks of study entry
  • Significant surgery within 4 weeks prior to the start of study drug
  • Any bone marrow transplant or stem cell rescue within 4 months of the start of study drug
  • Radiotherapy during the study or within 3 weeks of the start of drug
  • Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF), within 3 weeks of study entry
  • Investigational drug therapy outside of this trial during or within 30 days prior to start of the study drug
  • Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice
  • Prior use of Raf-Kinase Inhibitors (RKI), Methyl Ethyl Ketone (MEK) or farnesyl transferase inhibitors
  • Concomitant treatment or use of St. John's Wort
  • Prior use of bevacizumab and all other drugs that target Vascular Endothelial Growth Factor (VEGF)/VEGF receptors

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Italy4 sites

  • Study site

    Bologna, 40138

  • Study site

    Milan, 20133

  • Study site

    Milan, 20162

  • Study site

    Parma, 43100

Other trials in Italy

Germany3 sites

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    München, Bavaria, 80637

  • Study site

    Stuttgart, Baden-Wurttemberg, 70199

Other trials in Germany

About this study

Official title: A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Subjects With Metastatic Breast Cancer.

The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.

Being tested
Sorafenib (Nexavar, BAY43-9006)
Keywords
Cancer
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

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

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Sorafenib 400 mg administered twice daily (b.i.d.)

Study groups in NCT00101400
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalSorafenib 400 mg administered twice daily (b.i.d.)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)

What is being measured

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

  1. Number of Subjects With Response (Complete or Partial)

    Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.

    Measured: Until 30 days after termination of active therapy

Secondary outcomes (5)

  1. Time to Progression

    Time from start of treatment until progression was first documented.

    Measured: Until progression occurs

  2. Time to Objective Response

    Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.

    Measured: Until objective response occurs

  3. Overall Response Duration

    Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented.

    Measured: Time from PR or CR to progression

  4. Survival Time

    After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).

    Measured: Start of treatment to death

  5. Number of Subjects With Stable Disease up to Cycle 4

    Number of subjects who had not responded to treatment but had stable disease up to cycle 4.

    Measured: Until 30 days after termination of active therapy

Timeline

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

  1. First posted11 Jan 2005 (estimated)
  2. Study startFeb 2004
  3. Primary completionJan 2006
  4. Study completionJan 2008

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101400
Sponsor's protocol ID
100555
Status last verified
Nov 2013
First submitted
10 Jan 2005
Last updated
13 Dec 2013
Data monitoring committee
No

Publications

  • Bianchi G, Loibl S, Zamagni C, Salvagni S, Raab G, Siena S, Laferriere N, Pena C, Lathia C, Bergamini L, Gianni L. Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer. Anticancer Drugs. 2009 Aug;20(7):616-24.

    PubMed 19739318

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Breast Neoplasms and Breast Cancer, run by Bayer at 7 sites in 2 countries.

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 19 inclusion and 23 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 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy, 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?

Yes. Results are posted in the registry (first posted 23 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Response (Complete or Partial) (time frame: Until 30 days after termination of active therapy). 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 NCT00101400, 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 13 Dec 2013.

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