Trial · NCT00558103
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer
NCT00558103, Phase 2, Completed, GlaxoSmithKline; results first posted 2012-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer. Trials, record NCT00558103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00558103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer
- NCT number
- NCT00558103
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 163 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms, Breast
- Interventions
- lapatinib, Pazopanib
- First posted
- 2007-11-14
- Last updated
- 2013-02-04
- Results first posted
- 2012-07-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions | Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks | RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools. |
| Secondary | Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression | From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks | RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of \>=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools. |
| Secondary | Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease) | From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks | RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of \>=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools. |
| Secondary | Overall Survival | From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks | Overall survival is defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. |
Source ClinicalTrials.gov
Outcomes4
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 Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions | Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks | Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study treatment. The mITT1 Population was used for cohort 1; the mITT2 Population used for cohort 2. | participants | NUMBER |
| SECONDARY | Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression | From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks | mITT1 and mITT2 Populations. Only participants who achieved a response of CR or PR during the study were analyzed. For participants who did not progress or die, duration of response was censored on the date of the last adequate assessment. | weeks | MEDIAN |
| SECONDARY | Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease) | From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks | mITT1 and mITT2 Populations | weeks | MEDIAN |
| SECONDARY | Overall Survival | From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks | mITT1 and mITT2 Populations | months | MEDIAN |
Source ClinicalTrials.gov
Results by group20
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 Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | 11 | participants | ||
Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | 17 | participants | ||
Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | 17 | participants | ||
Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions | Cohort 2: Pazopanib 800 mg | 4 | participants | ||
Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions | Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg | 22 | participants | ||
| Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | 16.9 | 90% Confidence Interval 12.4 to 21.0 | weeks | |
| Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | 13.0 | 90% Confidence Interval 9.1 to 28.1 | weeks | |
| Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | 13.6 | 90% Confidence Interval 10.0 to 19.9 | weeks | |
| Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression | Cohort 2: Pazopanib 800 mg | 31.2 | 90% Confidence Interval 3.4 to 33.1 | weeks | |
| Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression | Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg | 12.7 | 90% Confidence Interval 8.0 to 16.1 | weeks |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Treatment Phase | STARTED | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | 38 | |
| Randomized Treatment Phase | STARTED | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | 38 | |
| Randomized Treatment Phase | STARTED | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | 36 | |
| Randomized Treatment Phase | STARTED | Cohort 2: Pazopanib 800 mg | 13 | |
| Randomized Treatment Phase | STARTED | Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg | 38 | |
| Randomized Treatment Phase | STARTED | Open-label Lapatinib 1500 mg | 0 | |
| Randomized Treatment Phase | COMPLETED | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | 33 | |
| Randomized Treatment Phase | COMPLETED | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | 34 | |
| Randomized Treatment Phase | COMPLETED | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | 33 | |
| Randomized Treatment Phase | COMPLETED | Cohort 2: Pazopanib 800 mg | 11 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events834
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 | Diarrhea | Gastrointestinal disorders | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | 15 | 38 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | 33 | 38 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | 20 | 36 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort 2: Pazopanib 800 mg | 6 | 13 | |
| other | Diarrhea | Gastrointestinal disorders | Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg | 22 | 38 | |
| other | Diarrhea | Gastrointestinal disorders | Open-label Lapatinib 1500 mg | 2 | 9 | |
| other | Nausea | Gastrointestinal disorders | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | 5 | 38 | |
| other | Nausea | Gastrointestinal disorders | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | 17 | 38 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | 6 | 36 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2: Pazopanib 800 mg | 2 | 13 |
1 to 10 of 834Source ClinicalTrials.gov
See all 834 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | ||
| Total, all-cause mortality | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | ||
| Total, all-cause mortality | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | ||
| Total, all-cause mortality | Cohort 2: Pazopanib 800 mg | ||
| Total, all-cause mortality | Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg | ||
| Total, all-cause mortality | Open-label Lapatinib 1500 mg | ||
| Total, other adverse events | Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo | 31 | 38 |
| Total, other adverse events | Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg | 37 | 38 |
| Total, other adverse events | Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo | 34 | 36 |
| Total, other adverse events | Cohort 2: Pazopanib 800 mg | 13 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00558103
GET https://conductscience.org/api/trials/v1/NCT00558103/flow?page=2