Trial Outcomes & Findings for Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy (NCT NCT00759642)
NCT ID: NCT00759642
Last Updated: 2019-07-01
Results Overview
Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
12 months
Results posted on
2019-07-01
Participant Flow
Participant milestones
| Measure |
Lapatinib
lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)
lapatinib: lapatinib 1500 mg PO daily
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
Baseline characteristics by cohort
| Measure |
Lapatinib
n=33 Participants
lapatinib
lapatinib: lapatinib 1500 mg PO daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsProgression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.
Outcome measures
| Measure |
Lapatinib
n=33 Participants
lapatinib + Endocrine therapy
lapatinib: lapatinib 1500 mg PO daily
|
|---|---|
|
Progression Free Survival
|
2.1 months
Interval 1.0 to 12.0
|
Adverse Events
Lapatinib
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib
n=33 participants at risk
lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)
lapatinib: lapatinib 1500 mg PO daily
|
|---|---|
|
General disorders
Neck pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Hepatobiliary disorders
Pancreatitis
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Anorexia
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Infections and infestations
Skin infection
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Eye disorders
Blurred vision
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Musculoskeletal and connective tissue disorders
Gait abnormal
|
3.0%
1/33 • 5 years (2009-2014)
|
Other adverse events
| Measure |
Lapatinib
n=33 participants at risk
lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)
lapatinib: lapatinib 1500 mg PO daily
|
|---|---|
|
General disorders
Abdominal pain
|
6.1%
2/33 • 5 years (2009-2014)
|
|
Nervous system disorders
Abducens nerve disorder
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Acne
|
27.3%
9/33 • 5 years (2009-2014)
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Psychiatric disorders
Anorexia
|
21.2%
7/33 • 5 years (2009-2014)
|
|
Nervous system disorders
Anxiety
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Ascites
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify)
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
3/33 • 5 years (2009-2014)
|
|
Eye disorders
Blurred vision
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Reproductive system and breast disorders
Breast pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Infections and infestations
Bronchitis
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Chest wall pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Psychiatric disorders
Confusion
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Constipation
|
9.1%
3/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
4/33 • 5 years (2009-2014)
|
|
Metabolism and nutrition disorders
Creatinine increased
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Dehydration
|
15.2%
5/33 • 5 years (2009-2014)
|
|
Psychiatric disorders
Depression
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Diarrhea
|
75.8%
25/33 • 5 years (2009-2014)
|
|
Eye disorders
Diplopia
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Nervous system disorders
Dizziness
|
12.1%
4/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
3/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
3/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.1%
4/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
6.1%
2/33 • 5 years (2009-2014)
|
|
General disorders
Edema limbs
|
6.1%
2/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.0%
1/33 • 5 years (2009-2014)
|
|
General disorders
Facial pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
General disorders
Fatigue
|
30.3%
10/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Fecal incontinence
|
3.0%
1/33 • 5 years (2009-2014)
|
|
General disorders
Fever
|
6.1%
2/33 • 5 years (2009-2014)
|
|
General disorders
Flu-like syndrome
|
6.1%
2/33 • 5 years (2009-2014)
|
|
Injury, poisoning and procedural complications
Fracture
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Infections and infestations
Gastric infection
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
9.1%
3/33 • 5 years (2009-2014)
|
|
General disorders
Headache
|
18.2%
6/33 • 5 years (2009-2014)
|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Heartburn
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Endocrine disorders
Hot flashes
|
9.1%
3/33 • 5 years (2009-2014)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.1%
2/33 • 5 years (2009-2014)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
3/33 • 5 years (2009-2014)
|
|
Infections and infestations
Infection, Upper airway NOS
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Psychiatric disorders
Insomnia
|
12.1%
4/33 • 5 years (2009-2014)
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Blood and lymphatic system disorders
Leukocytes
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Psychiatric disorders
Memory impairment
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Infections and infestations
Mucosal infection
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Mucositis oral
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.1%
2/33 • 5 years (2009-2014)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/paranasal reactions
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Nausea
|
39.4%
13/33 • 5 years (2009-2014)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Nervous system disorders
Neurology - Other (Specify)
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Blood and lymphatic system disorders
Neutrophils low
|
6.1%
2/33 • 5 years (2009-2014)
|
|
Eye disorders
Ocular - Other (Specify)
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Oral pain
|
6.1%
2/33 • 5 years (2009-2014)
|
|
General disorders
Pain in extremity
|
12.1%
4/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Cardiac disorders
Palpitations
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Reproductive system and breast disorders
Perineal pain
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.1%
2/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.1%
4/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.4%
12/33 • 5 years (2009-2014)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
3.0%
1/33 • 5 years (2009-2014)
|
|
General disorders
Rigors/chills
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Nervous system disorders
Tremor
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Infections and infestations
Upper respiratory infection
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Renal and urinary disorders
Urinary incontinence
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Cardiac disorders
Vasovagal episode
|
3.0%
1/33 • 5 years (2009-2014)
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
7/33 • 5 years (2009-2014)
|
|
Investigations
Weight loss
|
9.1%
3/33 • 5 years (2009-2014)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place