Trial Outcomes & Findings for Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer (NCT NCT00193063)
NCT ID: NCT00193063
Last Updated: 2014-03-12
Results Overview
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
18 Months
Results posted on
2014-03-12
Participant Flow
Participant milestones
| Measure |
Gemcitabine/Trastuzumab
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Gemcitabine/Trastuzumab
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Adverse Event
|
1
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Baseline Characteristics
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine/Trastuzumab
n=41 Participants
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Age, Continuous
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57 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
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Region of Enrollment
United States
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41 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsThe Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Gemcitabine/Trastuzumab
n=37 Participants
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Overall Response Rate (ORR)
|
30 percentage of participants
Interval 17.0 to 46.0
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SECONDARY outcome
Timeframe: 21 MonthsThe Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Gemcitabine/Trastuzumab
n=41 Participants
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Progression Free Survival (PFS)
|
4 months
Interval 1.9 to 5.3
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SECONDARY outcome
Timeframe: 24 monthsThe Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Outcome measures
| Measure |
Gemcitabine/Trastuzumab
n=41 Participants
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Overall Survival (OS)
|
21 months
Interval 11.5 to 30.5
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Adverse Events
Intervention
Serious events: 14 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=41 participants at risk
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Psychiatric disorders
Confusion
|
2.4%
1/41 • Number of events 1
|
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Skin and subcutaneous tissue disorders
Cellulitis
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4.9%
2/41 • Number of events 2
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Infections and infestations
Infection - pneumonia
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4.9%
2/41 • Number of events 3
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41 • Number of events 1
|
|
Hepatobiliary disorders
Liver failure
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2.4%
1/41 • Number of events 1
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|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
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2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
4.9%
2/41 • Number of events 2
|
|
Infections and infestations
Infection - port site
|
4.9%
2/41 • Number of events 3
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Gastrointestinal disorders
Duodenal ulcer
|
2.4%
1/41 • Number of events 1
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
7.3%
3/41 • Number of events 3
|
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General disorders
Fever
|
4.9%
2/41 • Number of events 2
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Gastrointestinal disorders
Vomiting
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4.9%
2/41 • Number of events 2
|
|
Infections and infestations
Infection - urinary tract
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Death NOS
|
2.4%
1/41 • Number of events 1
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Other adverse events
| Measure |
Intervention
n=41 participants at risk
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
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|---|---|
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Blood and lymphatic system disorders
Hemoglobin
|
80.5%
33/41 • Number of events 104
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Skin and subcutaneous tissue disorders
Alopecia
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26.8%
11/41 • Number of events 37
|
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Musculoskeletal and connective tissue disorders
Arthralgia
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19.5%
8/41 • Number of events 14
|
|
Gastrointestinal disorders
Constipation
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24.4%
10/41 • Number of events 17
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Gastrointestinal disorders
Diarrhea
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22.0%
9/41 • Number of events 23
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General disorders
Fatigue
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85.4%
35/41 • Number of events 125
|
|
Cardiac disorders
Hypertension
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17.1%
7/41 • Number of events 14
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Cardiac disorders
Hypotension
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14.6%
6/41 • Number of events 6
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Musculoskeletal and connective tissue disorders
Myalgia
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22.0%
9/41 • Number of events 14
|
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Gastrointestinal disorders
Nausea
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68.3%
28/41 • Number of events 56
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
5/41 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
39.0%
16/41 • Number of events 22
|
|
Gastrointestinal disorders
Anorexia
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26.8%
11/41 • Number of events 24
|
|
General disorders
Rigors/chills
|
9.8%
4/41 • Number of events 4
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|
General disorders
Fever
|
31.7%
13/41 • Number of events 16
|
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Blood and lymphatic system disorders
Leukocytes
|
63.4%
26/41 • Number of events 74
|
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Gastrointestinal disorders
Mucositis
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9.8%
4/41 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutrophils
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68.3%
28/41 • Number of events 67
|
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Blood and lymphatic system disorders
Platelets
|
61.0%
25/41 • Number of events 69
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General disorders
Weight loss
|
7.3%
3/41 • Number of events 4
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER