Trial Outcomes & Findings for Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer (NCT NCT00193037)
NCT ID: NCT00193037
Last Updated: 2013-07-31
Results Overview
ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
18 Months
Results posted on
2013-07-31
Participant Flow
Participant milestones
| Measure |
Arm A -Liposomal Doxorubicin Then Docetaxel
Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria.
|
Arm B - Docetaxel Then Liposomal Doxorubicin
Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
|
|---|---|---|
|
Randomized Treatment
STARTED
|
50
|
52
|
|
Randomized Treatment
COMPLETED
|
32
|
24
|
|
Randomized Treatment
NOT COMPLETED
|
18
|
28
|
|
Crossover Treatment
STARTED
|
32
|
24
|
|
Crossover Treatment
COMPLETED
|
32
|
24
|
|
Crossover Treatment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A -Liposomal Doxorubicin Then Docetaxel
n=50 Participants
Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.
|
Arm B - Docetaxel Then Liposomal Doxorubicin
n=52 Participants
Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
52 participants
n=7 Participants
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsPopulation: Patients who were removed from treatment before evaluation were not included in analysis
ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.
Outcome measures
| Measure |
Arm A -Liposomal Doxorubicin Then Docetaxel
n=42 Participants
Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.
|
Arm B - Docetaxel Then Liposomal Doxorubicin
n=44 Participants
Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.
|
|---|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
28 percentage of patients
Interval 16.0 to 42.0
|
31 percentage of patients
Interval 18.0 to 45.0
|
SECONDARY outcome
Timeframe: 18 MonthsPFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.
Outcome measures
| Measure |
Arm A -Liposomal Doxorubicin Then Docetaxel
n=48 Participants
Liposomal doxorubicin (Arm A)
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.
Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.
|
Arm B - Docetaxel Then Liposomal Doxorubicin
n=44 Participants
Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.
Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.
|
|---|---|---|
|
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
|
6.5 months
Interval 3.6 to 9.5
|
5.5 months
Interval 4.9 to 9.6
|
Adverse Events
Arm A - Liposomal Doxorubicin Then Docetaxel
Serious events: 18 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm B - Docetaxel Then Liposomal Doxorubicin
Serious events: 22 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Liposomal Doxorubicin Then Docetaxel
n=50 participants at risk
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria.
|
Arm B - Docetaxel Then Liposomal Doxorubicin
n=52 participants at risk
Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
General disorders
Failure to Thrive
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
2/50 • Number of events 2
|
0.00%
0/52
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Hepatobiliary disorders
Liver Dysfunction
|
2.0%
1/50 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Gastrointestinal disorders
Pain - Abdominal
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Gastrointestinal disorders
Hemorrhage - GI
|
2.0%
1/50 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50
|
3.8%
2/52 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Vascular disorders
Superior Vena Cava Syndome
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Musculoskeletal
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/50
|
1.9%
1/52 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
8.0%
4/50 • Number of events 4
|
9.6%
5/52 • Number of events 5
|
|
Cardiac disorders
Cardiac Arrest
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Gastrointestinal disorders
Diverticular Abscess
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
|
Nervous system disorders
CNS Ischemia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/52
|
Other adverse events
| Measure |
Arm A - Liposomal Doxorubicin Then Docetaxel
n=50 participants at risk
Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria.
|
Arm B - Docetaxel Then Liposomal Doxorubicin
n=52 participants at risk
Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
10.0%
5/50 • Number of events 5
|
1.9%
1/52 • Number of events 1
|
|
General disorders
Fatigue
|
6.0%
3/50 • Number of events 3
|
25.0%
13/52 • Number of events 13
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
8.0%
4/50 • Number of events 4
|
5.8%
3/52 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
10.0%
5/50 • Number of events 5
|
0.00%
0/52
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
4.0%
2/50 • Number of events 2
|
11.5%
6/52 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia/Myalgia
|
4.0%
2/50 • Number of events 2
|
9.6%
5/52 • Number of events 5
|
|
Blood and lymphatic system disorders
Edema
|
0.00%
0/50
|
7.7%
4/52 • Number of events 4
|
|
Cardiac disorders
Hypotension
|
0.00%
0/50
|
5.8%
3/52 • 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