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Breast CancerPhase 3NCT00440622

Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

A Phase 3 study testing Gemcitabine, Herceptin and Capecitabine (Xeloda) in people with Breast Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

Terminated

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

Official record
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Trial summary

The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Gemcitabine, Herceptin and Capecitabine (Xeloda)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
9 sitesGreece
Study dates
Apr 2003to Nov 2008
Phase
Phase 3
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent
  • Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
  • HER-2 overexpression 2+ or 3+ using IHC or FISH +
  • Measurable disease
  • At least one prior chemotherapy regimen
  • Not in a prior irradiation field
Show all 14Show fewer
  • No patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
  • No more than 25% of myeloproductive bone marrow irradiated. More than 4 weeks since prior radiotherapy and recovered
  • Age 18 - 75 year old
  • Performance status (WHO) 0-2
  • Life expectancy more than 12 weeks
  • Absolute neutrophil count > 1500/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
  • Adequate liver (bilirubin < 2 mg/dL, SGOT/SGPT < 2 times upper limit of normal, ALP < 3 times upper limit of normal, creatinine < 1.5 upper limit of normal
  • Adequate cardiac function (LVEF > 50%)

Who cannot join

  • Pregnant or nursing
  • Positive pregnancy test
  • Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
  • Motor or sensory neuropathy > grade 1 according to NCIC toxicity criteria
  • History of allergic reaction attributed to docetaxel
  • Psychiatric illness or social situation that would preclude study compliance
  • Other concurrent uncontrolled illness
  • Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Greece9 sites

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology

    Alexandroupoli

  • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology

    Athens

  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

    Athens

  • "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

    Athens

  • 401 Military Hospital of Athens

    Athens

  • Air Forces Military Hospital of Athens

    Athens

  • State General Hospital of Larissa, Dep of Medical Oncology

    Larissa

  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

    Piraeus

  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

    Thessaloniki

Other trials in Greece

About this study

Official title: A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer

The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.

Read the detailed description

This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.

Conditions
Breast Cancer
Being tested
Gemcitabine, Herceptin, Capecitabine (Xeloda)
Keywords
Cancer, Metastatic Breast cancer, Her-2 expression, Gemcitabine, Capecitabine, Herceptin
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.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

  • HerceptinDrug

    Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV

  • Capecitabine (Xeloda)Drug

    Also called Xeloda

    Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles

Study groups in NCT00440622
Study groupRoleWhat they receive
1ExperimentalGHer
Receives: Drug: Gemcitabine; Drug: Herceptin
2ExperimentalCapHer
Receives: Drug: Herceptin; Drug: Capecitabine (Xeloda)

What is being measured

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

  1. Time to progression (TTP) between the two treatment arms

    Measured: 1 year

Secondary outcomes (2)

  1. Overall survival

    Measured: 1 year

  2. Toxicity profile

    Measured: During the time of chemotherpy

Timeline

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

  1. First posted27 Feb 2007 (estimated)
  2. Study startApr 2003
  3. Primary completionNov 2008
  4. Study completionNov 2008

Why it stopped: Due to poor accrual

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440622
Sponsor's protocol ID
CT/03.09
Status last verified
Feb 2013
First submitted
26 Feb 2007
Last updated
13 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Herceptin and Capecitabine (Xeloda) in people with Breast Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

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 14 inclusion and 8 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 13 Feb 2013. 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 Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: Due to poor accrual). 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?

Time to progression (TTP) between the two treatment arms (time frame: 1 year). 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 NCT00440622.

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 Feb 2013.

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