Metastatic Breast CancerPhase 1/2NCT01658358
ErbB2 Positive Metastatic Breast Cancer
A Phase 1/2 study testing Lapatinib and Lipo-Dox in people with Metastatic Breast Cancer, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Objectives: Phase I part Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 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?
- Lapatinib and Lipo-Dox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Sep 2014
- Phase
- Phase 1/2
- 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
- Histologically confirmed adenocarcinoma of the breast with evidence of metastatic disease
- Documented ErbB2 over expression or amplified disease in the invasive component of the primary or metastatic lesion as defined by:
- ErbB2 gene amplification by FISH(>6 ErbB2 gene copies per nucleus, or a FISH ratio (ErbB2 gene copies to chromosome 17 signals) of >than 2.2;
- Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥1 dimension as ≥20 mm by conventional techniques OR as ≥10 mm by spiral CT scan
- In phase II part, patients must be chemo-naïve in metastatic setting.
- In phase I part, patient may have received prior chemotherapy in metastatic setting.
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- In both phase I and II part, prior Anthracyclines allowed provided total dose of doxorubicin hydrochloride ≤240 mg/m² or epirubicin ≤ 600 mg/m².
- At least 6 months since prior Anthracyclines, and 6 weeks since prior Taxane.
- Patient must be informed and well understand that in current standard of treatment, suggested first line treatments for erbB-2 positive, visceral organ metastatic breast cancer are combination of chemotherapy with herceptin.
- In phase II part, patient must not have exposed to ant-erbB2 targeted therapy treatment in metastatic setting. Herceptin treatment in the neoadjuvant or adjuvant setting is permitted provide that at least 12 months has elapsed since the last dose of herceptin therapy.
- In phase I part, patient may have received prior anti-erbB-2 targeted treatment in metastatic setting.
- Hormone receptor and menopausal status are not specified. Prior treatment with endocrine therapy in the adjuvant or metastatic setting is permitted provided that therapy be discontinued.
- Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration.
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-1
- Patients must have normal organ and marrow function measured within 14 days prior to study entry as defined below:
- WBC ≥ 3,000/mm3
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Bilirubin normal
- AST/ALT ≤ 2.5 times upper limit of normal
- Normal serum creatinine OR creatinine clearance ≥60 mL/min
- LVEF ≥ 50% (by MUGA)
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow and retain medication
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
- Patient consent must be obtained.
Who cannot join
- Pregnant or lactating women.
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Prior therapy with concurrent use of Lapatinib.
- CNS metastasis.
- Ongoing other concurrent investigational agents or anticancer therapy
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious non-healing wound/ulcer/bone fracture, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with GI tract disease resulting in an inability to take medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Lapatinib (Tykerb) Plus Liposomal Doxorubicin Hydrochloride ( Lipo-Dox) for Patients With ErbB2 Positive Metastatic Breast Cancer
Objectives:
Phase I part
- Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer.
- Secondary Objectives:To define the safety profile; To observe the response rate and progression free survival
Phase II part
- Primary Objective :To determined the objective response rate of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer.
- Secondary Objectives:To define the safety profile; To determined the progression free survival
Read the detailed description
In phase I part Lapatinib (L) - dose level I, II 1000mg po daily dose level III, IV 1250mg po daily Intravenous Lipo Dox at the dose level reached on days 1 of a 21 days cycle• The recommended duration of combination treatment for each patient is at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. The treatment will stop if progressive disease, unacceptable toxicity or patient's refusal occurred. Intra patient escalation of dose level is allowed if no major toxicity noted.
In phase II part Patients will receive recommended dose according to phase I study result. The recommended duration of combination treatment for each patient is at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. The treatment will stop if progressive disease, unacceptable toxicity or patient's refusal occurred. Intra patient escalation of dose level is allowed if no major toxicity noted.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Lapatinib, Lipo-Dox
- Keywords
- ErbB receptor, tyrosine kinase inhibitor, Anthracycline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
Also called Tykerb
- dose level I, II 1000mg po daily
- dose level III, IV 1250mg po daily
Lipo-DoxDrug
Also called Liposomal doxorubicin hydrochloride
at the dose level reached on days 1 of a 21 days cycle. The recommended duration of combination treatment for each patient is at least 8 cycles,
| Study group | Role | What they receive |
|---|---|---|
| Phase I part :Systemic Therapy | Experimental | * Drug: Lapatinib
* Drug: Lipo-Dox Receives: Drug: Lapatinib; Drug: Lipo-Dox |
| Phase II part | Experimental | * Drug: Lapatinib
* Drug: Lipo-Dox Patients will receive recommended dose according to phase I study result. at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. Receives: Drug: Lapatinib; Drug: Lipo-Dox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I part recommended dose of the combination of lapatinib with Lipo-Dox
-Phase I part: To determine the recommended dose of the combination of lapatinib with Lipo-Dox
Measured: Phase I: 6 months
Secondary outcomes (1)
Objective Response Rate
-Phase II part: To determined the objective response rate
Measured: Phase II: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (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.
- More trials run by China Medical University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Fang Chiu, China Medical University Hospital
- Investigators
- Chang-Fang Chiu, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658358
- Sponsor's protocol ID
- EGF114081
- Status last verified
- Feb 2013
- First submitted
- 1 Aug 2012
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Lapatinib (Tykerb) Plus Liposomal Doxorubicin Hydrochloride ( Lipo-Dox) for Patients With ErbB2 Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01658358
- Acronym / sponsor ID
- EGF114081
- Conditions
- Metastatic Breast Cancer
- Keywords
- ErbB receptor, tyrosine kinase inhibitor, Anthracycline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 7 Aug 2012 (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.
Objectives:
Phase I part
- Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer.
- Secondary Objectives:To define the safety profile; To observe the response rate and progression free survival
Phase II part
- Primary Objective :To determined the objective response rate of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer.
- Secondary Objectives:To define the safety profile; To determined the progression free survival
Detailed description
In phase I part Lapatinib (L) - dose level I, II 1000mg po daily dose level III, IV 1250mg po daily Intravenous Lipo Dox at the dose level reached on days 1 of a 21 days cycle• The recommended duration of combination treatment for each patient is at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. The treatment will stop if progressive disease, unacceptable toxicity or patient's refusal occurred. Intra patient escalation of dose level is allowed if no major toxicity noted.
In phase II part Patients will receive recommended dose according to phase I study result. The recommended duration of combination treatment for each patient is at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. The treatment will stop if progressive disease, unacceptable toxicity or patient's refusal occurred. Intra patient escalation of dose level is allowed if no major toxicity noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I part :Systemic Therapy | Experimental | Drug: Lapatinib, Drug: Lipo-Dox* Drug: Lapatinib * Drug: Lipo-Dox |
| Phase II part | Experimental | Drug: Lapatinib, Drug: Lipo-Dox* Drug: Lapatinib * Drug: Lipo-Dox Patients will receive recommended dose according to phase I study result. at least 8 cycles, then, with continue combination treatment cycles or single lapatinib treatment (start with 1500 mg per day) at investigator's discretion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically confirmed adenocarcinoma of the breast with evidence of metastatic disease
- Documented ErbB2 over expression or amplified disease in the invasive component of the primary or metastatic lesion as defined by:
- ErbB2 gene amplification by FISH(>6 ErbB2 gene copies per nucleus, or a FISH ratio (ErbB2 gene copies to chromosome 17 signals) of >than 2.2;
- Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥1 dimension as ≥20 mm by conventional techniques OR as ≥10 mm by spiral CT scan
- In phase II part, patients must be chemo-naïve in metastatic setting.
Key exclusion criteria (7 listed)
- Pregnant or lactating women.
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Prior therapy with concurrent use of Lapatinib.
- CNS metastasis.
- Ongoing other concurrent investigational agents or anticancer therapy
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 |
|---|---|---|
| LapatinibAlso: Tykerb* dose level I, II 1000mg po daily * dose level III, IV 1250mg po daily | Drug | Phase I part :Systemic Therapy, Phase II part |
| Lipo-DoxAlso: Liposomal doxorubicin hydrochlorideat the dose level reached on days 1 of a 21 days cycle. The recommended duration of combination treatment for each patient is at least 8 cycles, | Drug | Phase I part :Systemic Therapy, Phase II part |
Primary outcome
Phase I part recommended dose of the combination of lapatinib with Lipo-Dox
Time frame: Phase I: 6 months
-Phase I part: To determine the recommended dose of the combination of lapatinib with Lipo-Dox
1 secondary outcome
Objective Response Rate
Time frame: Phase II: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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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.
Chang-Fang Chiu, PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lapatinib and Lipo-Dox in people with Metastatic Breast Cancer, run by China Medical University Hospital at 1 site in Taiwan.
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 28 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Feb 2013. 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 Taiwan. 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 combined 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.
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 was stopped early. 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?
Phase I part recommended dose of the combination of lapatinib with Lipo-Dox (time frame: Phase I: 6 months). 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 27 Feb 2013.