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Neoplasms, BreastPhase 3NCT00281658

Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2

A Phase 3 study testing Lapatinib (GW572016) oral tablets and Paclitaxel infusion in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 54 sites in 8 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 was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Breast
What is being tested?
Lapatinib (GW572016) oral tablets and Paclitaxel infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
444 participants
Where
54 sitesin 8 countries
Study dates
2 Jan 2006to 23 Nov 2021
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent;
  • Male or female ≥18 years;
  • Histologically confirmed invasive breast cancer with stage IV disease; If the disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.
  • Documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue by the central laboratory for randomization into the study;
  • If a taxane was administered in the neoadjuvant or adjuvant setting, progression must have occurred >12 months after completion of this treatment and the patient recovered from all associated toxicities;
  • Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors);
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  • Radiotherapy as palliative treatment for painful metastatic disease is permitted but must have been stopped within 2 weeks prior to initiation of any investigational treatment. All subjects must have recovered from all radiotherapy related toxicities prior to initiation of any investigational treatment. The site of radiotherapy must not be used as a site of measurable disease;
  • Bisphosphonate therapy for bone metastases and is allowed; however, treatment must be initiated prior to the first dose of investigational treatment. Prophylactic use of bisphosphonates in subjects without bone disease is not permitted, except for the treatment of osteoporosis;
  • For those patients whose disease is ER+ and/or PR+ the following criteria should be met:
  • Patients with visceral disease that requires chemotherapy (eg., patients with liver or lung metastases) Rapidly progressing or life threatening disease, as determined by the investigator Patients who received hormonal therapy and are no longer benefiting from this therapy and the hormonal treatment must have been stopped before the first dose of investigational treatment;
  • 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;
  • ECOG Performance Status of 0 to 1;
  • Life expectancy of ≥ 12 weeks;
  • Able to swallow and retain oral medication;
  • Archived tumor tissue available for testing;
  • Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study;
  • Willing to complete all screening assessments as outlined in the protocol;
  • Adequate organ function as defined in Table 1 Baseline Laboratory Values;

Who cannot join

  • Pregnant or lactating females at anytime during the study
  • Subjects with only non-measurable metastatic sites of disease per RECIST, (e.g. bone metastases, pleural effusion, or ascites, etc. (Refer to Section 5.3 Efficacy for list sites considered to be non-measurable disease.);
  • Received prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for metastatic disease.
  • Prior therapy with an ErbB1 and/or ErbB2 inhibitor, other than trastuzumab in the adjuvant setting. If trastuzumab was administered in the adjuvant setting, then > 12 months must have elapsed since completion of trastuzumab therapy;
  • Planned concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment;
  • Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
Show all 18Show fewer
  • Peripheral neuropathy of Grade 2 or greater;
  • 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;
  • 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 central nervous system (CNS) metastases or leptomeningeal carcinomatosis;
  • Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines;
  • Concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents;
  • Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational treatment;
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel or lapatinib or their excipients.

Trial locations and contacts

54 sites in 8 countries.

54 sites in 8 countries

China25 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100036

  • Novartis Investigative Site

    Beijing, 100071

  • Novartis Investigative Site

    Beijing, 100853

  • Novartis Investigative Site

    Chengdu, 610041

  • Novartis Investigative Site

    Chongqing, 400037

  • Novartis Investigative Site

    Dalian, Liaoning, 116027

  • Novartis Investigative Site

    Dalian, 116011

  • Novartis Investigative Site

    Fuzhou, 350001

  • Novartis Investigative Site

    Fuzhou, 350014

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510060

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022

  • Novartis Investigative Site

    Jinan, Shandong, 250012

  • Novartis Investigative Site

    Jinan, Shandong, 250031

  • Novartis Investigative Site

    Jinan, Shandong, 250117

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210002

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200070

  • Novartis Investigative Site

    Shanghai, 200433

  • Novartis Investigative Site

    Shenyang, 110015

  • Novartis Investigative Site

    Tianjin, 300060

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

  • Novartis Investigative Site

    Xi'an, Shaanxi, 710032

  • Novartis Investigative Site

    Xi'an, Shaanxi, 710061

Other trials in China

Brazil9 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-281

  • Novartis Investigative Site

    Jaú, São Paulo, 17210-120

  • Novartis Investigative Site

    Natal, Rio Grande do Norte, 59075-740

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610 000

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40.050-410

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40285-001

  • Novartis Investigative Site

    Santo André, São Paulo, 09060-650

  • Novartis Investigative Site

    São Paulo, São Paulo, 01221-020

  • Novartis Investigative Site

    São Paulo, São Paulo, 03102-002

Other trials in Brazil

Russia7 sites

  • Novartis Investigative Site

    Kazan', 420029

  • Novartis Investigative Site

    Moscow, 117997

  • Novartis Investigative Site

    Moscow, 125101

  • Novartis Investigative Site

    Moscow, 143423

  • Novartis Investigative Site

    Rostov-on-Don, 344037

  • Novartis Investigative Site

    Samara, 443031

  • Novartis Investigative Site

    Voronezh, 394062

Other trials in Russia

Ukraine4 sites

  • Novartis Investigative Site

    Cherkasy, 18009

  • Novartis Investigative Site

    Chernihiv, 14029

  • Novartis Investigative Site

    Dnipropetrovsk, 49055

  • Novartis Investigative Site

    Zaporizhzhya, 69040

Other trials in Ukraine

Hong Kong3 sites

  • Novartis Investigative Site

    Kowloon

  • Novartis Investigative Site

    Pokfulam

  • Novartis Investigative Site

    Tuenmen

Other trials in Hong Kong

Pakistan3 sites

  • Novartis Investigative Site

    Lahore, 53400

  • Novartis Investigative Site

    Lahore, 54600

  • Novartis Investigative Site

    Lahore

Other trials in Pakistan

Thailand2 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Chiang Mai, 50200

Other trials in Thailand

Peru1 site

  • Novartis Investigative Site

    Lima, Lima 34

Other trials in Peru

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer

This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease.

Read the detailed description

Subjects were randomized to receive either Lapatinib (1500 mg once daily) + Paclitaxel (80 mg/m2 IV weekly for 3 weeks every 4 weeks) or Placebo (once daily) + Paclitaxel (80 mg/m2 IV weekly for 3 weeks every 4 weeks).

Subjects who progressed while on study and were on the placebo+paclitaxel arm were permitted to enter an extension phase of open label monotherapy therapy with lapatinib or open label combination therapy with lapatinib+paclitaxel and followed for response, progression and survival.

Based on the positive results in the primary analysis, Protocol Amendment 02 (dated 09 May 2011) discontinued further entry into the lapatinib monotherapy extension phase, and ongoing subjects taking placebo were permitted to replace it with open label lapatinib therapy (with or without continued paclitaxel therapy).

Following the primary Overall Survival (OS) analysis and subsequent implementation of Protocol Amendment 03, subjects who were still receiving active treatment entered the Long-term follow-up (LTFU) phase of the study. Reporting requirements in the LTFU phase were limited to Adverse events of special interest (AESI), Serious adverse events (SAEs) and pregnancy, and the subjects continued to receive treatment until the occurrence of unacceptable toxicity or disease progression (as determined by the investigator) or permanent withdrawal from treatment for any reason. Subjects who were no longer receiving active treatment were withdrawn from the study.

Being tested
Lapatinib (GW572016) oral tablets, Paclitaxel infusion, Placebo
Keywords
ErbB2 positive, human epidermal growth factor receptor 2 positive (Her2+), metastatic breast cancer, Fluorescence in situ hybridization (FISH) positive, Stage IV
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lapatinib (GW572016) oral tabletsDrug

    1500 mg oral daily continuously

  • Paclitaxel infusionDrug

    Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months

  • PlaceboDrug

    Paclitaxel Matching Placebo

Study groups in NCT00281658
Study groupRoleWhat they receive
Paclitaxel and Lapatinib (Blinded)ExperimentalPaclitaxel and Lapatinib (Blinded)
Receives: Drug: Lapatinib (GW572016) oral tablets; Drug: Paclitaxel infusion
Paclitaxel and Placebo (Blinded)Active comparatorPaclitaxel and Placebo (Blinded)
Receives: Drug: Paclitaxel infusion; Drug: Placebo
Open Label - Monotherapy (Extension Phase)OtherOpen Label - Monotherapy (Lapatinib)
Receives: Drug: Lapatinib (GW572016) oral tablets
Open Label - Combination Therapy (Extension Phase)OtherOpen Label - Combination Therapy (Lapatinib and Paclitaxel)
Receives: Drug: Lapatinib (GW572016) oral tablets; Drug: Paclitaxel infusion

What is being measured

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

  1. Overall Survival (OS) at 53 Months

    Overall Survival (OS) was defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.

    Measured: From date of randomization until date of death from any cause, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)

Secondary outcomes (12)

  1. Overall Survival (OS) at 190 Months

    Overall Survival (OS) was defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.

    Measured: From date of randomization until date of death from any cause, assessed up to 190 months (Final OS analysis cut-off date = 23-Nov-2021)

  2. Progression-free Survival (PFS) by Investigator Assessment

    Progression-free survival (PFS) during the randomized phase was defined as the interval of time (in months) between the date of randomization and the earlier of date of disease progression (radiological or clinical assessment of symptomatic progression), or date of death due to any cause.

    Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)

  3. Overall Response Rate (ORR) by Investigator Assessment

    Overall response rate (ORR) during the randomized phase was evaluated per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and defined as the percentage of subjects achieving either a Complete Response (CR) or a Partial Response (PR). Participants with unknown or missing responses were treated as non-responders.

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)

  4. Clinical Benefit Rate (CBR)

    Clinical benefit rate (CBR) was defined as the percentage of subjects with evidence of CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions], taking as reference the smallest sum LD since treatment start) of >=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.

    Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary analysis cut-off date = 18-Jun-2010)

  5. Duration of Response (DOR)

    For subjects who show CR or PR, duration of response (DOR) was defined to be the time from first documented evidence of PR or CR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase.

    Measured: From date of confirmed CR or PR until date of progression or date of death from any cause, whichever comes first, assessed up to 190 months (Final analysis cut-off date = 23-Nov-2021)

  6. Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72

    The original outcome measure to be analyzed was Time to response (TTR) during the randomized phase defined as the time from randomization until first documented evidence of PR or CR (whichever status was recorded first); however, data were presented as the number of participants with a response at each nominal visit. Responses were based on the investigator's assessment, and only participants with a confirmed CR or PR were included in this analysis.

    Measured: Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72

  7. Number of Tumors Evaluable for PIK3CA Mutations

    Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.

    Measured: Baseline

  8. Number of Participants With Tumors Evaluable for PTEN

    Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression.

    Measured: Baseline

  9. Predictive Effect of PIK3CA Mutations Status on Overall Response Rate (ORR)

    ORR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving either CR or PR. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)

  10. Predictive Effect of PTEN Low on Overall Response Rate (ORR)

    ORR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving either CR or PR. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression. Tumors scored IHC 0/1+ were considered PTEN low.

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)

  11. Predictive Effect of PIK3CA Mutations Status on Clinical Benefit Rate (CBR)

    CBR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving CR or PR or stable disease. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. A PIK3CA mutation test kit was used to assess mutation status on genomic deoxyribonucleic acid (DNA) isolated from tumor tissue.

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)

  12. Predictive Effect of PTEN Low on Clinical Benefit Rate (CBR)

    CBR was evaluated per RECIST v1.1 and defined as the percentage of subjects achieving CR or PR or stable disease. Phosphatidylinositol 3-kinase (PI3K) pathway deregulation (that is PIK3CA mutations and/or phosphatase and tensin homolog (PTEN) loss) was studied to evaluate the predictive and prognostic value of PIK3CA mutations and/or PTEN low in HER2-positive patients receiving first-line treatment with paclitaxel alone or in combination with lapatinib. Immunohistochemistry (IHC) staining in an analytically validated assay was used in the assessment of PTEN protein expression on tumor tissue. Staining intensity was allocated a score of 0, 1+, 2+ or 3+. Tumors scored IHC 0 were considered as exhibiting an absence of PTEN expression whereas those scored ICH 1+, 2+ or 3+ were considered as exhibiting any PTEN expression, being 3+ the highest expression. Tumors scored IHC 0/1+ were considered PTEN low.

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)

Timeline

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

  1. First posted25 Jan 2006 (estimated)
  2. Study start2 Jan 2006
  3. Primary completion18 Jun 2010
  4. Study completion23 Nov 2021

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
Double blind
Who is masked
Participant, Investigator
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281658
Sponsor's protocol ID
EGF104535
Other IDs
CLAP016A2302
Status last verified
Feb 2023
First submitted
23 Jan 2006
Last updated
10 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Xu B, Guan Z, Shen Z, Tong Z, Jiang Z, Yang J, DeSilvio M, Russo M, Leigh M, Ellis C. Association of phosphatase and tensin homolog low and phosphatidylinositol 3-kinase catalytic subunit alpha gene mutations on outcome in human epidermal growth factor receptor 2-positive metastatic breast cancer patients treated with first-line lapatinib plus paclitaxel or paclitaxel alone. Breast Cancer Res. 2014 Jul 24;16(4):405. doi: 10.1186/s13058-014-0405-y.

    PubMed 25056500

  • Guan Z, Xu B, DeSilvio ML, Shen Z, Arpornwirat W, Tong Z, Lorvidhaya V, Jiang Z, Yang J, Makhson A, Leung WL, Russo MW, Newstat B, Wang L, Chen G, Oliva C, Gomez H. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 2013 Jun 1;31(16):1947-53. doi: 10.1200/JCO.2011.40.5241. Epub 2013 Mar 18.

    PubMed 23509322

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapatinib (GW572016) oral tablets and Paclitaxel infusion in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 54 sites in 8 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 18 inclusion and 18 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in China, Brazil, Russia, Ukraine, Hong Kong and 3 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 1 Jun 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?

Overall Survival (OS) at 53 Months (time frame: From date of randomization until date of death from any cause, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010)). 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 NCT00281658, 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 10 Feb 2023.

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