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Carcinoma Breast Stage IVPhase 2NCT01531764

BIBW 2992 (Afatinib) and Vinorelbine

A Phase 2 study testing BIBW 2992 in combination with vinorelbine in people with Carcinoma Breast Stage IV, run by University of Magdeburg at 12 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This open-label, single-arm, multicentre phase II trial will be performed in patients with intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and one first-line therapy in the metastatic setting. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Carcinoma Breast Stage IV
What is being tested?
BIBW 2992 in combination with vinorelbine
How many people
2 participants
Where
12 sitesGermany
Study dates
Jul 2012to Sep 2013
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

  • Female patients ≥ 18 years
  • Histologically confirmed diagnosis of intermediate HER2-overexpressing breast cancer
  • Stage IV metastatic disease
  • Must have received anthracycline-based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
  • Must have received one first-line chemotherapy for metastatic breast cancer
  • Must have (archived) tumour tissue sample available for central re- assessment of HER2 status and prove to be intermediate HER2-positive. HER2 intermediate status is defined as IHC 2+ and FISH-negativity.
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  • Must have at least one measurable lesion according to RECIST 1.1. Patient with only skin lesions will not be eligible.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • Life expectancy of at least six (6) months.
  • Written informed consent that is consistent with ICH-GCP guidelines.
  • Must be eligible for treatment with BIBW 2992 and vinorelbine.

Who cannot join

  • 1. Prior treatment with EGFR/HER2-targeted tyrosine kinase inhibitors, i.e. lapatinib
  • Prior treatment with vinorelbine
  • Known pre-existing interstitial lung disease
  • Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks (2 weeks for hormone therapy) prior to start of treatment with BIBW 2992 and vinorelbine.
  • Active brain metastases
  • Any other current malignancy or malignancy diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer).
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  • Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom, e.g. Crohn's disease, malabsorption or CTC grade ≥ 2 diarrhoea of any aetiology.
  • History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to start of study treatment.
  • Cardiac left ventricular function with resting ejection fraction of less than 50 %.
  • Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
  • Laboratory values according to specified ranges.
  • Women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial.
  • Pregnancy or breast-feeding.
  • Patients unable to comply with the protocol.
  • Known hepatitis B infection, known hepatitis C infection or known HIV carrier.
  • Known or suspected active drug or alcohol abuse.
  • Requirement for treatment with any of the prohibited concomitant medications
  • Any contraindications for therapy with vinorelbine or BIBW 2992.
  • Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
  • Use of any investigational drug within 4 weeks of start of treatment.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Klinikum St. Marien Amberg

    Amberg, Bavaria, 92224

  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum

    Berlin, State of Berlin, 10367

  • Onkologisches Zentrum Süd, Vivantes Tumorzentrum

    Berlin, State of Berlin, 12351

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Bottrop, North Rhine-Westphalia, 46236

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

  • Universitätsklinikum Frauenklinik Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Internistische Praxisgemeinschaft Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20249

  • OncoResearch Lerchenfled UG

    Hamburg, Free and Hanseatic City of Hamburg, 22081

  • Gynäkologische Praxis

    Hildesheim, Lower Saxony, 31134

  • Otto-von-Guericke-Universität Frauenklinik Magdeburg

    Magdeburg, Saxony-Anhalt, 39108

  • Hämato-Onkologische Schwerpunktpraxis

    München, Bavaria, 80638

  • Caritas-Krankenhaus, Onkologisches Zentrum Regensburg

    Regenburg, Bavaria, 93053

Other trials in Germany

About this study

Official title: Single-arm, Open-label, Multicentre Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) in Combination With Vinorelbine for the Treatment of Patients With Metastatic Breast Cancer With Intermediate HER2 Expression (HER2 2+ by Immunohistochemistry, Fluorescence In-situ Hybridisation (FISH) Negative) After Failure of First-line Therapy in the Metastatic Setting and Having Been Pre-treated With Anthracyclines

This open-label, single-arm, multicentre phase II trial will be performed in patients with intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and one first-line therapy in the metastatic setting.

The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are warranted.

Read more

Patients will be followed until progression. After progression, for the purpose of analysing overall survival, information on vital status and subsequent treatment will be collected.

The primary objective is to determine the 6-month progression free survival rate of BIBW 2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast cancer.

BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.

Being tested
BIBW 2992 in combination with vinorelbine
Keywords
Metastatic breast cancer, intermediate HER2 expression, Afatinib
Medical subject headings
Breast Neoplasms

What participants receive

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

  • BIBW 2992 in combination with vinorelbineDrug

    Also called Afatinib

    Patients will receive BIBW 2992 and vinorelbine chemotherapy. BIBW 2992: 40 mg oral (tablet) once daily Vinorelbine: 25 mg/m² on days 1 \& 8 in a 3-weekly course, intravenous, short infusion of about 10 minutes

What is being measured

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

  1. Progression-free survival based on tumor imaging according to RECIST 1.1 criteria.

    The primary objective is to determine the 6-month Progression free survival rate of BIBW 2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast cancer. The analysis will be based upon the evaluation of tumour imaging. Disease progression will be evaluated according to the RECIST 1.1 criteria.

    Measured: 6 months defined as the time from the date of treatment start

Secondary outcomes (2)

  1. Overall survival including assessment of objective response rate and time to progression.

    Objective Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1), Time-to-Progression and Overall Survival.

    Measured: From start of treatment until the date of first documented progression or death from any cause, whichever came first, assessed approximately up to 24 months.

  2. Number, intensity and incidence of adverse events

    Safety will be evaluated as indicated by number, intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.0.

    Measured: Start of treatment up to 28 days after the last administration trial medication.

Timeline

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

  1. First posted13 Feb 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

Why it stopped: The recruitment was discontinued because of failure to meet expected enrolment goals

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01531764
Sponsor's protocol ID
1200.137
Status last verified
Feb 2012
First submitted
9 Feb 2012
Last updated
18 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBW 2992 in combination with vinorelbine in people with Carcinoma Breast Stage IV, run by University of Magdeburg at 12 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 11 inclusion and 20 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: stopped early, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 was stopped early (reason given: The recruitment was discontinued because of failure to meet expected enrolment goals). Results are not available in the source record.

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?

Progression-free survival based on tumor imaging according to RECIST 1.1 criteria. (time frame: 6 months defined as the time from the date of treatment start). 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 NCT01531764.

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 18 Oct 2013.

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