Breast CancerPhase 2NCT03887130
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
A Phase 2 study testing oral vinorelbine, Capecitabine and Gemcitabine 1250 mg/m² in people with Breast Cancer, run by Pierre Fabre Medicament.
Trial summary
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- oral vinorelbine, Capecitabine and Gemcitabine 1250 mg/m²
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2007to 18 Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the breast;
- Documented metastatic disease previously untreated by chemotherapy;
- HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
- Karnofsky Performance Status 70%.
Who cannot join
- Local relapse alone after conservative treatment or contra-lateral tumor;
- Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
- Concomitant hormonal therapy for metastatic breast cancer;
- Prior chemotherapy in the metastatic setting;
- Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
- Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.
About this study
Official title: Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.
- Conditions
- Breast Cancer
- Being tested
- oral vinorelbine, Capecitabine, Gemcitabine 1250 mg/m², Gemcitabine 1000 mg/m², Paclitaxel
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral vinorelbineDrug
Oral vinorelbine 60 mg/m² on day 1 \& day 8, for cycle 1, and then 80 mg/m² on day 1 \& day 8, every 3 weeks for subsequent cycles
CapecitabineDrug
Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
Gemcitabine 1250 mg/m²Drug
Gemcitabine 1250 mg/m² on day 1 \& day 8
Gemcitabine 1000 mg/m²Drug
Gemcitabine: 1000 mg/m² on day 1 \& 8
PaclitaxelDrug
Paclitaxel 175 mg/m² on day 1
DocetaxelDrug
Docetaxel 75 mg/m² on day 1
| Study group | Role | What they receive |
|---|---|---|
| Vinorelbine-Capecitabine (arm A) | Experimental | oral vinorelbine (OV) with capecitabine (CAP) Receives: Drug: oral vinorelbine; Drug: Capecitabine |
| Gemcitabine-Paclitaxel (arm B) | Active comparator | gemcitabine (GEM) in combination with paclitaxel (PAC) Receives: Drug: Gemcitabine 1250 mg/m²; Drug: Paclitaxel |
| Gemcitabine-Docetaxel (arm C) | Active comparator | gemcitabine (GEM) in combination with docetaxel (DOC) Receives: Drug: Gemcitabine 1000 mg/m²; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI:
Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Stable disease: no partial response or progression of the disease
Measured: From Baseline to disease progression or death, up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start27 Mar 2007
- Primary completion18 Apr 2013
- Study completion18 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887130
- Sponsor's protocol ID
- PM0259CA223B0
- Status last verified
- Feb 2024
- First submitted
- 3 Oct 2016
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03887130
- Acronym / sponsor ID
- PM0259CA223B0
- Conditions
- Breast Cancer
- Keywords
- Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2007 (actual)
- Primary completion
- 18 Apr 2013 (actual)
- Study completion
- 18 Apr 2013 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Posted 30 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vinorelbine-Capecitabine (arm A) | Experimental | Drug: oral vinorelbine, Drug: Capecitabineoral vinorelbine (OV) with capecitabine (CAP) |
| Gemcitabine-Paclitaxel (arm B) | Active comparator | Drug: Gemcitabine 1250 mg/m², Drug: Paclitaxelgemcitabine (GEM) in combination with paclitaxel (PAC) |
| Gemcitabine-Docetaxel (arm C) | Active comparator | Drug: Gemcitabine 1000 mg/m², Drug: Docetaxelgemcitabine (GEM) in combination with docetaxel (DOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed adenocarcinoma of the breast;
- Documented metastatic disease previously untreated by chemotherapy;
- HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
- Karnofsky Performance Status 70%.
Key exclusion criteria (6 listed)
- Local relapse alone after conservative treatment or contra-lateral tumor;
- Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
- Concomitant hormonal therapy for metastatic breast cancer;
- Prior chemotherapy in the metastatic setting;
- Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
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 |
|---|---|---|
| oral vinorelbineOral vinorelbine 60 mg/m² on day 1 \& day 8, for cycle 1, and then 80 mg/m² on day 1 \& day 8, every 3 weeks for subsequent cycles | Drug | Vinorelbine-Capecitabine (arm A) |
| CapecitabineCapecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14 | Drug | Vinorelbine-Capecitabine (arm A) |
| Gemcitabine 1250 mg/m²Gemcitabine 1250 mg/m² on day 1 \& day 8 | Drug | Gemcitabine-Paclitaxel (arm B) |
| Gemcitabine 1000 mg/m²Gemcitabine: 1000 mg/m² on day 1 \& 8 | Drug | Gemcitabine-Docetaxel (arm C) |
| PaclitaxelPaclitaxel 175 mg/m² on day 1 | Drug | Gemcitabine-Paclitaxel (arm B) |
| DocetaxelDocetaxel 75 mg/m² on day 1 | Drug | Gemcitabine-Docetaxel (arm C) |
Primary outcome
Disease Control Rate (DCR)
Time frame: From Baseline to disease progression or death, up to 6 years
Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable disease: no partial response or progression of the disease
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral vinorelbine, Capecitabine and Gemcitabine 1250 mg/m² in people with Breast Cancer, run by Pierre Fabre Medicament.
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 4 inclusion and 6 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Control Rate (DCR) (time frame: From Baseline to disease progression or death, up to 6 years). 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 30 Apr 2024.