Metastatic Breast CancerPhase 2VinCaTNCT00431704
VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer
A Phase 2 study testing vinorelbine, carboplatin and trastuzumab in people with Metastatic Breast Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- vinorelbine, carboplatin and trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Dec 2023
- 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
- Histological or cytological diagnosis of breast cancer
- Stage IV disease
- None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
- Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
- ECOG Performance Status 0-2
- Age >18 and < 75 years
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- Left Ventricular Ejection Fraction (LVEF) >50%
- Life expectancy >3 months
- Signed informed consent
Who cannot join
- Absence of measurable or evaluable disease
- Life expectancy < 3 months
- ECOG performance status > 2
- History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
- Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
- Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
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- Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl
- Creatinine > 1.5 x the upper normal limits
- GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases
- GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases
- Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
- Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- Male gender
- Pregnant or lactating women
- Refusal or incapacity to provide informed consent
- Inability to comply with follow up
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Naples, 80131
About this study
Official title: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.
Read the detailed description
The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.
- Conditions
- Metastatic Breast Cancer
- Being tested
- vinorelbine, carboplatin, trastuzumab
- Keywords
- advanced, her-2 positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinorelbineDrug
25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients
carboplatinDrug
AUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients
trastuzumabDrug
8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression
| Study group | Role | What they receive |
|---|---|---|
| vinorelbine, carboplatin, trastuzumab | Experimental | Not described Receives: Drug: vinorelbine; Drug: carboplatin; Drug: trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Measured: after 3 and 6 cycles of therapy
side effects
Measured: after every cycle of therapy
Secondary outcomes (2)
time to progression
Measured: at 12 months, end of study
overall survival
Measured: at 12 months, end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea De Matteis, M.D., Principal investigator, NCI Naples, Division of Medical Oncology CFrancesco Perrone, M.D., Ph.D., Principal investigator, NCI Naples, Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431704
- Sponsor's protocol ID
- VinCaT
- Other IDs
- 2006-003994-28
- Acronym
- VinCaT
- Status last verified
- Mar 2023
- First submitted
- 5 Feb 2007
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
- ClinicalTrials.gov ID
- NCT00431704
- Acronym / sponsor ID
- VinCaT / VinCaT
- Conditions
- Metastatic Breast Cancer
- Keywords
- advanced, her-2 positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Feb 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.
The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.
Detailed description
The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vinorelbine, carboplatin, trastuzumab | Experimental | Drug: vinorelbine, Drug: carboplatin, Drug: trastuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological or cytological diagnosis of breast cancer
- Stage IV disease
- None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
- Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
- ECOG Performance Status 0-2
Key exclusion criteria (16 listed)
- Absence of measurable or evaluable disease
- Life expectancy < 3 months
- ECOG performance status > 2
- History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
- Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
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 |
|---|---|---|
| vinorelbine25 mg/m2 days 1 and 8 every 3 weeks for 6 cycles, or up to 9 cycles for responding patients | Drug | vinorelbine, carboplatin, trastuzumab |
| carboplatinAUC 5 intravenously every 3 weeks for 6 cycles, up to 9 cycles for responding patients | Drug | vinorelbine, carboplatin, trastuzumab |
| trastuzumab8 mg/kg IV day 1, then 6 mg/kg IV every 3 weeks until disease progression | Drug | vinorelbine, carboplatin, trastuzumab |
Primary outcome
objective response rate
Time frame: after 3 and 6 cycles of therapy
side effects
Time frame: after every cycle of therapy
2 secondary outcomes
time to progression
Time frame: at 12 months, end of study
overall survival
Time frame: at 12 months, end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
Andrea De Matteis, M.D. principal investigator
NCI Naples, Division of Medical Oncology C
Francesco Perrone, M.D., Ph.D. principal investigator
NCI Naples, Clinical Trials Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vinorelbine, carboplatin and trastuzumab in people with Metastatic Breast Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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 Italy. 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?
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?
objective response rate (time frame: after 3 and 6 cycles of therapy). 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?
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 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.