Trial Outcomes & Findings for Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China (NCT NCT00508274)
NCT ID: NCT00508274
Last Updated: 2021-09-21
Results Overview
CBR is defined by the percentage of participants achieving either a confirmed tumor response of complete response (CR) or partial response (PR) or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A "partial response" requires a decrease of 30% or more, "complete response" requires all target lesions disappear, "Progression" requires an increase of at least 20%, and "Stable disease" falls in between these two. All responses have a repeat assessment to confirm the response.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 90 months
Results posted on
2021-09-21
Participant Flow
Participant milestones
| Measure |
Lapatinib + Capecitabine
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Lapatinib + Capecitabine
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
7
|
|
Overall Study
Disease progression
|
32
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Subject received new anti-cancer chemotherapy/traditional Chinese medicine
|
2
|
|
Overall Study
Missing
|
3
|
Baseline Characteristics
Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China
Baseline characteristics by cohort
| Measure |
Lapatinib + Capecitabine
n=52 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 90 monthsPopulation: Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product
CBR is defined by the percentage of participants achieving either a confirmed tumor response of complete response (CR) or partial response (PR) or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A "partial response" requires a decrease of 30% or more, "complete response" requires all target lesions disappear, "Progression" requires an increase of at least 20%, and "Stable disease" falls in between these two. All responses have a repeat assessment to confirm the response.
Outcome measures
| Measure |
Lapatinib + Capecitabine
n=52 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
57.7 Percentage of participants
Interval 43.2 to 71.3
|
SECONDARY outcome
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 90.38 months.Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product
PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.
Outcome measures
| Measure |
Lapatinib + Capecitabine
n=52 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Progression-Free Survival (PFS)
|
6.34 Months
Interval 0.03 to 90.38
|
SECONDARY outcome
Timeframe: at Baseline and every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed up to 90.38 months, with 6 months PFS reported.Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product
Six Months Progression-Free Survival is defined as the percentage of surviving participants who are progression-free longer than six months (greather than 180 days) after the first start date of study treatment.
Outcome measures
| Measure |
Lapatinib + Capecitabine
n=52 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Six Months Progression-Free Survival
|
53.55 Percentage of participants
Interval 38.77 to 66.25
|
SECONDARY outcome
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 14.78 monthsPopulation: Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product. TTR only applied to participants for whom best overall response was complete response (CR) or partial response (PR) or stable disease.
Time to response is defined as the time from first dose date until first documentation of disease response. TTR only applied to participants for whom best overall response was complete response (CR), partial response (PR) or stable disease (SD). Participants who had not had a partial response, complete response or stable disease at the cut-off date for this endpoint analysis were censored for time to response.
Outcome measures
| Measure |
Lapatinib + Capecitabine
n=23 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Time to Response (TTR)
|
4.07 Months
Interval 2.73 to 14.78
|
SECONDARY outcome
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 88.80 months.Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product. DOR only applied to participants for whom best overall response is complete response (CR) or partial response (PR) or stable disease (SD).
Duration of response (complete response, partial response or stable disease) is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first. DOR only applied to participants for whom best overall response was complete response (CR), partial response (PR) or stable disease (SD). Participants who had not had a partial response, complete response or stable disease at the cut-off date for this endpoint analysis were censored for duration of response.
Outcome measures
| Measure |
Lapatinib + Capecitabine
n=23 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Duration of Response (DOR)
|
8.18 Months
Interval 2.69 to 88.8
|
SECONDARY outcome
Timeframe: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 90 monthsPopulation: Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product
Number of participants who had Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment.
Outcome measures
| Measure |
Lapatinib + Capecitabine
n=52 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Number of Participants With Central Nervous System (CNS) as First Site of Relapse
Participants with any site of relapse
|
17 participants
|
|
Number of Participants With Central Nervous System (CNS) as First Site of Relapse
Participants with CNS disease as first site of relapse
|
2 participants
|
POST_HOC outcome
Timeframe: up to 4276 days for Lapatinib/up to 3384 days for Capecitabine (on-treatment), approx. 12 years (all collected deaths)Population: Clinical Database Population: all treated participants
On treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 4276 days (treatment duration ranged from 13 - 4246 days) for Lapatinib and 3384 days (treatment duration ranged form 8 - 3354 days) for Capecitabine. Total deaths was collected from study start to study end (LPLV).
Outcome measures
| Measure |
Lapatinib + Capecitabine
n=52 Participants
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
All Collected Deaths
Total Deaths
|
11 Participants
|
|
All Collected Deaths
On-treatment Deaths
|
2 Participants
|
Adverse Events
Lapatinib + Capecitabine
Serious events: 4 serious events
Other events: 49 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lapatinib + Capecitabine
n=52 participants at risk
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
1/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
1.9%
1/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal Cancer Stage 0
|
1.9%
1/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
1/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
Lapatinib + Capecitabine
n=52 participants at risk
Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.5%
7/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
26/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Mouth Ulceration
|
11.5%
6/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
17.3%
9/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
9.6%
5/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Asthenia
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
25.0%
13/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
7.7%
4/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
38.5%
20/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Liver Injury
|
7.7%
4/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
7.7%
4/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.7%
4/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood Bilirubin Increased
|
9.6%
5/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Neutrophil Count Decreased
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
White Blood Cell Count Decreased
|
7.7%
4/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Insomnia
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
4/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
5.8%
3/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.7%
4/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
61.5%
32/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
26/52 • On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 4276 days for Lapatinib, including the 30 days safety follow- up (treatment duration ranged from 13 to 4246 days) and 3384 days for Capecitabine, including the 30 days safety follow up (treatment duration ranged from 8 to 3354 days).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER