Breast CancerPhase 2OVINTRANCT01242449
Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer
A Phase 2 study testing Trastuzumab and Vinorelbine in people with Breast Cancer, run by Vejle Hospital at 3 sites in Denmark.
Trial summary
This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer. Oral vinorelbine has shown the same overall response rate as i.v. 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?
- Trastuzumab and Vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 10 participants
- Where
- 3 sitesDenmark
- Study dates
- Nov 2010to Oct 2014
- 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
- Woman ≥ 18 years of age.
- PS 0-2. Expected lifetime of more than 12 weeks.
- Histologically verified breast cancer(adenocarcinoma)
- Primary tumor or metastasis is HER2 positive with IHC3+ or FISH+ (ratio ≥ 2.2).
- Documented metastatic breast cancer with min. one lesion measureable according to the RECIST 1.1 criteria. All solitary lesions must be verified cytologically/histologically if representing the only evidence of malignancy.
- The patient may have received (neo-) adjuvant chemotherapy (taxanes, anthracyclines and trastuzumab) and 1st line chemotherapy in combination with trastuzumab for metastatic disease.
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- The patient may have received previous adjuvant antihormonal treatment for metastatic breast cancer.
- The patient may receive radiation therapy, however, not against lesions used for response evaluation.
- Normal heart function, LVEF ≥ 50% measured by MUGA/EKKO.
- Normal bone marrow function: Hemoglobin ≥ 6 mmol/l, ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
- Normal liver function: Bilirubin ≤ 1.5 x upper normal level, ALAT ≤ 2.5 x upper normal level, BASP ≤ 2.5 x upper normal level (≤ 5 if presence of bone metastases).
- Normal renal function: Creatinine ≤ upper normal level. In case of raised creatinine the measured/calculated GFR must be ≥ 50 ml/min.
- Fertile women must present a negative pregnancy test and use contraceptives during and 3 months after treatment. An IUD without hormone is considered a safe contraceptive.
- Written and orally informed consent prior to any study related procedure.
Who cannot join
- Local recurrence or counter-lateral breast cancer without other dissemination.
- Pregnant or breastfeeding women.
- Clinical symptoms of CNS metastases, incl. meningeal carcinomatosis.
- Malabsorption syndrome or other disease affecting the gastrointestinal function. Resection of the ventriculus or the small intestine, which can affect absorption of oral vinorelbine.
- Dysphagia or other conditions preventing the patient from swallowing tablets.
- Mental or social conditions preventing treatment or follow-up.
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- Serious concurrent medical condition, such as:
- AMI within 12 months or unstable angina.
- Heart incompensation NYHA III or IV or uncontrolled hypertension (systolic > 150 mm/hg and/or diastolic >100 mm/hg).
- Serious arrythmia requiring medication, excl. atrial fibrillation and paroxystic supraventricular tachycardia.
- Active infection, uncontrolled diabetes or hypercalcemia.
- Other concurrent experimental treatment.
- Concurrent antihormonal treatment of metastatic breast cancer.
- Known neuropathia ≥ grade 2.
- Other previous malignant disease within the past 5 years excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
- Previous treatment with vinca alkaloid.
- Previous serious allergic or unexpected reactions to trastuzumab treatment.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Dept. of Oncology, Aalborg Sygehus
Aalborg, 9000
Dept. of Oncology, Esbjerg Hospital
Esbjerg, 6700
Department of Oncology, Vejle Hospital
Vejle, DK-7100
About this study
Official title: A Phase II Investigation of Oral Vinorelbine in Combination With Trastuzumab for 1st and 2nd Line Treatment of Women With Metastatic HER2 Positive Breast Cancer
This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer.
Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab, Vinorelbine
- Keywords
- Breast cancer, Metastatic, HER2 positive, vinorelbine
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks
VinorelbineDrug
Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsule on day 1 to be taken at the hospital, and on day 8 at home.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
CT scan and MUGA scan
Measured: Every 9 weeks. Up to 2 years
Secondary outcomes (2)
Progression free survival
CT scan
Measured: Every 9 weeks from date of first treatment until progression or death. Up to 2 years
Overall Survival
Measured: From date of inclusion until date of death. Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2014
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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troels Bechmann, MD, Principal investigator, Department of Oncology, Vejle HospitalErik H Jakobsen, MD, Study chair, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242449
- Sponsor's protocol ID
- 2010-021618-42
- Acronym
- OVINTRA
- Status last verified
- Mar 2015
- First submitted
- 16 Nov 2010
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Investigation of Oral Vinorelbine in Combination With Trastuzumab for 1st and 2nd Line Treatment of Women With Metastatic HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01242449
- Acronym / sponsor ID
- OVINTRA / 2010-021618-42
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Metastatic, HER2 positive, vinorelbine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Nov 2010 (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 phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer.
Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Woman ≥ 18 years of age.
- PS 0-2. Expected lifetime of more than 12 weeks.
- Histologically verified breast cancer(adenocarcinoma)
- Primary tumor or metastasis is HER2 positive with IHC3+ or FISH+ (ratio ≥ 2.2).
- Documented metastatic breast cancer with min. one lesion measureable according to the RECIST 1.1 criteria. All solitary lesions must be verified cytologically/histologically if representing the only evidence of malignancy.
Key exclusion criteria (17 listed)
- Local recurrence or counter-lateral breast cancer without other dissemination.
- Pregnant or breastfeeding women.
- Clinical symptoms of CNS metastases, incl. meningeal carcinomatosis.
- Malabsorption syndrome or other disease affecting the gastrointestinal function. Resection of the ventriculus or the small intestine, which can affect absorption of oral vinorelbine.
- Dysphagia or other conditions preventing the patient from swallowing tablets.
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 |
|---|---|---|
| TrastuzumabInitial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks | Drug | – |
| VinorelbineInitial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsule on day 1 to be taken at the hospital, and on day 8 at home. | Drug | – |
Primary outcome
Objective Response Rate
Time frame: Every 9 weeks. Up to 2 years
CT scan and MUGA scan
2 secondary outcomes
Progression free survival
Time frame: Every 9 weeks from date of first treatment until progression or death. Up to 2 years
Overall Survival
Time frame: From date of inclusion until date of death. Up to 2 years.
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 21 May 2015.
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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.
Troels Bechmann, MD principal investigator
Department of Oncology, Vejle Hospital
Erik H Jakobsen, MD study chair
Department of Oncology, Vejle Hospital
3 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 Trastuzumab and Vinorelbine in people with Breast Cancer, run by Vejle Hospital at 3 sites 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 14 inclusion and 17 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Objective Response Rate (time frame: Every 9 weeks. Up to 2 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 21 May 2015.