Breast CancerPhase 1/2LAPADONCT01172223
Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer
A Phase 1/2 study testing Myocet (Non-pegylated liposomal doxorubicin (NPLD)), Paclitaxel and Lapatinib (GW572016, Tykerb) in people with Breast Cancer, run by Prof Dirk Elling at 1 site in Germany.
Trial summary
Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m^2 i.v. day 1 q3 weeks), Paclitaxel (175 mg/m^2 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?
- Myocet (Non-pegylated liposomal doxorubicin (NPLD)), Paclitaxel and Lapatinib (GW572016, Tykerb)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Dec 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer
- T1c N1-2 or T2 N0-2 disease
- HER2-positive tumours with 3+ intensity on immunohistochemical staining for HER2 or amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
- No prior systemic treatment regimens for breast cancer
- Adequate hematologic function (ANC 1500 cells/µl, platelet count 100000/µl, and hemoglobin 8g/dl).
- Serum creatinine concentration < 1.5 times the upper limit of normal (ULN) and/or creatinine clearance >60 ml/min
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- Bilirubin level < 1.5 X ULN
- Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram or MUGA scan)
- Karnofsky performance status 80%
- Age 18 years
- If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry
- Written informed consent prior to admission to this study
Who cannot join
- Male patients
- Inflammatory or bilateral breast cancer
- Evidence of distant metastases
- Previous systemic or local treatment for breast cancer (including surgery, radiotherapy, cytotoxic and endocrine treatments)
- Past or current history of other neoplasms, except for
- Curatively treated non-melanoma skin cancer
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- Adequately treated in situ carcinoma of the cervix
- Other cancer curatively treated and with no evidence of disease for at least 5 years
- Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure >115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy
- Preexisting sensoric or motor polyneuropathy Grade 2 according to NCI CTC
- Serious intercurrent medical or psychiatric illness, including serious active infection
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
- Detained persons or prisoners
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Trial of Primary Chemotherapy With Non-pegylated Liposomal Doxorubicin, Paclitaxel and Lapatinib in Patients With HER2-positive Early
Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with
- Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m^2 i.v. day 1 q3 weeks),
- Paclitaxel (175 mg/m^2 i.v. day 1 q3 weeks), and
- Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size <25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.
Read the detailed description
Breast cancer is the most common malignancy affecting females in northern Europe and North America, corresponding to an age-corrected annual incidence of 100 to 120 per 100000 females. Approximately 30-40% of all patients treated with curative intent will develop metastatic disease. Perioperative systemic treatment has made a major impact on relapse-free and overall survival of women with early-stage breast cancer [ , ] with therapeutic strategies being based on the endocrine responsiveness and the estimated risk of relapse defined by tumor size, axillary lymph node involvement, histologic and nuclear grade, lymphatic and/or vascular invasion, HER2/neu-overexpression and age [ ]. Perioperative therapy has traditionally been administered postoperatively, but chemotherapy is increasingly utilized in the preoperative setting as it can significantly improve the rate of breast conserving surgery, and new regimens can be evaluated rapidly and more precisely.
- Conditions
- Breast Cancer
- Being tested
- Myocet (Non-pegylated liposomal doxorubicin (NPLD)), Paclitaxel, Lapatinib (GW572016, Tykerb)
- Keywords
- HER2-positive, early 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.
Myocet (Non-pegylated liposomal doxorubicin (NPLD))Drug
60 mg/m^2 i.v. day 1 q3 weeks
PaclitaxelDrug
175 mg/m^2 i.v. day 1 q3 weeks
Lapatinib (GW572016, Tykerb)Drug
750-1500 mg/d orally daily until the day of the definitive surgery
| Study group | Role | What they receive |
|---|---|---|
| LAPADO | Experimental | Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m2 i.v. day 1 q3 weeks), Paclitaxel (175 mg/m2 i.v. day 1 q3 weeks), and Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Receives: Drug: Myocet (Non-pegylated liposomal doxorubicin (NPLD)); Drug: Paclitaxel; Drug: Lapatinib (GW572016, Tykerb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the optimal doses for NPLD, paclitaxel and lapatinib (phase I)
Measured: every 3 weeks
Evaluate the pathological response to NPLD, paclitaxel and lapatinib (phase II)
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startSep 2007
- Primary completionJan 2013
- Study completionDec 2013
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Dirk Elling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Dirk Elling, Sana-Klinikum Lichtenberg
- Investigators
- Dirk Elling, Principal investigator, Sana Klinikum Lichtenberg, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172223
- Sponsor's protocol ID
- LAPADO-Study
- Other IDs
- 2007-000924-42
- Acronym
- LAPADO
- Status last verified
- Oct 2016
- First submitted
- 28 Jul 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Primary Chemotherapy With Non-pegylated Liposomal Doxorubicin, Paclitaxel and Lapatinib in Patients With HER2-positive Early
- ClinicalTrials.gov ID
- NCT01172223
- Acronym / sponsor ID
- LAPADO / LAPADO-Study
- Conditions
- Breast Cancer
- Keywords
- HER2-positive, early breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Prof Dirk EllingUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jul 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.
Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with
- Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m^2 i.v. day 1 q3 weeks),
- Paclitaxel (175 mg/m^2 i.v. day 1 q3 weeks), and
- Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size <25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.
Detailed description
Breast cancer is the most common malignancy affecting females in northern Europe and North America, corresponding to an age-corrected annual incidence of 100 to 120 per 100000 females. Approximately 30-40% of all patients treated with curative intent will develop metastatic disease. Perioperative systemic treatment has made a major impact on relapse-free and overall survival of women with early-stage breast cancer [ , ] with therapeutic strategies being based on the endocrine responsiveness and the estimated risk of relapse defined by tumor size, axillary lymph node involvement, histologic and nuclear grade, lymphatic and/or vascular invasion, HER2/neu-overexpression and age [ ]. Perioperative therapy has traditionally been administered postoperatively, but chemotherapy is increasingly utilized in the preoperative setting as it can significantly improve the rate of breast conserving surgery, and new regimens can be evaluated rapidly and more precisely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAPADO | Experimental | Drug: Myocet (Non-pegylated liposomal doxorubicin (NPLD)), Drug: Paclitaxel, Drug: Lapatinib (GW572016, Tykerb)Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m2 i.v. day 1 q3 weeks), Paclitaxel (175 mg/m2 i.v. day 1 q3 weeks), and Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed breast cancer
- T1c N1-2 or T2 N0-2 disease
- HER2-positive tumours with 3+ intensity on immunohistochemical staining for HER2 or amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
- No prior systemic treatment regimens for breast cancer
- Adequate hematologic function (ANC 1500 cells/µl, platelet count 100000/µl, and hemoglobin 8g/dl).
Key exclusion criteria (14 listed)
- Male patients
- Inflammatory or bilateral breast cancer
- Evidence of distant metastases
- Previous systemic or local treatment for breast cancer (including surgery, radiotherapy, cytotoxic and endocrine treatments)
- Past or current history of other neoplasms, except for
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 |
|---|---|---|
| Myocet (Non-pegylated liposomal doxorubicin (NPLD))60 mg/m^2 i.v. day 1 q3 weeks | Drug | LAPADO |
| Paclitaxel175 mg/m^2 i.v. day 1 q3 weeks | Drug | LAPADO |
| Lapatinib (GW572016, Tykerb)750-1500 mg/d orally daily until the day of the definitive surgery | Drug | LAPADO |
Primary outcome
Determine the optimal doses for NPLD, paclitaxel and lapatinib (phase I)
Time frame: every 3 weeks
Evaluate the pathological response to NPLD, paclitaxel and lapatinib (phase II)
Time frame: every 6 weeks
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 2 Nov 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.
Dirk Elling principal investigator
Sana Klinikum Lichtenberg, Berlin
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 Myocet (Non-pegylated liposomal doxorubicin (NPLD)), Paclitaxel and Lapatinib (GW572016, Tykerb) in people with Breast Cancer, run by Prof Dirk Elling at 1 site in Germany.
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 12 inclusion and 14 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 2 Nov 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 Germany. 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 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 optimal doses for NPLD, paclitaxel and lapatinib (phase I) (time frame: every 3 weeks). The study lists 2 primary outcomes in all. 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 2 Nov 2016.