Trial Outcomes & Findings for Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen (NCT NCT00118157)

NCT ID: NCT00118157

Last Updated: 2017-12-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2017-12-04

Participant Flow

Participant milestones

Measure	Arm 1 Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. lapatinib ditosylate: Given orally tamoxifen citrate: Given orally
Overall Study STARTED	19
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Arm 1 Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. lapatinib ditosylate: Given orally tamoxifen citrate: Given orally
Overall Study Adverse Event	2
Overall Study Death	8
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen

Baseline characteristics by cohort

Measure	Arm 1 n=19 Participants Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. lapatinib ditosylate: Given orally tamoxifen citrate: Given orally
Age, Continuous	57 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Arm 1 n=17 Participants Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. lapatinib ditosylate: Given orally tamoxifen citrate: Given orally
Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)	1 participants Interval 1.0 to 27.0

SECONDARY outcome

Timeframe: Baseline and at 21 days

Population: Data were not collected due to feasibility.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 19 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=19 participants at risk Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. lapatinib ditosylate: Given orally tamoxifen citrate: Given orally
Blood and lymphatic system disorders Hemolysis	15.8% 3/19 • Number of events 3
Cardiac disorders Pericardial effusion	5.3% 1/19 • Number of events 1
Cardiac disorders Supraventricular tachycardia	5.3% 1/19 • Number of events 1
Gastrointestinal disorders Diarrhea	100.0% 19/19 • Number of events 19
General disorders Death NOS	52.6% 10/19 • Number of events 10
General disorders Fatigue	68.4% 13/19 • Number of events 13
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	26.3% 5/19 • Number of events 5
Skin and subcutaneous tissue disorders Rash maculo-papular	15.8% 3/19 • Number of events 3
Vascular disorders Thromboembolic event	5.3% 1/19 • Number of events 1
Cardiac disorders Cardiac disorders - Other, specify	21.1% 4/19 • Number of events 4
Cardiac disorders Chest pain - cardiac	5.3% 1/19 • Number of events 1
Investigations White blood cell decreased	15.8% 3/19 • Number of events 3
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • Number of events 1
Metabolism and nutrition disorders Hypocalcemia	10.5% 2/19 • Number of events 2

Other adverse events

Measure	Arm 1 n=19 participants at risk Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28. lapatinib ditosylate: Given orally tamoxifen citrate: Given orally
Blood and lymphatic system disorders Anemia	36.8% 7/19 • Number of events 7
Gastrointestinal disorders Nausea	36.8% 7/19 • Number of events 7
Gastrointestinal disorders Vomiting	21.1% 4/19 • Number of events 4
Infections and infestations Infections and infestations - Other, specify	10.5% 2/19 • Number of events 2
Investigations Weight loss	21.1% 4/19 • Number of events 4
Metabolism and nutrition disorders Anorexia	31.6% 6/19 • Number of events 6
Metabolism and nutrition disorders Hyperglycemia	15.8% 3/19 • Number of events 3
Metabolism and nutrition disorders Hypoalbuminemia	15.8% 3/19 • Number of events 3
Metabolism and nutrition disorders Hypophosphatemia	10.5% 2/19 • Number of events 2
Musculoskeletal and connective tissue disorders Back pain	10.5% 2/19 • Number of events 2
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.3% 1/19 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in extremity	21.1% 4/19 • Number of events 4
Skin and subcutaneous tissue disorders Hirsutism	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders Rash acneiform	10.5% 2/19 • Number of events 2
Eye disorders Conjunctivitis	5.3% 1/19 • Number of events 1
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • Number of events 1
Gastrointestinal disorders Dry mouth	10.5% 2/19 • Number of events 2
Gastrointestinal disorders Dyspepsia	10.5% 2/19 • Number of events 2
General disorders Gait disturbance	5.3% 1/19 • Number of events 1
General disorders Non-cardiac chest pain	5.3% 1/19 • Number of events 1
General disorders Pain	15.8% 3/19 • Number of events 3
Investigations Alanine aminotransferase increased	5.3% 1/19 • Number of events 1
Investigations Alkaline phosphatase increased	5.3% 1/19 • Number of events 1
Investigations Aspartate aminotransferase increased	5.3% 1/19 • Number of events 1
Investigations Creatinine increased	15.8% 3/19 • Number of events 3
Investigations Neutrophil count decreased	5.3% 1/19 • Number of events 1
Investigations Platelet count decreased	10.5% 2/19 • Number of events 2
Metabolism and nutrition disorders Hypoglycemia	10.5% 2/19 • Number of events 2
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 • Number of events 1
Musculoskeletal and connective tissue disorders Bone pain	5.3% 1/19 • Number of events 1
Nervous system disorders Dizziness	26.3% 5/19 • Number of events 5
Nervous system disorders Headache	5.3% 1/19 • Number of events 1
Nervous system disorders Peripheral motor neuropathy	5.3% 1/19 • Number of events 1
Nervous system disorders Peripheral sensory neuropathy	5.3% 1/19 • Number of events 1
Psychiatric disorders Anxiety	5.3% 1/19 • Number of events 1
Psychiatric disorders Depression	10.5% 2/19 • Number of events 2
Psychiatric disorders Insomnia	5.3% 1/19 • Number of events 1
Reproductive system and breast disorders Vaginal discharge	5.3% 1/19 • Number of events 1
Reproductive system and breast disorders Vaginal dryness	5.3% 1/19 • Number of events 1
Reproductive system and breast disorders Vaginal hemorrhage	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	26.3% 5/19 • Number of events 5
Respiratory, thoracic and mediastinal disorders Sinus disorder	10.5% 2/19 • Number of events 2
Skin and subcutaneous tissue disorders Dry skin	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders Hyperhidrosis	10.5% 2/19 • Number of events 2
Skin and subcutaneous tissue disorders Pruritus	5.3% 1/19 • Number of events 1
Vascular disorders Hot flashes	5.3% 1/19 • Number of events 1
Vascular disorders Hypertension	5.3% 1/19 • Number of events 1
Vascular disorders Vascular disorders - Other, specify	5.3% 1/19 • Number of events 1

Additional Information

Sayeh Lavasani, M.D.

Barbara Ann Karmanos Cancer Institute

Phone: (313) 576-8751

Email: lavasans@karmanos.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60