AzTrials
AzTrials

Carcinoma Breast Stage IVPhase 1NCT00199212

PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2

A Phase 1 study testing Combination of trastuzumab and PS-341 in people with Carcinoma Breast Stage IV, run by Jules Bordet Institute at 1 site in Belgium.

Completed

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

Official record
Search all trials

Trial summary

The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly. 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?
Combination of trastuzumab and PS-341
How many people
19 participants
Where
1 siteBelgium
Study dates
Oct 2003to Dec 2007
Phase
Phase 1
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 gender
  • Age >= 18 years
  • ECOG performance status < 2
  • Histologically proven diagnosis of breast cancer
  • Locally advanced and/or metastatic disease
  • Life expectancy of three months or longer
Show all 34Show fewer
  • No concurrent second malignancy (except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the cervix or contralateral breast cancer). Any prior second malignancy must be in remission for >= 5 years (except for contralateral breast cancer).
  • No other serious illness or medical condition including:
  • History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of recent (< 6 months) transmural infarction on electrocardiogram (ECG); poorly controlled hypertension (e.g. systolic > 180 mmHg or diastolic greater than 100 mmHg); clinically significant valvular heart disease; or high-risk uncontrolled arrhythmias.
  • Chronic lung disease
  • History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent, including psychotic disorders, mental retardation, and dementia.
  • Active concurrent infection
  • No symptomatic central nervous system (CNS) metastases
  • No rapidly progressive visceral metastases requiring immediate chemotherapy
  • No concurrent anti-cancer treatment is allowed.
  • Prior investigational biological agents are allowed, with the exception of anti-HER-2 therapy for any reason.
  • Previous hormonal therapy is allowed, as adjuvant and/or for metastatic breast cancer (MBC).
  • Adjuvant and MBC chemotherapy allowed, provided that a minimum of 4 weeks interval has elapsed between last chemotherapy administration and first study drug dose. All patients who, in the opinion of the investigator, could benefit from single agent Herceptin® and are not considered suitable for treatment with chemotherapy plus Herceptin® can be considered for this protocol.
  • A maximum cumulative dose of previous doxorubicin < 360 mg/m2 or a maximum cumulative dose of epirubicin < 720 mg/m2
  • Concomitant use of bisphosphonates is allowed, however if bisphosphonates are started during the trial for worsening bone pain, patients should be assessed for possible progressive disease.
  • Adequate organ function as defined by:
  • Neutrophils >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Bilirubin <= 1.5 x upper limit of normal (ULN)
  • Transaminases <= 2.5 x ULN or <= 5 x ULN if liver metastasis
  • Creatinine <= 1.5 x ULN
  • Overexpression of HER-2 in the invasive component of the primary tumor, according to one of the following definitions:
  • 3+ overexpression by immunohistochemistry (IHC) or
  • 2+ overexpression by IHC and fluorescence in situ hybridization (FISH) test demonstrating c-erbB2 gene amplification (ratio of c-erbB2 gene signals to centromere 17 signals > 2)
  • Baseline left ventricular ejection fraction (LVEF) > 50% measured by multiple gated acquisition scan (MUGA) or echocardiography
  • Evaluable or uni-dimensionally measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Women of childbearing potential must have a negative serum or urine pregnancy test and be willing to use acceptable methods of birth control.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Before patient registration/randomization, informed consent must be given according to International Conference of Harmonization/European Union Good Clinical Practice (ICH/EU GCP), and national/local regulations.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Jules Bordet Institute

    Brussels, 1000

Other trials in Belgium

About this study

Official title: A Phase I, Open Label, Dose-escalating Study of the Proteasome Inhibitor PS-341 in Combination With Two Schedules of Herceptin, in Patients With Advanced Breast Cancer That Overexpresses HER-2

The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.

Read the detailed description

Phase 1 study to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) given either weekly or 3-weekly.

Additionally, hints about efficacy of the combination will be looked upon.

Being tested
Combination of trastuzumab and PS-341
Keywords
HER-2 positive, metastatic breast cancer patients
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Combination of trastuzumab and PS-341Drug

    Also called PS-341, velcade, trastuzumab, herceptine

    Trastuzumab and velcade are used according standard procedure

What is being measured

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

  1. Feasibility and maximum tolerated dose

    Combination of Velcade and Herceptine in breast metastatic patients

    Measured: before recurrence

  2. Time of recurrence

    safety and tolerability of combinaison before recurrence of metastatic breast cance

    Measured: time of recurrence

Secondary outcomes (1)

  1. Response rate

    Tolerability and safety of combination of velcade and Herceptine

    Measured: time before response rate

Timeline

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

  1. First posted20 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionDec 2007
  4. Study completionDec 2007

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00199212
Sponsor's protocol ID
Herceptin-proteasome inhibitor
Status last verified
Feb 2011
First submitted
13 Sep 2005
Last updated
24 Feb 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Combination of trastuzumab and PS-341 in people with Carcinoma Breast Stage IV, run by Jules Bordet Institute at 1 site in Belgium.

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 34 inclusion and 0 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 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Feasibility and maximum tolerated dose (time frame: before recurrence). The study lists 2 primary outcomes in all. 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 NCT00199212.

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 24 Feb 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in