Trial · NCT00075270
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
NCT00075270, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer. Trials, record NCT00075270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075270
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
- NCT number
- NCT00075270
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 580 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms, Breast
- Interventions
- Paclitaxel, GW572016 (Lapatinib)
- First posted
- 2004-01-09
- Last updated
- 2015-05-06
- Results first posted
- 2014-03-31
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression as Evaluated by the Investigator | Randomization until the date of disease progression or death (average of 26 weeks) | Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used. |
| Primary | Time to Progression as Evaluated by the Independent Review Committee (IRC) | Randomization until the date of disease progression or death (average of 26 weeks) | Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used. |
| Secondary | Number of Participants With Tumor Response as Evaluated by the Investigator | Randomization until the date of disease progression or death (average of 26 weeks) | The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The Response Evaluation Criteria in Solid Tumors (RECIST) was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions. |
| Secondary | Number of Participants With Tumor Response as Evaluated by the Independent Review Committee | Randomization until the date of disease progression or death (average of 26 weeks) | The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The RECIST criteria was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions. |
| Secondary | Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator | Randomization until the date of disease progression or death (average of 26 weeks) | Percentage of participants. with CB is defined as the percentage of participants with evidence of CR (disappearance of all TLs and NTLs), PR (TLs: a \>=30% decrease in the sum of the LD, taking as a reference the Baseline sum LD; NTLs: persistence of \>=1 lesion), or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) for \>=6 months based on RECIST criteria. PD for TL: a \>=20% increase in the sum of the LD of TLs or the appearance of \>=1 new lesion. PD for NTLs: the appearance of \>=1 new lesion and/or unequivocal progression of existing NTLs. |
| Secondary | Number of Participants With a Response of CR or PR by the Indicated Study Week | Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72 | Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR (disappearance of all TLs and NTLs) or PR (for TLs: a \>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; for NTLs: the persistence of \>=1 lesion) (whichever status was recorded first). TTR data are displayed as the number of participants achieving a CR or PR by the indicated week. The investigator evaluated the TTR, and the analysis was based on responses confirmed at a repeat assessment, with the TTR taken as the first time the response was observed. |
| Secondary | Duration of Response (DOR) | From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks) | The investigator evaluated the DOR for the subset of participants who showed a CR (disappearance of all TLs and NTLs) or PR (TLs: a \>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; NTLs: persistence of \>=1 lesion). DOR is defined as the time from the first documented evidence of PR or CR until the first documented sign of PD (TL: a \>=20% increase in the sum of the LD of TLs or the appearance of \>=1 new lesion; NTL: the appearance of \>=1 new lesion and/or unequivocal progression of existing NTLs) or death due to breast cancer, if sooner. |
| Secondary | Progression-Free Survival (PFS) | Randomization until the date of disease progression or death (average of 26 weeks) | PFS is defined as the interval between the date of randomization and the earliest date of progression disease (PD) or death due to any cause, if sooner. For TLs, progressive disease is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. par., participants. |
| Secondary | Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS) | Randomization until the date of disease progression or death (average of 26 weeks) | PFS is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause, if sooner. Six months PFS is defined as PFS at six months from the time of randomization. Raw data for 6 months PFS are not available; thus, data are presented as the number of participants who progressed or died at or prior to 6 months. For TLs, progressive disease is defined asat least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. PFS was assessed in participants who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used. |
| Secondary | Overall Survival | Randomization until the date of death due to any cause (average of 24 months) | Overall survival is defined as the time from randomization until death due to any cause. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression as Evaluated by the Investigator | Randomization until the date of disease progression or death (average of 26 weeks) | Intent-to-Treat (ITT) Population: all randomized participants who had received at least one dose of randomized therapy (lapatinib or placebo) | weeks | MEDIAN |
| PRIMARY | Time to Progression as Evaluated by the Independent Review Committee (IRC) | Randomization until the date of disease progression or death (average of 26 weeks) | ITT Population | weeks | MEDIAN |
| SECONDARY | Number of Participants With Tumor Response as Evaluated by the Investigator | Randomization until the date of disease progression or death (average of 26 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Tumor Response as Evaluated by the Independent Review Committee | Randomization until the date of disease progression or death (average of 26 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator | Randomization until the date of disease progression or death (average of 26 weeks) | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With a Response of CR or PR by the Indicated Study Week | Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72 | ITT Population | participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks) | ITT Population. Only participants who had a CR or PR were evaluated. | weeks | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Randomization until the date of disease progression or death (average of 26 weeks) | ITT Population. PFS was assessed in par. who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored par. (those without a documented date of disease progression/death due to any cause), the date of the last radiographic assessment was used. | weeks | MEDIAN |
| SECONDARY | Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS) | Randomization until the date of disease progression or death (average of 26 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Overall Survival | Randomization until the date of death due to any cause (average of 24 months) | ITT population. Overall survival was assessed in participants who died as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those still alive), the date of the last contact was used. | months | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression as Evaluated by the Investigator | Lapatinib With Paclitaxel | 29.0 | Inter-Quartile Range 13.9 to 46.9 | weeks | |
| Time to Progression as Evaluated by the Investigator | Placebo With Paclitaxel | 22.9 | Inter-Quartile Range 12.0 to 38.3 | weeks | |
| Time to Progression as Evaluated by the Independent Review Committee (IRC) | Lapatinib With Paclitaxel | 33.7 | Inter-Quartile Range 18.7 to 69.1 | weeks | |
| Time to Progression as Evaluated by the Independent Review Committee (IRC) | Placebo With Paclitaxel | 26.1 | Inter-Quartile Range 12.9 to 57.1 | weeks | |
| Number of Participants With Tumor Response as Evaluated by the Investigator | Lapatinib With Paclitaxel | CR | 14 | participants | |
| Number of Participants With Tumor Response as Evaluated by the Investigator | Placebo With Paclitaxel | CR | 6 | participants | |
| Number of Participants With Tumor Response as Evaluated by the Investigator | Lapatinib With Paclitaxel | PR | 88 | participants | |
| Number of Participants With Tumor Response as Evaluated by the Investigator | Placebo With Paclitaxel | PR | 67 | participants | |
| Number of Participants With Tumor Response as Evaluated by the Independent Review Committee | Lapatinib With Paclitaxel | CR | 1 | participants | |
| Number of Participants With Tumor Response as Evaluated by the Independent Review Committee | Placebo With Paclitaxel | CR | 1 | participants |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lapatinib With Paclitaxel | 291 | |
| Overall Study | STARTED | Placebo With Paclitaxel | 288 | |
| Overall Study | Missing | Lapatinib With Paclitaxel | 26 | |
| Overall Study | Missing | Placebo With Paclitaxel | 13 | |
| Overall Study | COMPLETED | Lapatinib With Paclitaxel | 5 | |
| Overall Study | COMPLETED | Placebo With Paclitaxel | 4 | |
| Overall Study | NOT COMPLETED | Lapatinib With Paclitaxel | 286 | |
| Overall Study | NOT COMPLETED | Placebo With Paclitaxel | 284 |
Source ClinicalTrials.gov
Adverse events1,194
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 | Alopecia | Skin and subcutaneous tissue disorders | Lapatinib With Paclitaxel | 153 | 293 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Placebo With Paclitaxel | 183 | 286 | |
| other | Rash | Skin and subcutaneous tissue disorders | Lapatinib With Paclitaxel | 145 | 293 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo With Paclitaxel | 66 | 286 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Lapatinib With Paclitaxel | 46 | 293 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo With Paclitaxel | 37 | 286 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Lapatinib With Paclitaxel | 13 | 293 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Placebo With Paclitaxel | 8 | 286 | |
| other | Nail disorder | Skin and subcutaneous tissue disorders | Lapatinib With Paclitaxel | 8 | 293 | |
| other | Nail disorder | Skin and subcutaneous tissue disorders | Placebo With Paclitaxel | 5 | 286 |
1 to 10 of 1,194Source ClinicalTrials.gov
See all 1,194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lapatinib With Paclitaxel | ||
| Total, all-cause mortality | Placebo With Paclitaxel | ||
| Total, other adverse events | Lapatinib With Paclitaxel | 287 | 293 |
| Total, other adverse events | Placebo With Paclitaxel | 278 | 286 |
| Total, serious adverse events | Lapatinib With Paclitaxel | 103 | 293 |
| Total, serious adverse events | Placebo With Paclitaxel | 63 | 286 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lapatinib With Paclitaxel vs Placebo With Paclitaxel: Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS) | Trial comparisons |
| Lapatinib With Paclitaxel vs Placebo With Paclitaxel: 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/NCT00075270
GET https://conductscience.org/api/trials/v1/NCT00075270/results?page=2