Trial Outcomes & Findings for Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer (NCT NCT00482391)
NCT ID: NCT00482391
Last Updated: 2017-05-12
Results Overview
The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
2 years
Results posted on
2017-05-12
Participant Flow
Participant milestones
| Measure |
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
|
|---|---|
|
Overall Study
STARTED
|
95
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
Baseline characteristics by cohort
| Measure |
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
n=95 Participants
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.
Outcome measures
| Measure |
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
n=92 Participants
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
|
|---|---|
|
Number of Patients Who Completed All Planned Therapy
|
45 participants
|
SECONDARY outcome
Timeframe: 2 yearsPlease see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.
Outcome measures
| Measure |
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
n=95 Participants
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
|
|---|---|
|
Number of Patients Who Were Evaluated for Toxicity
|
95 Participants
|
Adverse Events
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
Serious events: 23 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
n=95 participants at risk
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
|
|---|---|
|
Metabolism and nutrition disorders
Cholesterol,high(hypercholestremia)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
3/95 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.3%
6/95 • Number of events 6
|
|
Blood and lymphatic system disorders
Edema: limb
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Fever
|
4.2%
4/95 • Number of events 4
|
|
General disorders
Flu-like syndrome
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
1.1%
1/95 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematoma
|
1.1%
1/95 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.1%
2/95 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
2.1%
2/95 • Number of events 2
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
|
2.1%
2/95 • Number of events 2
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Gingivitis(oral-gums)
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Inf unknown ANC-Cellulitis(skin)
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Inf unknown ANC-Pneumonia(lung)
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Catheter-related
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Skin (cellulites)
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Infection, other
|
2.1%
2/95 • Number of events 2
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
1.1%
1/95 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
1.1%
1/95 • Number of events 1
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Neutrophils/granulocytes (ANC/AGC)
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Other (specify)
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Pain - Head/headache
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Pain - Muscle
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Pain - Other (specify)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malig)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulm infiltrates
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Prolonged QTc interval
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Rigors/chills
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
1.1%
1/95 • Number of events 1
|
Other adverse events
| Measure |
AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
n=95 participants at risk
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT
|
23.2%
22/95
|
|
Metabolism and nutrition disorders
AST, SGOT
|
10.5%
10/95
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
6.3%
6/95
|
|
Gastrointestinal disorders
Constipation
|
8.4%
8/95
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
5/95
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
8.4%
8/95
|
|
Gastrointestinal disorders
Diarrhea
|
52.6%
50/95
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.3%
6/95
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
51.6%
49/95
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
30.5%
29/95
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
25.3%
24/95
|
|
Blood and lymphatic system disorders
Hemoglobin
|
52.6%
50/95
|
|
Endocrine disorders
Hot flashes/flushes
|
7.4%
7/95
|
|
Infections and infestations
Infection
|
16.8%
16/95
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
9.5%
9/95
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
38.9%
37/95
|
|
Blood and lymphatic system disorders
Lymphopenia
|
40.0%
38/95
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
12.6%
12/95
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
7.4%
7/95
|
|
Gastrointestinal disorders
Nausea
|
18.9%
18/95
|
|
Nervous system disorders
Neuropathy: sensory
|
16.8%
16/95
|
|
Infections and infestations
Neutrophils/granulocytes (ANC/AGC)
|
27.4%
26/95
|
|
General disorders
Pain - Head/headache
|
7.4%
7/95
|
|
General disorders
Pain - Other (specify)
|
7.4%
7/95
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.4%
8/95
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
7/95
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place