HER-2 Positive Breast CancerPhase 1NCT00788931
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
A Phase 1 study testing IV LBH589, Oral LBH589 and trastuzumab in people with HER-2 Positive Breast Cancer and Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 7 sites in 5 countries.
Trial summary
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER-2 Positive Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- IV LBH589, Oral LBH589 and trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Dec 2008to Aug 2010
- Phase
- Phase 1
- 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
- Age > 18 year old
- Confirmed HER2+ metastatic breast cancer
- Prior treatment and progression on trastuzumab
- Patients must have adequate organ functions
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Who cannot join
- Patients who have had surgery within last 2 weeks prior to starting the treatment
- Patients who receive concurrent therapy for brain metastases
- Impaired heart function or clinically significant heart disease
- Ongoing diarrhea
- Liver or renal disease with impaired hepatic or renal functions
- Concomitant use of any anti-cancer therapy or certain drugs
- Female patients who are pregnant or breast feeding
- Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Belgium2 sites
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Liège, 4000
Italy2 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Province of Macerata, MC, 62100
Australia1 site
Novartis Investigative Site
Woodville, South Australia, 5011
About this study
Official title: A Phase Ib, Open-label, Two Arm Study of i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel as Treatment for Adult Female Patients With HER2 Overexpressing Metastatic Breast Cancer (MBC)
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
- Being tested
- IV LBH589, Oral LBH589, trastuzumab, paclitaxel
- Keywords
- Breast Cancer, HER2 positive, adult-female, LBH589, HDAC inhibitor, panobinostat, metastatic breast, adult female patients
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV LBH589Drug
Oral LBH589Drug
trastuzumabDrug
paclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| IV LBH589 + trastuzumab + paclitaxel | Experimental | i.v. panobinostat Receives: Drug: IV LBH589; Drug: trastuzumab; Drug: paclitaxel |
| Oral LBH589 + trastuzumab + paclitaxel | Experimental | oral panobinostat Receives: Drug: IV LBH589; Drug: Oral LBH589; Drug: trastuzumab; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.
Measured: At least 21 day cycle for both arms
Secondary outcomes (2)
Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.
Measured: 4 weeks after end of treatment
To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.
Measured: throughout the study and 4 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788931
- Sponsor's protocol ID
- CLBH589C2114
- Other IDs
- 2007-004788-23
- Status last verified
- Nov 2012
- First submitted
- 24 Oct 2008
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label, Two Arm Study of i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel as Treatment for Adult Female Patients With HER2 Overexpressing Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT00788931
- Acronym / sponsor ID
- CLBH589C2114
- Keywords
- Breast Cancer, HER2 positive, adult-female, LBH589, HDAC inhibitor, panobinostat, metastatic breast, adult female patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2010 (actual)
- First posted
- 11 Nov 2008 (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 primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV LBH589 + trastuzumab + paclitaxel | Experimental | Drug: IV LBH589, Drug: trastuzumab, Drug: paclitaxeli.v. panobinostat |
| Oral LBH589 + trastuzumab + paclitaxel | Experimental | Drug: IV LBH589, Drug: Oral LBH589, Drug: trastuzumab, Drug: paclitaxeloral panobinostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 year old
- Confirmed HER2+ metastatic breast cancer
- Prior treatment and progression on trastuzumab
- Patients must have adequate organ functions
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Key exclusion criteria (8 listed)
- Patients who have had surgery within last 2 weeks prior to starting the treatment
- Patients who receive concurrent therapy for brain metastases
- Impaired heart function or clinically significant heart disease
- Ongoing diarrhea
- Liver or renal disease with impaired hepatic or renal functions
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 |
|---|---|---|
| IV LBH589 | Drug | IV LBH589 + trastuzumab + paclitaxel, Oral LBH589 + trastuzumab + paclitaxel |
| Oral LBH589 | Drug | Oral LBH589 + trastuzumab + paclitaxel |
| trastuzumab | Drug | IV LBH589 + trastuzumab + paclitaxel, Oral LBH589 + trastuzumab + paclitaxel |
| paclitaxel | Drug | IV LBH589 + trastuzumab + paclitaxel, Oral LBH589 + trastuzumab + paclitaxel |
Primary outcome
Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.
Time frame: At least 21 day cycle for both arms
2 secondary outcomes
Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.
Time frame: 4 weeks after end of treatment
To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.
Time frame: throughout the study and 4 weeks after end of treatment
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 19 Dec 2020.
- Results for LBH589C2114 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV LBH589, Oral LBH589 and trastuzumab in people with HER-2 Positive Breast Cancer and Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 7 sites in 5 countries.
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 5 inclusion and 8 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Italy, United States, Australia, Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel. (time frame: At least 21 day cycle for both arms). 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 19 Dec 2020.