Breast CancerPhase 2NCT00453635
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
A Phase 2 study testing Docetaxel, Carboplatin and Herceptin in people with Breast Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer. 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?
- Docetaxel, Carboplatin and Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 10 sitesGreece
- Study dates
- Dec 2003to Nov 2008
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance status (WHO) 0-2
- Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
- HER-2 overexpression 2+ or 3+ using IHC or FISH +
- Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
- No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
- More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
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- No prior first line chemotherapy for metastatic disease
- Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
- Paraffin block from the primary tumor available in the research lab
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
- Adequate liver (Bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- Adequate cardiac function (LVEF > 50%)
- Informed consent
Who cannot join
- Pregnant or nursing
- Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
- Positive pregnancy test
- Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
- Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
- History of allergic reaction attributed to docetaxel
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- 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
10 sites in 1 country.
10 sites in 1 country
Greece10 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
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens
State General Hospital of Larissa
Athens
University Hospital of Crete
Heraklion, Crete, 71110
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
Read the detailed description
Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Carboplatin, Herceptin, Vinorelbine
- Keywords
- Cancer, Breast cancer, First line treatment, Docetaxel, Carboplatin, Herceptin, Vinorelbine
- 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.
DocetaxelDrug
Also called Taxotere
Docetaxel at the dose of 75mg/m^2 IV on day 1 every 3 weeks for 6 consecutive cycles
CarboplatinDrug
Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
HerceptinDrug
Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
VinorelbineDrug
Also called Navelbine
Vinorelbine at the dose of 60mg/m^2 per os,weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Docetaxel + Carboplatin + Herceptin (D/Carbo/Her) Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Herceptin |
| 2 | Experimental | Vinorelbine + Herceptin (VHer) Receives: Drug: Herceptin; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression between the two treatment arms
Measured: 1 year
Secondary outcomes (2)
Overall survival
Measured: 1 year
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.
- First posted29 Mar 2007 (estimated)
- Study startDec 2003
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Dimitris Mavroudis, MD, Principal investigator, University Hospital of Crete, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453635
- Sponsor's protocol ID
- CT/03.08
- Status last verified
- Mar 2012
- First submitted
- 28 Mar 2007
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00453635
- Acronym / sponsor ID
- CT/03.08
- Conditions
- Breast Cancer
- Keywords
- Cancer, Breast cancer, First line treatment, Docetaxel, Carboplatin, Herceptin, Vinorelbine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor accrual
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Dec 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 29 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
Detailed description
Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel, Drug: Carboplatin, Drug: HerceptinDocetaxel + Carboplatin + Herceptin (D/Carbo/Her) |
| 2 | Experimental | Drug: Herceptin, Drug: VinorelbineVinorelbine + Herceptin (VHer) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Performance status (WHO) 0-2
- Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
- HER-2 overexpression 2+ or 3+ using IHC or FISH +
- Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
- No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
Key exclusion criteria (9 listed)
- Pregnant or nursing
- Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
- Positive pregnancy test
- Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
- Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel at the dose of 75mg/m^2 IV on day 1 every 3 weeks for 6 consecutive cycles | Drug | 1 |
| CarboplatinCarboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles | Drug | 1 |
| HerceptinHerceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks | Drug | 1, 2 |
| VinorelbineAlso: NavelbineVinorelbine at the dose of 60mg/m^2 per os,weekly | Drug | 2 |
Primary outcome
Time to progression between the two treatment arms
Time frame: 1 year
2 secondary outcomes
Overall survival
Time frame: 1 year
Toxicity profile
Time frame: During the time of chemotherpy
Results and safety
The study was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitris Mavroudis, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Carboplatin and Herceptin in people with Breast Cancer, run by Hellenic Oncology Research Group at 10 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 13 inclusion and 9 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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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: 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 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?
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 Mar 2012.