Breast CancerPhase 2XeNaNCT01941771
Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer
A Phase 2 study testing Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) and Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) in people with Breast Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study hypothesis is that metronomic treatment is more efficient than standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) and Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Mar 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
- WHO performance status < 3
Who cannot join
- Former treatment with Capecitabine or Vinorelbine
- Patients who have received more than one line of chemotherapy for metastatic disease
- Brain metastases
- Malabsorption syndrome
- Abnormal organ function
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Aarhus University Hospital
Aarhus, Aarhus C, 8000
About this study
Official title: Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer.
The study hypothesis is that metronomic treatment is more efficient than standard treatment.
Read the detailed description
Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status < 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).
- Conditions
- Breast Cancer
- Being tested
- Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda), Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)
- Keywords
- Breast cancer, Metronomic chemotherapy, Vinorelbine, Navelbine, Capecitabine, Xeloda, Antineoplastic Agents
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)Drug
Also called Vinorelbine (Navelbine oral), Capecitabine (Xeloda)
Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.
Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)Drug
Also called Other Names:, Vinorelbine (Navelbine oral), Capecitabine (Xeloda)
Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule. Receives: Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) |
| Arm B | Experimental | Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule. Receives: Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is overall response rate i both arms.
Response evaluation at 3rd and 6th cycle by resist criterias. The number of patients that respond to treatment in percent of the total number of patients treated.
Measured: up to 60 month
Secondary outcomes (2)
Time to progression.
Number of days from start of treatment to progression of disease assessed up to 60 months
Measured: up to 60 month
Overall survival.
Number of days from start of treatment to death assessed up to 60 months.
Measured: up to 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionMar 2015
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Responsible party
- Principal investigator, Sven Langkjer, University of Aarhus
- Investigators
- Sven Tyge Langkjer, MD, PhD, Principal investigator, University hospital of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941771
- Sponsor's protocol ID
- EUDRACT nr. 2011-003564-72
- Other IDs
- 2011-003564-72
- Acronym
- XeNa
- Status last verified
- Oct 2016
- First submitted
- 5 Sep 2012
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT01941771
- Acronym / sponsor ID
- XeNa / EUDRACT nr. 2011-003564-72
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Metronomic chemotherapy, Vinorelbine, Navelbine, Capecitabine, Xeloda, Antineoplastic Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Sep 2013 (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 study hypothesis is that metronomic treatment is more efficient than standard treatment.
Detailed description
Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status < 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule. |
| Arm B | Experimental | Drug: Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
- WHO performance status < 3
Key exclusion criteria (6 listed)
- Former treatment with Capecitabine or Vinorelbine
- Patients who have received more than one line of chemotherapy for metastatic disease
- Brain metastases
- Malabsorption syndrome
- Abnormal organ function
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 |
|---|---|---|
| Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)Also: Vinorelbine (Navelbine oral), Capecitabine (Xeloda)Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule. | Drug | Arm B |
| Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)Also: Other Names:, Vinorelbine (Navelbine oral), Capecitabine (Xeloda)Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule. | Drug | Arm A |
Primary outcome
Primary endpoint is overall response rate i both arms.
Time frame: up to 60 month
Response evaluation at 3rd and 6th cycle by resist criterias. The number of patients that respond to treatment in percent of the total number of patients treated.
2 secondary outcomes
Time to progression.
Time frame: up to 60 month
Overall survival.
Time frame: up to 60 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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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.
Sven Tyge Langkjer, MD, PhD principal investigator
University hospital of Aarhus
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 Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda) and Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda) in people with Breast Cancer, run by University of Aarhus at 1 site in Denmark.
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 2 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 28 Oct 2016. 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 Denmark. 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 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?
Primary endpoint is overall response rate i both arms. (time frame: up to 60 month). 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 28 Oct 2016.