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Neoplasms, BreastPhase 3NCT00320385

Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

A Phase 3 study testing Lapatinib and Trastuzumab in people with Neoplasms, Breast, run by GlaxoSmithKline at 145 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
Lapatinib and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
296 participants
Where
145 sitesin 13 countries
Study dates
Nov 2005to Oct 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed informed consent.
  • Female ≥18 years. Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product.
  • Metastatic breast cancer, histologically/cytologically confirmed. If the disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology.
  • Subjects must have stage IV breast cancer whereby their disease has progressed in either the adjuvant or metastatic setting. Prior therapies must include, but are not limited to:
  • Taxane-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on taxane.
  • Anthracycline-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on anthracycline.
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  • Subjects must have documented progression following at least ONE trastuzumab plus cytotoxic chemotherapy or anti-hormonal regimen in the metastatic setting.
  • Note: The most recent treatment must have contained trastuzumab, either alone or in combination with other therapy in the metastatic setting, and subjects must have progressed while on this regimen. Progression is defined as either new lesions or a ≥20% increase in the sum of longest diameter (LD) on the progression radiologic scan.
  • Subjects must have archived tumor tissue available for testing.
  • Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by IHC in primary or metastatic tumor tissue. The IHC or FISH amplification may be documented by a local or central laboratory for randomization into the study. Subjects may be randomized on the basis of ErbB2 positivity by IHC 3+ overexpression or FISH amplification.
  • Lesion eligibility is as follows:
  • at least one measurable lesion(s) according to Response Evaluation Criteria in Solid Tumors [RECIST; Therasse, 2000], or
  • bone-only disease.
  • Note: Tumor lesions which are situated in a previously irradiated field, and have well-defined margins which are located in soft tissue will be defined as measurable disease.
  • Subjects with stable CNS metastases defined as asymptomatic and off systemic steroids and anticonvulsants for at least 1 month. Treatment with prophylactic anticonvulsants is permitted, unless listed within the Prohibited Medications (Section 8.2).
  • Radiotherapy if received within 2 weeks prior to initiation of investigational product to a limited area (e.g., palliative treatment for painful disease) other than the sole site of measurable disease is allowed; however, subject must have completed treatment and recovered from all treatment-related toxicities prior to administration of the first dose of investigational product.
  • With the single exception of prior trastuzumab treatment, all prior chemotherapy, immunotherapy, biologic therapy, or surgery (except for minor surgical procedures) must be discontinued at least 3 weeks prior to the first dose of investigational product. Subjects must have recovered or stabilized sufficiently from treatment-related toxicities prior to administration of the first dose of investigational product.
  • Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of investigational product. Prophylactic use of bisphosphonates is permitted only for the treatment of osteoporosis.
  • ECOG Performance Status of 0 to 2.
  • Able to swallow and retain oral medication.
  • Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive. Same modality used at baseline must be used for repeat assessments throughout study.
  • Subject must have adequate organ function as defined in Table 1 :
  • Table 1 (Definitions for Adequate Hematologic and Hepatic Function)
  • SYSTEM (LABORATORY VALUES)
  • Hematologic:
  • ANC (absolute neutrophil count) (≥ 1x10^9/ L)
  • Hemoglobin (≥ 9 g / dL)
  • Platelets (≥75x10^9/ L)
  • Hepatic
  • Albumin (≥ 2.5 g / dL)
  • Serum bilirubin (≤ 2 mg / dL)
  • AST and ALT (≤ 3 x ULN without liver metastases) (≤ 5 xULN if documented liver metastases)
  • Renal
  • Serum Creatinine (≤1.5 mg / dL)
  • OR -
  • Calculated Creatinine Clearance1 (≥40 mL / min)
  • Calculated by the Cockcroft and Gault Method.
  • Subjects may continue anti-estrogen therapy only if treatment was initiated at least 1 month prior to the first dose of investigational product (IP). After randomization, no anti-hormonal therapy may be initiated.

Who cannot join

  • Pregnant or lactating females.
  • Prior therapy with an ErbB1 and/or ErbB2 inhibitor other than trastuzumab.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.
  • History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
  • Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
Show all 15Show fewer
  • Active or uncontrolled infection.
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
  • Known history or clinical evidence of leptomeningeal carcinomatosis.
  • Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy).
  • Concurrent treatment with an investigational agent or participation in another clinical trial.
  • Used an investigational drug within 3 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational product.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or their excipients.
  • 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).

Trial locations and contacts

145 sites in 13 countries.

145 sites in 13 countries

United States87 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Arlington, Texas, 76014

  • GSK Investigational Site

    Austin, Texas, 78731

  • GSK Investigational Site

    Beaumont, Texas, 77702-1449

  • GSK Investigational Site

    Bedford, Texas, 76022

  • GSK Investigational Site

    Boca Raton, Florida, 33428

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Bryn Mawr, Pennsylvania, 19010

  • GSK Investigational Site

    Canton, Ohio, 44710

  • GSK Investigational Site

    Cary, North Carolina, 27511

  • GSK Investigational Site

    Cedar Rapids, Iowa, 52403

  • GSK Investigational Site

    Charlotte, North Carolina, 28203

  • GSK Investigational Site

    Columbia, Missouri, 65201

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75237

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Denton, Texas, 76210

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Edmonds, Washington, 98026

  • GSK Investigational Site

    El Paso, Texas, 79915

  • GSK Investigational Site

    Fort Myers, Florida, 33916

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fredericksburg, Texas, 78624

  • GSK Investigational Site

    Gainesville, Florida, 32605

  • GSK Investigational Site

    Green Bay, Wisconsin, 54301

  • GSK Investigational Site

    Greenville, South Carolina, 29605

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hickory, North Carolina, 28602

  • GSK Investigational Site

    Highland, California, 92346

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Indianapolis, Indiana, 46227

  • GSK Investigational Site

    Jacksonville, Florida, 32256

  • GSK Investigational Site

    Kansas City, Kansas, 66103

  • GSK Investigational Site

    Kettering, Ohio, 45409

  • GSK Investigational Site

    Kingston, Pennsylvania, 18704

  • GSK Investigational Site

    Las Vegas, Nevada, 89109

  • GSK Investigational Site

    Las Vegas, Nevada, 89135

  • GSK Investigational Site

    Lawrenceville, Georgia, 30046-7650

  • GSK Investigational Site

    Lewisville, Texas, 75067

  • GSK Investigational Site

    Longview, Texas, 75601

  • GSK Investigational Site

    McAllen, Texas, 78503-1298

  • GSK Investigational Site

    Mesquite, Texas, 75150

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Midland, Texas, 79701

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

  • GSK Investigational Site

    Montclair, New Jersey, 07042

  • GSK Investigational Site

    Morristown, New Jersey, 07962

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Brunswick, New Jersey, 08901

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Newark, Delaware, 19713

  • GSK Investigational Site

    Niles, Illinois, 60714

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Ocala, Florida, 34474

  • GSK Investigational Site

    Ocoee, Florida, 34761

  • GSK Investigational Site

    Odessa, Texas, 79761

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Overland Park, Kansas, 66210

  • GSK Investigational Site

    Paris, Texas, 75460

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Phoenix, Arizona, 85012

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Richmond, Virginia, 23230

  • GSK Investigational Site

    Robbinsdale, Minnesota, 55422

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    Saint Joseph, Missouri, 64507

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Francisco, California, 94115-1710

  • GSK Investigational Site

    Santa Rosa, California, 95403-1757

  • GSK Investigational Site

    Seattle, Washington, 98133

  • GSK Investigational Site

    Sedona, Arizona, 86336

  • GSK Investigational Site

    Spokane, Washington, 99202

  • GSK Investigational Site

    Summit, New Jersey, 07901

  • GSK Investigational Site

    Terre Haute, Indiana, 47802

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136-1902

  • GSK Investigational Site

    Tyler, Texas, 75702

  • GSK Investigational Site

    Vallejo, California, 94589

  • GSK Investigational Site

    Vancouver, Washington, 98684

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08043

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    West Reading, Pennsylvania, 19611

  • GSK Investigational Site

    Yakima, Washington, 98902

Other trials in United States

Germany21 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Berlin, State of Berlin, 10367

  • GSK Investigational Site

    Berlin, State of Berlin, 12200

  • GSK Investigational Site

    Coburg, Bavaria, 96450

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Fürstenwalde, Brandenburg, 15517

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22081

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22457

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22767

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69115

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44623

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24103

  • GSK Investigational Site

    Leer, Lower Saxony, 26789

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39108

  • GSK Investigational Site

    Munich, Bavaria, 80331

  • GSK Investigational Site

    Saarbrücken, Saarland, 66113

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70190

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70199

  • GSK Investigational Site

    Troisdorf, North Rhine-Westphalia, 53840

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

Other trials in Germany

Italy6 sites

  • GSK Investigational Site

    Bari, Apulia, 70126

  • GSK Investigational Site

    Lecce, Apulia, 73100

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Ravenna, Emilia-Romagna, 48100

  • GSK Investigational Site

    Rome, Lazio, 00144

  • GSK Investigational Site

    Rozzano (MI), Lombardy, 20089

Other trials in Italy

Spain6 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Hospitalet de Llobregat (Barcelona), 08907

  • GSK Investigational Site

    Lleida, 25198

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38320

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

Poland5 sites

  • GSK Investigational Site

    Bialystok, 15-027

  • GSK Investigational Site

    Olsztyn, 10-226

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Warsaw, 02-781

  • GSK Investigational Site

    Wroclaw, 53-413

Other trials in Poland

Greece4 sites

  • GSK Investigational Site

    Athens, 115 22

  • GSK Investigational Site

    Athens, 13122

  • GSK Investigational Site

    Athens, 185 37

  • GSK Investigational Site

    Neo Faliro, 18547

Other trials in Greece

Canada3 sites

  • GSK Investigational Site

    Laval, Quebec, H7M 3L9

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

Other trials in Canada

Czechia3 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Prague, 150 08

  • GSK Investigational Site

    Prague, 180 00

Other trials in Czechia

United Kingdom3 sites

  • GSK Investigational Site

    Huddersfield, HD3 3EA

  • GSK Investigational Site

    Ipswich, IP4 5PD

  • GSK Investigational Site

    London, SE1 9RT

Other trials in United Kingdom

Austria2 sites

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Vienna, A-1090

Other trials in Austria

Bulgaria2 sites

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Sofia, 1572

Other trials in Bulgaria

Croatia2 sites

  • GSK Investigational Site

    Split, 21000

  • GSK Investigational Site

    Zagreb, 10 000

Other trials in Croatia

Finland1 site

  • GSK Investigational Site

    Tampere, 33520

Other trials in Finland

About this study

Official title: A Randomized, Multicenter, Open-Label, Phase III Study of Lapatinib in Combination With Trastuzumab Versus Lapatinib Monotherapy in Subjects With HER2-positive Metastatic Breast Cancer Whose Disease Has Progressed on Trastuzumab-Containing Regimens

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Being tested
Lapatinib, Trastuzumab
Keywords
lapatinib, GW572016, ErbB2, EGFR, ErbB1, MBC, FISH amplification, Metastatic Breast Cancer, dual tyrosine kinase inhibitor, Her-2/neu
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 Tyverb, Tykerb

    oral lapatinib once daily

  • TrastuzumabBiological

    Also called Herceptin

    IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose

Study groups in NCT00320385
Study groupRoleWhat they receive
Arm 1: Lapatinib plus TrastuzumabExperimentalLapatinib 1000mg once daily in combination with trastuzumab 4mg/kg loading dose followed by 2mg/kg weekly
Receives: Drug: Lapatinib; Biological: Trastuzumab
Arm 2: LapatinibExperimentalLapatinib 1500mg once daily
Receives: Drug: Lapatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.

    Measured: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)

Secondary outcomes (7)

  1. Overall Survival (OS)

    OS was defined as the time from randomization until death due to any cause. For participants who did not die, OS was censored at the time of last contact.

    Measured: Baseline to death or 30 days after last dose for the last participant (up to 216 weeks)

  2. Overall Tumor Response (OR)

    OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR was defined as the disappearance of all lesions (target and/or non-target). PR was defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.

    Measured: Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)

  3. Clinical Benefit Response (CBR)

    CBR: percentage of participants with confirmed CR or PR or stable disease (SD) for at least 24 weeks according to RECIST criteria. CR: disappearance of all lesions (target and/or non-target). PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference baseline sum LD, with non-target lesions not increased or absent. SD: neither had sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) in target lesions, taking as reference the smallest sum LD since treatment started; persistence of 1 or more non-target lesions.

    Measured: Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)

  4. Time to Response (TTR)

    TTR was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). TTR could not be analyzed because too few participants experienced a confirmed CR or PR.

    Measured: Baseline until first documented evidence of CR or PR or 30 days after last dose (up to 216 weeks)

  5. Duration of Response (DR)

    DR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the first documented evidence of CR or PR until the first documented sign of disease progression or death. Because of the low number of participants experiencing a confirmed response in both treatment arms, analysis for this outcome measure was not performed.

    Measured: Time from first documented evidence of CR or PR until the first documented sign of disease progression or death or 30 days after last dose (up to 216 weeks)

  6. Time to Progression (TTP)

    TTP was defined as the interval between the date of randomization and the earlier of the date of disease progression or death due to breast cancer. Because this outcome measure was confounded by death due to other causes and was similar to PFS, it was not analyzed.

    Measured: Baseline to disease progression or death or 30 days after last dose (up to 216 weeks)

  7. Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study

    Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144.

    Measured: Baseline, Week 4, Week 12, Week 16, Week 24, and conclusion or withdrawal from study (up to Week 108)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2007
  4. Study completionOct 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00320385
Sponsor's protocol ID
EGF104900
Status last verified
Apr 2015
First submitted
1 May 2006
Last updated
26 Feb 2016
Data monitoring committee
No

Publications

  • Wu Y, Amonkar MM, Sherrill BH, O'Shaughnessy J, Ellis C, Baselga J, Blackwell KL, Burstein HJ. Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer. Ann Oncol. 2011 Dec;22(12):2582-2590. doi: 10.1093/annonc/mdr014. Epub 2011 Mar 15.

    PubMed 21406472

  • Blackwell KL, Burstein HJ, Storniolo AM, Rugo HS, Sledge G, Aktan G, Ellis C, Florance A, Vukelja S, Bischoff J, Baselga J, O'Shaughnessy J. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study. J Clin Oncol. 2012 Jul 20;30(21):2585-92. doi: 10.1200/JCO.2011.35.6725. Epub 2012 Jun 11.

    PubMed 22689807

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapatinib and Trastuzumab in people with Neoplasms, Breast, run by GlaxoSmithKline at 145 sites in 13 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 38 inclusion and 15 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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Germany, Italy, Spain, Poland and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-Free Survival (PFS) (time frame: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)). 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 NCT00320385, 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 26 Feb 2016.

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