Breast CancerPhase 1/2NCT00450892
Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer
A Phase 1/2 study testing docetaxel+lapatinib, docetaxel + trastuzumab and docetaxel + trastuzumab + lapatinib in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 5 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel+lapatinib, docetaxel + trastuzumab and docetaxel + trastuzumab + lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Feb 2007to Jul 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer meeting the following criteria:
- Phase I
- Locally advanced or inflammatory disease, or specified subgroup of large operable disease for whom neoadjuvant chemotherapy is appropriate, defined as any 1 of the following:
- Clinical stage T4a-d, any N (inflammatory breast carcinoma: tumor mass, breast enlargement, oedema and warmth of the skin are often present but not mandatory for the diagnosis)
- Any clinical T, N2 or N3 (ipsilateral supraclavicular nodes)
- cT3cN0,1 any estrogen receptor (ER)
- cT2cN1 any ER
- cT2cN0 ER negative
- Presence of bilateral breast cancer is allowed
- No bone, liver, or other extensive metastases
- Minimal lung, skin, or nodal metastases may be allowed at the discretion of the investigator (phase I only)
- Phase II
- Locally advanced or inflammatory breast cancer, defined as any 1 of the following:
- Clinical T4a-d, any N (inflammatory breast carcinoma: tumor mass, breast enlargement, oedema and warmth of the skin are often present but not mandatory for the diagnosis)
- Any clinical T, N2 or N3 (ipsilateral supraclavicular nodes)
- And M0
- Bilateral breast cancer is allowed provided only 1 side is HER2-positive
- Any large resectable T2 or T3 breast cancers, M0
- HER2-positive disease by immunohistochemistry, fluorescent in situ hybridization, and/or chromogenic in situ hybridization
- No CNS involvement
- Two frozen trucuts for every core biopsy indicated by the translational research study
- Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-positive or negative tumor
PATIENT CHARACTERISTICS:
- Female
- WHO performance status 0-2
- Hemoglobin > 10.0 g/dL
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST and ALT < 3 times ULN
- Creatinine < 1.5 times ULN
- No other malignancies within the past 3 years except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix (phase II)
- LVEF normal by MUGA or ECHO
- ECG normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception 2 weeks prior to, during, and for 1 month after completion of study treatment
- No current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease not requiring therapy as per investigator assessment)
- No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
- History of documented congestive heart failure
- High-risk uncontrolled arrhythmias
- Angina pectoris requiring antianginal medication
- Clinically significant valvular heart disease
- Evidence of transmural infarction on ECG
- Poorly controlled hypertension, defined as systolic blood pressure (BP) > 180 mm Hg or diastolic BP > 100 mm Hg
- Able to swallow and retain oral medication
- Accessible for repeat dosing and follow up
- No concurrent grapefruit juice
- No active or uncontrolled infection
- No other serious illness
- No malabsorption syndrome
- No other medical condition (i.e., history of chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis)
- No psychological, familial, sociological, or geographical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
- No prior therapy for any cancer, including chemotherapy, radiotherapy, or hormonal therapy for breast cancer (phase I)
- No prior epidermal growth factor receptor- or HER2-targeted therapy or antibody therapy (phase I)
- More than 10 days since prior and no concurrent CYP3A4 inducers or inhibitors
- More than 14 days since prior and no concurrent herbal infusions or dietary supplements
- No antacids 1 hour before or after lapatinib ditosylate administration
- No other concurrent investigational therapy or anticancer therapy
- No concurrent prophylactic antibiotics
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
France9 sites
Institut Bergonie
Bordeaux
Institut Bergonié
Bordeaux
CHRU de Limoges
Limoges
Centre Leon Berard
Lyon
CRLC Val D'Aurelle
Montpellier
Centre Henri Becquerel
Rouen
Hopital Rene Huguenin - Institut Curie
Saint-Cloud
Centre Paul Strauss
Strasbourg
Institut Gustave Roussy
Villejuif
Switzerland2 sites
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
Geneva
Centre Hospitalier Universitaire Vaudois
Lausanne
About this study
Official title: A Phase I-II Study of Lapatinib and Docetaxel as Neoadjuvant Treatment for HER-2 Positive Locally Advanced/Inflammatory or Large Operable Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of neoadjuvant therapy comprising docetaxel and lapatinib ditosylate before or after fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC chemotherapy) in patients with HER2-positive locally advanced, inflammatory, or large resectable breast cancer. (Phase I)
- Determine the safety of this regimen in these patients. (Phase I)
- Determine the pathological complete response rate in patients treated with neoadjuvant docetaxel and lapatinib ditosylate followed by FEC chemotherapy, and with neoadjuvant docetaxel and trastuzumab (Herceptin®) followed by FEC chemotherapy. (Phase II)
Secondary
- Determine the biological activity (i.e., changes in apoptosis and proliferation markers [PTEN mutation and function, pAkt, mTOR, and associated proteins]) of neoadjuvant docetaxel and lapatinib ditosylate in these patients. (Phase I)
- Determine adverse events or biological modifications. (Phase I)
- Determine the tolerability of these regimens in these patients. (Phase II)
- Determine the clinical activity of these regimens. (Phase II)
- Identify genes that may predict response in patients treated with docetaxel and lapatinib ditosylate. (Phase II)
OUTLINE: This is a multicenter, open-label, phase I dose-escalation study of docetaxel and lapatinib ditosylate followed by a randomized phase II study. Patients enrolled in the phase II portion of the study are stratified by institution and disease status (locally advanced disease vs large operable tumor).
- Phase I (completed as of 5/26/2010): Patients receive docetaxel IV over 1 hour on day 1 and oral lapatinib ditosylate once daily on days 1-21. Treatment repeats every 3 weeks for 4 courses. Two additional courses may be given at the discretion of the physician.
- Cohorts of 3-6 patients receive escalating doses of docetaxel and lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
- Phase I bridge step (completed as of 5/26/2010): Patients receive FEC chemotherapy comprising fluorouracil IV over 15 minutes, epirubicin hydrochloride IV over 60 minutes, and cyclophosphamide IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 3 courses. Patients also receive docetaxel and lapatinib ditosylate as in phase I at the MTD for up to 3 courses.
- Cohorts of 3-6 patients receive de-escalating doses of docetaxel and lapatinib ditosylate in combination with FEC chemotherapy until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.
- Phase II: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive docetaxel and lapatinib ditosylate at the MTD as in the bridge step of phase I followed by FEC chemotherapy.
- Arm II: Patients receive docetaxel IV over 60 minutes and trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15. Patients then receive FEC chemotherapy as in the bridge step of phase I. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive docetaxel IV over 60 minutes, lapatinib ditosylate at the MTD as in the bridge step of phase I, and trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15. Patients then receive FEC chemotherapy as in the bridge step of phase I. Treatment with docetaxel, lapatinib ditosylate, and trastuzumab repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
All patients then undergo surgery to remove the tumor. Patients may then receive trastuzumab every 3 weeks for 1 year.
Blood samples are collected at baseline and periodically during study for pharmacokinetic studies. Patients also undergo tumor biopsies at baseline and periodically during study for laboratory studies. Blood and tissue samples are analyzed by quantitative reverse transcriptase polymerase chain reaction for biomarker profiling (HER1-3, Akt 1-3, mTOR, RICTOR, RAPTOR, CCND1, p21, survivin, PTEN), immunohistochemistry, fluorescent in situ hybridization (TopoII, HER2), and proteomics.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for the phase II.
- Conditions
- Breast Cancer
- Being tested
- docetaxel+lapatinib, docetaxel + trastuzumab, docetaxel + trastuzumab + lapatinib
- Keywords
- inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel+lapatinibDrug
3 cycles of docetaxel (100 mg/m²) + lapatinib (1000 mg/d) followed by 3 cycles of FEC
docetaxel + trastuzumabDrug
3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule followed by 3 cycles of FEC 100
docetaxel + trastuzumab + lapatinibDrug
3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule
+lapatinib (1000 mg/d) followed by 3 cycles of FEC 100
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Other | Not described Receives: Drug: docetaxel+lapatinib |
| arm 2 | Other | Not described Receives: Drug: docetaxel + trastuzumab |
| arm 3 | Experimental | Not described Receives: Drug: docetaxel + trastuzumab + lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I part: Dose limiting toxicity during cycle 1
Measured: during study
Phase II: Pathological complete response rate
Measured: end of study
Secondary outcomes (2)
Phase I: Changes in apoptosis and proliferation markers.
Measured: end of Phase I
Phase II: Tolerability, clinical/radiological response rates, breast conserving surgery, pharmacodynamics data
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- David Cameron, MD, Study chair, Edinburgh Cancer Centre at Western General HospitalHerve Bonnefoi, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450892
- Sponsor's protocol ID
- EORTC-10054
- Other IDs
- EORTC-10054, GSK-EORTC-10054, 2006-000864-94
- Status last verified
- Jul 2016
- First submitted
- 20 Mar 2007
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonnefoi H, Jacot W, Saghatchian M, Moldovan C, Venat-Bouvet L, Zaman K, Matos E, Petit T, Bodmer A, Quenel-Tueux N, Chakiba C, Vuylsteke P, Jerusalem G, Brain E, Tredan O, Messina CG, Slaets L, Cameron D. Neoadjuvant treatment with docetaxel plus lapatinib, trastuzumab, or both followed by an anthracycline-based chemotherapy in HER2-positive breast cancer: results of the randomised phase II EORTC 10054 study. Ann Oncol. 2015 Feb;26(2):325-32. doi: 10.1093/annonc/mdu551. Epub 2014 Dec 1.
PubMed 25467016Bonnefoi H, Zaman K, Debled M, Fiche M, Fournier M, Nobahar M, Pierga JY, Koch KM, Bartlett J, Zimmer A, Marreaud S, Bogaerts J, Cameron D. An European Organisation for Research and Treatment of Cancer phase I study of lapatinib and docetaxel as neoadjuvant treatment for human epidermal growth factor receptor 2 (HER2) positive locally-advanced/inflammatory or large operable breast cancer. Eur J Cancer. 2013 Jan;49(2):281-9. doi: 10.1016/j.ejca.2012.08.006. Epub 2012 Sep 18.
PubMed 22999386
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Lapatinib and Docetaxel as Neoadjuvant Treatment for HER-2 Positive Locally Advanced/Inflammatory or Large Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00450892
- Acronym / sponsor ID
- EORTC-10054
- Conditions
- Breast Cancer
- Keywords
- inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Mar 2007 (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.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of neoadjuvant therapy comprising docetaxel and lapatinib ditosylate before or after fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC chemotherapy) in patients with HER2-positive locally advanced, inflammatory, or large resectable breast cancer. (Phase I)
- Determine the safety of this regimen in these patients. (Phase I)
- Determine the pathological complete response rate in patients treated with neoadjuvant docetaxel and lapatinib ditosylate followed by FEC chemotherapy, and with neoadjuvant docetaxel and trastuzumab (Herceptin®) followed by FEC chemotherapy. (Phase II)
Secondary
- Determine the biological activity (i.e., changes in apoptosis and proliferation markers [PTEN mutation and function, pAkt, mTOR, and associated proteins]) of neoadjuvant docetaxel and lapatinib ditosylate in these patients. (Phase I)
- Determine adverse events or biological modifications. (Phase I)
- Determine the tolerability of these regimens in these patients. (Phase II)
- Determine the clinical activity of these regimens. (Phase II)
- Identify genes that may predict response in patients treated with docetaxel and lapatinib ditosylate. (Phase II)
OUTLINE: This is a multicenter, open-label, phase I dose-escalation study of docetaxel and lapatinib ditosylate followed by a randomized phase II study. Patients enrolled in the phase II portion of the study are stratified by institution and disease status (locally advanced disease vs large operable tumor).
- Phase I (completed as of 5/26/2010): Patients receive docetaxel IV over 1 hour on day 1 and oral lapatinib ditosylate once daily on days 1-21. Treatment repeats every 3 weeks for 4 courses. Two additional courses may be given at the discretion of the physician.
- Cohorts of 3-6 patients receive escalating doses of docetaxel and lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
- Phase I bridge step (completed as of 5/26/2010): Patients receive FEC chemotherapy comprising fluorouracil IV over 15 minutes, epirubicin hydrochloride IV over 60 minutes, and cyclophosphamide IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 3 courses. Patients also receive docetaxel and lapatinib ditosylate as in phase I at the MTD for up to 3 courses.
- Cohorts of 3-6 patients receive de-escalating doses of docetaxel and lapatinib ditosylate in combination with FEC chemotherapy until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.
- Phase II: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive docetaxel and lapatinib ditosylate at the MTD as in the bridge step of phase I followed by FEC chemotherapy.
- Arm II: Patients receive docetaxel IV over 60 minutes and trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15. Patients then receive FEC chemotherapy as in the bridge step of phase I. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive docetaxel IV over 60 minutes, lapatinib ditosylate at the MTD as in the bridge step of phase I, and trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15. Patients then receive FEC chemotherapy as in the bridge step of phase I. Treatment with docetaxel, lapatinib ditosylate, and trastuzumab repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
All patients then undergo surgery to remove the tumor. Patients may then receive trastuzumab every 3 weeks for 1 year.
Blood samples are collected at baseline and periodically during study for pharmacokinetic studies. Patients also undergo tumor biopsies at baseline and periodically during study for laboratory studies. Blood and tissue samples are analyzed by quantitative reverse transcriptase polymerase chain reaction for biomarker profiling (HER1-3, Akt 1-3, mTOR, RICTOR, RAPTOR, CCND1, p21, survivin, PTEN), immunohistochemistry, fluorescent in situ hybridization (TopoII, HER2), and proteomics.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for the phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Other | Drug: docetaxel+lapatinib |
| arm 2 | Other | Drug: docetaxel + trastuzumab |
| arm 3 | Experimental | Drug: docetaxel + trastuzumab + lapatinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| docetaxel+lapatinib3 cycles of docetaxel (100 mg/m²) + lapatinib (1000 mg/d) followed by 3 cycles of FEC | Drug | arm 1 |
| docetaxel + trastuzumab3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule followed by 3 cycles of FEC 100 | Drug | arm 2 |
| docetaxel + trastuzumab + lapatinib3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule +lapatinib (1000 mg/d) followed by 3 cycles of FEC 100 | Drug | arm 3 |
Primary outcome
Phase I part: Dose limiting toxicity during cycle 1
Time frame: during study
Phase II: Pathological complete response rate
Time frame: end of study
2 secondary outcomes
Phase I: Changes in apoptosis and proliferation markers.
Time frame: end of Phase I
Phase II: Tolerability, clinical/radiological response rates, breast conserving surgery, pharmacodynamics data
Time frame: end of study
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 7 Jul 2016.
- Results publication: PubMed 25467016Bonnefoi H, Jacot W, Saghatchian M, Moldovan C, Venat-Bouvet L, Zaman K, Matos E, Petit T, Bodmer A, Quenel-Tueux N, Chakiba C, Vuylsteke P, Jerusalem G, Brain E, Tredan O, Messina CG, Slaets L, Cameron D. Neoadjuvant treatment with docetaxel plus lapatinib, trastuzumab, or both followed by an anthracycline-based chemotherapy in HER2-positive breast cancer: results of the randomised phase II EORTC 10054 study. Ann Oncol. 2015 Feb;26(2):325-32. doi: 10.1093/annonc/mdu551. Epub 2014 Dec 1.
- Results publication: PubMed 22999386Bonnefoi H, Zaman K, Debled M, Fiche M, Fournier M, Nobahar M, Pierga JY, Koch KM, Bartlett J, Zimmer A, Marreaud S, Bogaerts J, Cameron D. An European Organisation for Research and Treatment of Cancer phase I study of lapatinib and docetaxel as neoadjuvant treatment for human epidermal growth factor receptor 2 (HER2) positive locally-advanced/inflammatory or large operable breast cancer. Eur J Cancer. 2013 Jan;49(2):281-9. doi: 10.1016/j.ejca.2012.08.006. Epub 2012 Sep 18.
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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.
David Cameron, MD study chair
Edinburgh Cancer Centre at Western General Hospital
Herve Bonnefoi, MD study chair
Institut Bergonié
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing docetaxel+lapatinib, docetaxel + trastuzumab and docetaxel + trastuzumab + lapatinib in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 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?
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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Belgium, Switzerland, Slovenia, United Kingdom. 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?
Phase I part: Dose limiting toxicity during cycle 1 (time frame: during study). 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?
On the ClinicalTrials.gov record for NCT00450892, which also lists 2 linked publications.
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 7 Jul 2016.