Trial Outcomes & Findings for Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer (NCT NCT01827163)
NCT ID: NCT01827163
Last Updated: 2019-12-18
Results Overview
The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of \< 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1 year
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Paclitaxel With Trastuzumab and Lapatinib
Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase \& continued for the remaining year during the HL phase for about a year.
Paclitaxel
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Paclitaxel With Trastuzumab and Lapatinib
Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase \& continued for the remaining year during the HL phase for about a year.
Paclitaxel
|
|---|---|
|
Overall Study
Hypersensitivity reaction to Paclitaxel
|
2
|
|
Overall Study
Adverse Event
|
9
|
Baseline Characteristics
Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel With Trastuzumab and Lapatinib
n=20 Participants
Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase \& continued for the remaining year during the HL phase for about a year.
Paclitaxel
|
|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of \< 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.
Outcome measures
| Measure |
Paclitaxel With Trastuzumab and Lapatinib
n=20 Participants
Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase \& continued for the remaining year during the HL phase for about a year.
Paclitaxel
|
|---|---|
|
Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation
Did not complete treatment
|
16 Participants
|
|
Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation
Successfully completed treatment
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearAll toxicities following chemotherapy will be graded using the National Cancer Institute - Common Toxicity Criteria version 4.0.
Outcome measures
| Measure |
Paclitaxel With Trastuzumab and Lapatinib
n=20 Participants
Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase \& continued for the remaining year during the HL phase for about a year.
Paclitaxel
|
|---|---|
|
Participants Toxicity Evaluated While on Study Treatment
|
20 Participants
|
Adverse Events
Paclitaxel With Trastuzumab and Lapatinib
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel With Trastuzumab and Lapatinib
n=20 participants at risk
Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase \& continued for the remaining year during the HL phase for about a year.
Paclitaxel
|
|---|---|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • 1 year
|
|
Infections and infestations
Breast infection
|
5.0%
1/20 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • 1 year
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • 1 year
|
|
General disorders
Fatigue
|
5.0%
1/20 • 1 year
|
|
General disorders
Fever
|
5.0%
1/20 • 1 year
|
|
Hepatobiliary disorders
Hepatic failure
|
5.0%
1/20 • 1 year
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • 1 year
|
|
Nervous system disorders
Transient ischemic attacks
|
5.0%
1/20 • 1 year
|
Other adverse events
| Measure |
Paclitaxel With Trastuzumab and Lapatinib
n=20 participants at risk
Paclitaxel (T) at 175 mg/m2 q 2 weeks x 4 with filgrastim/pegfilgrastim + trastuzumab (H) + daily oral lapatinib (L), followed by trastuzumab q 3 weeks x 15 doses + daily oral lapatinib (HL). Pegfilgrastim 6mg will be given subcutaneously (SQ) on day # 2 of each paclitaxel administration. Filgrastim may be used in lieu of pegfilgrastim at physician's discretion. Trastuzumab will be administered weekly (4 mg/kg bolus followed by 2 mg/kg weekly) starting with paclitaxel treatment cycle # 1. After 4 cycles of paclitaxel, pts will receive trastuzumab on a q 3 weeks x 15 doses (to complete about one year). The q 3 week trastuzumab may be started from 1-3 weeks after the last dose of paclitaxel. A total of 15 infusions of trastuzumab will be given q 3 weeks after the completion of paclitaxel during the HL phase. Lapatinib will be given orally at 1000 mg daily, starting with paclitaxel during the THL phase \& continued for the remaining year during the HL phase for about a year.
Paclitaxel
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
16/20 • 1 year
|
|
General disorders
Fatigue
|
80.0%
16/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
80.0%
16/20 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
60.0%
12/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
55.0%
11/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
45.0%
9/20 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
8/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
40.0%
8/20 • 1 year
|
|
Vascular disorders
Hot flashes
|
40.0%
8/20 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
8/20 • 1 year
|
|
General disorders
Pain
|
40.0%
8/20 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
35.0%
7/20 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
30.0%
6/20 • 1 year
|
|
Nervous system disorders
Dizziness
|
30.0%
6/20 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
30.0%
6/20 • 1 year
|
|
General disorders
Fever
|
30.0%
6/20 • 1 year
|
|
Reproductive system and breast disorders
Irregular menstruation
|
25.0%
5/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
5/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
4/20 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
4/20 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
4/20 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
4/20 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
4/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & conn tissue disorder Other, spec
|
20.0%
4/20 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • 1 year
|
|
Investigations
Blood bilirubin increased
|
15.0%
3/20 • 1 year
|
|
General disorders
Chills
|
15.0%
3/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
3/20 • 1 year
|
|
General disorders
Edema limbs
|
15.0%
3/20 • 1 year
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.0%
3/20 • 1 year
|
|
Nervous system disorders
Memory impairment
|
15.0%
3/20 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
15.0%
3/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
15.0%
3/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
3/20 • 1 year
|
|
Investigations
Weight loss
|
15.0%
3/20 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
2/20 • 1 year
|
|
Eye disorders
Dry eye
|
10.0%
2/20 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
2/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
2/20 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.0%
2/20 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
2/20 • 1 year
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
2/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
10.0%
2/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
10.0%
2/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
10.0%
2/20 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
2/20 • 1 year
|
|
Reproductive system and breast disorders
Vaginal dryness
|
10.0%
2/20 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • 1 year
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • 1 year
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • 1 year
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.0%
1/20 • 1 year
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • 1 year
|
|
Nervous system disorders
Ataxia
|
5.0%
1/20 • 1 year
|
|
Eye disorders
Blurred vision
|
5.0%
1/20 • 1 year
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • 1 year
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • 1 year
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • 1 year
|
|
Investigations
INR increased
|
5.0%
1/20 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • 1 year
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders-Other
|
5.0%
1/20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.0%
1/20 • 1 year
|
|
Infections and infestations
Nail infection
|
5.0%
1/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
5.0%
1/20 • 1 year
|
|
Infections and infestations
Paronychia
|
5.0%
1/20 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • 1 year
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.0%
1/20 • 1 year
|
|
Infections and infestations
Rash pustular
|
5.0%
1/20 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.0%
1/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder - Other
|
5.0%
1/20 • 1 year
|
|
Infections and infestations
Rhinitis infective
|
5.0%
1/20 • 1 year
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • 1 year
|
|
Nervous system disorders
Transient ischemic attacks
|
5.0%
1/20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • 1 year
|
|
Eye disorders
Watering eyes
|
5.0%
1/20 • 1 year
|
|
Investigations
Weight gain
|
5.0%
1/20 • 1 year
|
Additional Information
Dr. Chau Dang, MD
Memorial Sloan Kettering Cancer Center
Phone: 914-367-7181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place