Trial Outcomes & Findings for Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer (NCT NCT01307891)
NCT ID: NCT01307891
Last Updated: 2017-10-26
Results Overview
Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2017-10-26
Participant Flow
Participant milestones
| Measure |
Abraxane + Tigatuzumab
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
|
Abraxane Alone
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
22
|
|
Overall Study
COMPLETED
|
39
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Abraxane + Tigatuzumab
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
|
Abraxane Alone
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
1
|
Baseline Characteristics
Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Abraxane + Tigatuzumab
n=42 Participants
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
|
Abraxane Alone
n=22 Participants
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
22 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPatient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.
Outcome measures
| Measure |
Abraxane + Tigatuzumab
n=39 Participants
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
|
Abraxane Alone
n=21 Participants
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
|---|---|---|
|
Objective Response Rate
|
28 percentage of patients
Interval 14.9 to 45.0
|
38 percentage of patients
Interval 18.0 to 61.1
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPatients will be assessed throughout the study for Grade 4 or 5 toxicities utilizing the Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Abraxane + Tigatuzumab
n=39 Participants
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
|
Abraxane Alone
n=21 Participants
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through 24 monthsProgression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Abraxane + Tigatuzumab
n=39 Participants
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
|
Abraxane Alone
n=21 Participants
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
|---|---|---|
|
Progression-free Survival
|
2.8 months
Interval 1.9 to 3.6
|
3.8 months
Interval 2.8 to 19.7
|
Adverse Events
Abraxane + Tigatuzumab
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Abraxane Alone
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abraxane + Tigatuzumab
n=39 participants at risk
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks.
|
Abraxane Alone
n=21 participants at risk
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Patients will have the option to crossover to the combination arm based upon the pre-clinical data. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
|---|---|---|
|
Infections and infestations
Fever
|
2.6%
1/39 • Number of events 39 • Baseline to 24 months
|
4.8%
1/21 • Number of events 21 • Baseline to 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/39 • Number of events 1 • Baseline to 24 months
|
4.8%
1/21 • Number of events 1 • Baseline to 24 months
|
|
Infections and infestations
Empyema associated with a permanent thoracic catheter
|
2.6%
1/39 • Number of events 1 • Baseline to 24 months
|
0.00%
0/21 • Baseline to 24 months
|
|
Blood and lymphatic system disorders
Bilateral Pulmonary Thromboembolism
|
0.00%
0/39 • Baseline to 24 months
|
4.8%
1/21 • Number of events 1 • Baseline to 24 months
|
Other adverse events
| Measure |
Abraxane + Tigatuzumab
n=39 participants at risk
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks.
|
Abraxane Alone
n=21 participants at risk
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Patients will have the option to crossover to the combination arm based upon the pre-clinical data. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
|
|---|---|---|
|
General disorders
Fatigue
|
56.4%
22/39 • Number of events 22 • Baseline to 24 months
|
52.4%
11/21 • Number of events 11 • Baseline to 24 months
|
|
General disorders
Alopecia
|
48.7%
19/39 • Number of events 19 • Baseline to 24 months
|
52.4%
11/21 • Number of events 11 • Baseline to 24 months
|
|
Nervous system disorders
Pheripheral Sensory Neuropathy
|
43.6%
17/39 • Number of events 17 • Baseline to 24 months
|
47.6%
10/21 • Number of events 10 • Baseline to 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
41.0%
16/39 • Number of events 16 • Baseline to 24 months
|
42.9%
9/21 • Number of events 9 • Baseline to 24 months
|
|
Gastrointestinal disorders
Nausea
|
23.1%
9/39 • Number of events 9 • Baseline to 24 months
|
23.8%
5/21 • Number of events 5 • Baseline to 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
3/39 • Number of events 3 • Baseline to 24 months
|
14.3%
3/21 • Number of events 3 • Baseline to 24 months
|
|
Gastrointestinal disorders
Anorexia
|
5.1%
2/39 • Number of events 2 • Baseline to 24 months
|
19.0%
4/21 • Number of events 4 • Baseline to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
4/39 • Number of events 4 • Baseline to 24 months
|
9.5%
2/21 • Number of events 2 • Baseline to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
4/39 • Number of events 4 • Baseline to 24 months
|
9.5%
2/21 • Number of events 2 • Baseline to 24 months
|
Additional Information
Andres Forero, M.D.
University of Alabama at Birmingham
Phone: 205-934-7167
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place