Trial · NCT00667251
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
NCT00667251, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2014-06-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer. Trials, record NCT00667251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00667251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
- NCT number
- NCT00667251
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 652 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Breast Cancer
- Interventions
- trastuzumab, docetaxel, lapatinib ditosylate, paclitaxel
- First posted
- 2008-04-28
- Last updated
- 2025-03-21
- Other registries' IDs
- eudract:2007-004568-27
- Results first posted
- 2014-06-18
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) at the Time of Primary Results | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Progression Free Survival (PFS) at the Time of Final Analysis | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months | Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at the last PFS assessment before crossover. |
| Secondary | Overall Survival (OS) (IIT Population) | From date of randomization until date of death from any cause, assessed up approximately 165 months | Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover. |
| Secondary | Overall Survival (OS) (Central HER2+ Population) | From date of randomization until date of death from any cause, assessed up approximately 165 months | Overall Survival (OS) was defined as the time interval between the date of randomization and the date of death from any cause. Subjects who were still alive at the time of the final analysis or became lost to follow-up, were censored at their last contact date. Subjects who crossover the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at last known alive date prior to crossover. |
| Secondary | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects. |
| Secondary | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | The incidence of Central Nervous System (CNS) metastasis at first progression was defined as the ratio of the number of subjects with CNS metastasis at progression over the total number of subjects. |
| Secondary | Time to Central Nervous System (CNS) Metastasis (IIT Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover. |
| Secondary | Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Time to Central Nervous System (CNS) metastasis was defined as the time from randomization until disease progression where CNS metastasis was documented at the time of first breast cancer progression. Subjects who crossed over the treatment to Trastuzumab (TTax/T) after interim analysis, were censored at RECIST assessment prior to crossover. |
| Secondary | Overall Response Rate (ORR) (IIT Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: * Complete Response (CR): Disappearance of all target and non-target lesions. * Partial Response (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. * Overall Response (OR): CR + PR. |
| Secondary | Overall Response Rate (ORR) (Central HER2+ Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e., they were included in the denominator when calculating the percentages. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions and assessed by MRI: * Complete Response (CR): Disappearance of all target and non-target lesions. * Partial Response (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. * Overall Response (OR): CR + PR. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) at the Time of Primary Results | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | Intent-to-Treat (ITT) and centrally-confirmed HER2 positive populations | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) at the Time of Final Analysis | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months | Intent-to-Treat (ITT) and centrally-confirmed HER2 positive populations | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) (IIT Population) | From date of randomization until date of death from any cause, assessed up approximately 165 months | Intent-to-Treat (ITT) population | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Central HER2+ Population) | From date of randomization until date of death from any cause, assessed up approximately 165 months | Centrally-confirmed HER2 positive population. | Months | MEDIAN |
| SECONDARY | Incidence of Central Nervous System (CNS) Metastasis at First Progression (IIT Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Participants in the Intent-to-Treat (ITT) population with available data for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Central Nervous System (CNS) Metastasis at First Progression (Central HER2+ Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Participants in the centrally-confirmed HER2 positive population with available data for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Central Nervous System (CNS) Metastasis (IIT Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Participants in the Intent-to-Treat (ITT) population with available data for the outcome measure. | Months | MEDIAN |
| SECONDARY | Time to Central Nervous System (CNS) Metastasis (Central HER2+ Population) | From date of randomization to CNS metastases at time of first progression, assessed up approximately 45 months | Participants in the centrally-confirmed HER2 positive population with available data for the outcome measure. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) (IIT Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Intent-to-Treat (ITT) population. | Percentage of Participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) (Central HER2+ Population) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 45 months | Centrally-confirmed HER2 positive population. | Percentage of Participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group640
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) at the Time of Primary Results | Lapatinib (LTax/L) | Intent-to-Treat (ITT) population | 8.97 | Full Range 0.30 to 32.69 | Months |
| Progression Free Survival (PFS) at the Time of Primary Results | Trastuzumab (TTax/T) | Intent-to-Treat (ITT) population | 11.30 | Full Range 0.30 to 38.54 | Months |
| Progression Free Survival (PFS) at the Time of Primary Results | Lapatinib (LTax/L) | centrally-confirmed HER2 positive population | 9.13 | Full Range 0.30 to 32.69 | Months |
| Progression Free Survival (PFS) at the Time of Primary Results | Trastuzumab (TTax/T) | centrally-confirmed HER2 positive population | 13.63 | Full Range 0.30 to 38.54 | Months |
| Progression Free Survival (PFS) at the Time of Final Analysis | Lapatinib (LTax/L) | Intent-to-Treat (ITT) population | 9.1 | Full Range 8.5 to 10.8 | Months |
| Progression Free Survival (PFS) at the Time of Final Analysis | Trastuzumab (TTax/T) | Intent-to-Treat (ITT) population | 11.5 | Full Range 10.9 to 13.8 | Months |
| Progression Free Survival (PFS) at the Time of Final Analysis | Lapatinib (LTax/L) | centrally-confirmed HER2 positive population | 9.4 | Full Range 8.5 to 11.0 | Months |
| Progression Free Survival (PFS) at the Time of Final Analysis | Trastuzumab (TTax/T) | centrally-confirmed HER2 positive population | 13.8 | Full Range 11.2 to 14.2 | Months |
| Overall Survival (OS) (IIT Population) | Lapatinib (LTax/L) | 30.0 | 95% Confidence Interval 24.2 to NA | Months | |
| Overall Survival (OS) (IIT Population) | Trastuzumab (TTax/T) | 38.3 | 95% Confidence Interval 31.0 to NA | Months |
1 to 10 of 640Source ClinicalTrials.gov
See all 640 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lapatinib (LTax/L) | 326 | |
| Overall Study | STARTED | Trastuzumab (TTax/T) | 326 | |
| Overall Study | Randomized Not Treated | Lapatinib (LTax/L) | 4 | |
| Overall Study | Randomized Not Treated | Trastuzumab (TTax/T) | 1 | |
| Overall Study | Crossed Over to Ttax/T After IA Results | Lapatinib (LTax/L) | 5 | |
| Overall Study | Crossed Over to Ttax/T After IA Results | Trastuzumab (TTax/T) | 0 | |
| Overall Study | Central HER2 Positive | Lapatinib (LTax/L) | 270 | |
| Overall Study | Central HER2 Positive | Trastuzumab (TTax/T) | 267 | |
| Overall Study | Safety Population | Lapatinib (LTax/L) | 322 | |
| Overall Study | Safety Population | Trastuzumab (TTax/T) | 325 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,056
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 | Chest pain | Cardiac disorders | Lapatinib (LTax/L) - All Participants | 9 | 322 | |
| other | Chest pain | Cardiac disorders | Trastuzumab (TTax/T) | 21 | 325 | |
| other | Chest pain | Cardiac disorders | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results | 0 | 5 | |
| other | Chest pain | Cardiac disorders | Lapatinib (LTax/L) - All Participants (Post-treatment) | 0 | ||
| other | Chest pain | Cardiac disorders | Trastuzumab (TTax/T) (Post-treatment) | 0 | ||
| other | Chest pain | Cardiac disorders | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results (Post-treatment) | 0 | ||
| other | Left ventricular dysfunction | Cardiac disorders | Lapatinib (LTax/L) - All Participants | 9 | 322 | |
| other | Left ventricular dysfunction | Cardiac disorders | Trastuzumab (TTax/T) | 25 | 325 | |
| other | Left ventricular dysfunction | Cardiac disorders | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results | 0 | 5 | |
| other | Left ventricular dysfunction | Cardiac disorders | Lapatinib (LTax/L) - All Participants (Post-treatment) | 0 |
1 to 10 of 1,056Source ClinicalTrials.gov
See all 1,056 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib (LTax/L) - All Participants | 21 | 326 |
| Total, all-cause mortality | Trastuzumab (TTax/T) | 13 | 326 |
| Total, all-cause mortality | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results | 0 | 5 |
| Total, all-cause mortality | Lapatinib (LTax/L) - All Participants (Post-treatment) | 82 | 301 |
| Total, all-cause mortality | Trastuzumab (TTax/T) (Post-treatment) | 73 | 312 |
| Total, all-cause mortality | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results (Post-treatment) | 0 | 5 |
| Total, other adverse events | Lapatinib (LTax/L) - All Participants | 316 | 322 |
| Total, other adverse events | Trastuzumab (TTax/T) | 319 | 325 |
| Total, other adverse events | Lapatinib (LTax/L) - Crossed Over to Trastuzumab (TTax/T) After IA Results | 1 | 5 |
| Total, other adverse events | Lapatinib (LTax/L) - All Participants (Post-treatment) | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00667251
GET https://conductscience.org/api/trials/v1/NCT00667251/registered?page=2