Trial Outcomes & Findings for Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer (NCT NCT00297596)
NCT ID: NCT00297596
Last Updated: 2021-10-28
Results Overview
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
25 participants
Primary outcome timeframe
18 months
Results posted on
2021-10-28
Participant Flow
Participant milestones
| Measure |
Oxaliplatin/Trastuzumab
Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
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|---|---|
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Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin/Trastuzumab
n=25 Participants
Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
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|---|---|
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Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPer 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 |
Oxaliplatin/Trastuzumab
n=25 Participants
Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
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|---|---|
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Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
20 percentage of participants
Interval 4.3 to 35.7
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SECONDARY outcome
Timeframe: 18 monthsTime-to-progression was defined as the interval from first study treatment until the date that breast cancer progression was documented, other treatment was given, or death occurred.
Outcome measures
| Measure |
Oxaliplatin/Trastuzumab
n=25 Participants
Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
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|---|---|
|
Time to Progression
|
1.7 months
Interval 0.5 to 12.3
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Adverse Events
Oxaliplatin/Trastuzumab
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxaliplatin/Trastuzumab
n=25 participants at risk
Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
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|---|---|
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Gastrointestinal disorders
Perforated appendix
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4.0%
1/25 • Number of events 1
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|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory failure secondary to metastatic disease
|
4.0%
1/25 • Number of events 1
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|
Respiratory, thoracic and mediastinal disorders
Right lower lobe pneumonia
|
4.0%
1/25 • Number of events 1
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|
Musculoskeletal and connective tissue disorders
Pathologic fracture of let proximal humeral diaphysis
|
4.0%
1/25 • Number of events 1
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|
Musculoskeletal and connective tissue disorders
Pathologic fracture of right proximal humeral diaphysis
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4.0%
1/25 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
4.0%
1/25 • Number of events 1
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|
Immune system disorders
Allergic reaction
|
4.0%
1/25 • Number of events 1
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|
Respiratory, thoracic and mediastinal disorders
Massive pleural effusion with total collapse of right lung
|
4.0%
1/25 • Number of events 1
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|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive disease
|
4.0%
1/25 • Number of events 1
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Other adverse events
| Measure |
Oxaliplatin/Trastuzumab
n=25 participants at risk
Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
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|---|---|
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Gastrointestinal disorders
Nausea
|
52.0%
13/25 • Number of events 29
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Musculoskeletal and connective tissue disorders
Arthralgia
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16.0%
4/25 • Number of events 6
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General disorders
Fatigue
|
80.0%
20/25 • Number of events 62
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|
Gastrointestinal disorders
Diarrhea
|
60.0%
15/25 • Number of events 38
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General disorders
Allergic Reaction
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8.0%
2/25 • Number of events 3
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|
Nervous system disorders
Neuropathy - Sensory
|
68.0%
17/25 • Number of events 52
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
5/25 • Number of events 9
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Skin and subcutaneous tissue disorders
Hair loss/alopecia
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12.0%
3/25 • Number of events 4
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|
Gastrointestinal disorders
Taste Alteration
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8.0%
2/25 • Number of events 3
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|
Gastrointestinal disorders
Anorexia
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28.0%
7/25 • Number of events 10
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|
Gastrointestinal disorders
Constipation
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24.0%
6/25 • Number of events 10
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|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
4/25 • Number of events 8
|
|
Gastrointestinal disorders
Dehydration
|
8.0%
2/25 • Number of events 2
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|
Nervous system disorders
Mood Alteration - Depression
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8.0%
2/25 • Number of events 5
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|
Gastrointestinal disorders
Heartburn/dypepsia
|
16.0%
4/25 • Number of events 4
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|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.0%
4/25 • Number of events 4
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General disorders
Fever
|
8.0%
2/25 • Number of events 2
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|
Blood and lymphatic system disorders
Hemoglobin
|
72.0%
18/25 • Number of events 48
|
|
Endocrine disorders
Hot flashes/flushes
|
8.0%
2/25 • Number of events 4
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|
General disorders
Insomnia
|
16.0%
4/25 • Number of events 8
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|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
48.0%
12/25 • Number of events 34
|
|
Nervous system disorders
Neuropathy - Motor
|
8.0%
2/25 • Number of events 3
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|
Skin and subcutaneous tissue disorders
Nail Changes
|
8.0%
2/25 • Number of events 3
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|
Blood and lymphatic system disorders
Neutrophils/ granulocytes (ANC/AGC)
|
16.0%
4/25 • Number of events 16
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|
Blood and lymphatic system disorders
Platelets
|
36.0%
9/25 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper respiratory
|
32.0%
8/25 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
32.0%
8/25 • Number of events 10
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|
Musculoskeletal and connective tissue disorders
Myalgia
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8.0%
2/25 • Number of events 3
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|
General disorders
Pain (NOS)
|
72.0%
18/25 • Number of events 42
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|
Nervous system disorders
Pain (headache)
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8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Reflux
|
8.0%
2/25 • Number of events 4
|
|
General disorders
Weakness
|
8.0%
2/25 • Number of events 3
|
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