Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Inflammatory Breast Neoplasms

Breast Diseases

Skin Diseases

Inflammatory Breast Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Lapatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

lapatinib

Pazopanib

GSK Clinical Trials

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib Versus Lapatinib Monotherapy in Patients With ErbB2 Over-expressing Inflammatory Breast Cancer

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.

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.

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.

GlaxoSmithKline

Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).

Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo

Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.

Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg

Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.

Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo

Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.

Cohort 2: Pazopanib 800 mg

Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.

Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg

Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.

Open-label Lapatinib 1500 mg

Total

Years

Age Continuous

Sex: Female, Male

African American/African Heritage

American Indian or Alaska Native

Central/South Asian Heritage

Japanese/East Asian /South East Asian Heritage

White

American Indian or Alaska Native and Asian

Race/Ethnicity, Customized

GSK Response Center

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.

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

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.

Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer	NCT00558103	Neoplasms, Brea...	lapatinib Pazopanib	18 Years -	GlaxoSmithKline
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer	NCT00558103	Neoplasms, Brea...	lapatinib Pazopanib	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for cutaneous disease