Trial · NCT00073528
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
NCT00073528, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-05-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer. Trials, record NCT00073528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00073528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
- NCT number
- NCT00073528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,286 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Breast Neoplasms
- Interventions
- Lapatinib, Letrozole, Placebo
- First posted
- 2003-11-26
- Last updated
- 2021-02-24
- Other registries' IDs
- eudract:2004-003928-35
- Results first posted
- 2012-05-17
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator | From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months | PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Primary | Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Secondary | Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Secondary | PFS in Participants in the ITT Population as Assessed by the Investigator | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months | PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Secondary | Overall Survival in the HER2-Positive Population | From date of randomization until date of death due to any cause, assessed up to 46 months | Overall survival was defined as the time from randomization until death due to any cause. |
| Secondary | Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | Up to 46 months | OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 \* (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. |
| Secondary | Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | Up to 46 months | Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval \[DI\] =\>6 months or DI \<6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date. |
| Secondary | Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator | Up to 46 months | CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement. |
| Secondary | Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator. | Up to 46 months | CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions. |
| Secondary | Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator. | Up to 46 months | CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator | From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months | HER2-Positive Population: all randomized participants who had documented amplification of baseline HER2 by fluorescence in situ hybridization (FISH) (=\>2.0) or 3+ immunohistochemistry (IHC) (or 2+ IHC and FISH +) in archived tumor tissue regardless of whether or not study treatment had been received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months | HER2-Positive Population. Only those participants who experienced disease progression or died during their participation in the study were assessed. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months | ITT Population: all randomized participants, regardless of whether or not study treatment had been received. The ITT Population included the HER2-Positive Population, the HER2-Negative Population, and the HER2-Missing Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PFS in Participants in the ITT Population as Assessed by the Investigator | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months | ITT Population. Only those participants who experienced disease progression or died during their participation in the study were assessed. | Weeks | MEDIAN |
| SECONDARY | Overall Survival in the HER2-Positive Population | From date of randomization until date of death due to any cause, assessed up to 46 months | HER2-Positive Population. Only those participants who died during the study due to any cause were assessed. | Weeks | MEDIAN |
| SECONDARY | Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | Up to 46 months | HER2-Positive Population | Percent response rate | NUMBER |
| SECONDARY | Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator | Up to 46 months | HER2-Positive Population. Only those participants with measurable disease, including bone scans, were assessed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator | Up to 46 months | HER2-Positive Population | Months | NUMBER |
| SECONDARY | Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator. | Up to 46 months | HER2-Positive Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator. | Up to 46 months | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group202
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator | Placebo + Letrozole 2.5 mg | 89 | Participants | ||
| Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator | Lapatinib 1500 mg + Letrozole 2.5 mg | 88 | Participants | ||
| Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator | Placebo + Letrozole 2.5 mg | 13.0 | 95% Confidence Interval 12.0 to 23.7 | Weeks | |
| Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator | Lapatinib 1500 mg + Letrozole 2.5 mg | 35.4 | 95% Confidence Interval 24.1 to 39.4 | Weeks | |
| Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator | Placebo + Letrozole 2.5 mg | 476 | Participants | ||
| Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator | Lapatinib 1500 mg + Letrozole 2.5 mg | 413 | Participants | ||
| PFS in Participants in the ITT Population as Assessed by the Investigator | Placebo + Letrozole 2.5 mg | 47.0 | 95% Confidence Interval 36.9 to 50.9 | Weeks | |
| PFS in Participants in the ITT Population as Assessed by the Investigator | Lapatinib 1500 mg + Letrozole 2.5 mg | 51.7 | 95% Confidence Interval 47.6 to 59.6 | Weeks | |
| Overall Survival in the HER2-Positive Population | Placebo + Letrozole 2.5 mg | 140.3 | 95% Confidence Interval 92.1 to 159.4 | Weeks | |
| Overall Survival in the HER2-Positive Population | Lapatinib 1500 mg + Letrozole 2.5 mg | 144.7 | 95% Confidence Interval 95.6 to NA | Weeks |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Letrozole 2.5 mg | 644 | |
| Overall Study | STARTED | Lapatinib 1500 mg + Letrozole 2.5 mg | 642 | |
| Overall Study | COMPLETED | Placebo + Letrozole 2.5 mg | 14 | |
| Overall Study | COMPLETED | Lapatinib 1500 mg + Letrozole 2.5 mg | 14 | |
| Overall Study | NOT COMPLETED | Placebo + Letrozole 2.5 mg | 630 | |
| Overall Study | NOT COMPLETED | Lapatinib 1500 mg + Letrozole 2.5 mg | 628 |
Source ClinicalTrials.gov
Adverse events530
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Letrozole 2.5 mg | 28 | 624 | |
| other | Anaemia | Blood and lymphatic system disorders | Lapatinib 1500 mg + Letrozole 2.5 mg | 52 | 654 | |
| other | Dyspnoea | Cardiac disorders | Placebo + Letrozole 2.5 mg | 68 | 624 | |
| other | Dyspnoea | Cardiac disorders | Lapatinib 1500 mg + Letrozole 2.5 mg | 58 | 654 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Letrozole 2.5 mg | 28 | 624 | |
| other | Abdominal pain | Gastrointestinal disorders | Lapatinib 1500 mg + Letrozole 2.5 mg | 48 | 654 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo + Letrozole 2.5 mg | 16 | 624 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Lapatinib 1500 mg + Letrozole 2.5 mg | 36 | 654 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Letrozole 2.5 mg | 64 | 624 | |
| other | Constipation | Gastrointestinal disorders | Lapatinib 1500 mg + Letrozole 2.5 mg | 45 | 654 |
1 to 10 of 530Source ClinicalTrials.gov
See all 530 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Letrozole 2.5 mg | 23 | 624 |
| Total, all-cause mortality | Lapatinib 1500 mg + Letrozole 2.5 mg | 18 | 654 |
| Total, other adverse events | Placebo + Letrozole 2.5 mg | 481 | 624 |
| Total, other adverse events | Lapatinib 1500 mg + Letrozole 2.5 mg | 589 | 654 |
| Total, serious adverse events | Placebo + Letrozole 2.5 mg | 103 | 624 |
| Total, serious adverse events | Lapatinib 1500 mg + Letrozole 2.5 mg | 150 | 654 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population | Trial comparisons |
| Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator | Trial comparisons |
Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator | Trial comparisons |
| Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: Number of Participants With Evidence of Brain Metastases From the ITT Population | Trial comparisons |
| Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: deaths from any cause | Trial comparisons |
| Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00073528
GET https://conductscience.org/api/trials/v1/NCT00073528/registered?page=2