Trial Outcomes & Findings for Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer (NCT NCT00654836)

Last Updated: 2017-09-14

Results Overview

Progression-free survival was measured from treatment initiation to 30 months. 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

30 Months

Results posted on

2017-09-14

Participant Flow

Participants with metastatic breast cancer were recruited from medical clinics between October 15, 2007 and February 15, 2012

No enrolled participant was excluded from therapy

Participant milestones

Participant milestones
Measure	Carboplatin, ABI-007 and Bevacizumab Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carboplatin, ABI-007 and Bevacizumab n=32 Participants Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
Age, Continuous	58.38 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0	22 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1	7 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 2	1 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Undetermined	2 participants n=5 Participants
Site of Metastatic Disease was Bone Yes	20 participants n=5 Participants
Site of Metastatic Disease was Bone No	12 participants n=5 Participants
Site of Metastatic Disease was Liver Yes	14 participants n=5 Participants
Site of Metastatic Disease was Liver No	18 participants n=5 Participants
Site of Metastatic Disease was Loco-regional Yes	12 participants n=5 Participants
Site of Metastatic Disease was Loco-regional No	20 participants n=5 Participants
Site of Metastatic Disease was Lung Yes	9 participants n=5 Participants
Site of Metastatic Disease was Lung No	23 participants n=5 Participants
Site of Metastatic Disease was Distant Lymph Nodes Yes	7 participants n=5 Participants
Site of Metastatic Disease was Distant Lymph Nodes No	25 participants n=5 Participants
Prior adjuvant therapy was chemotherapy Yes	17 participants n=5 Participants
Prior adjuvant therapy was chemotherapy No	15 participants n=5 Participants
Prior adjuvant therapy was endocrine therapy Yes	18 participants n=5 Participants
Prior adjuvant therapy was endocrine therapy No	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Months

Population: All enrolled participants are included in this analysis

Outcome measures

Outcome measures
Measure	Carboplatin, ABI-007 and Bevacizumab n=32 Participants Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
Progression-free Survival	16 Months Interval 9.8 to 22.2

SECONDARY outcome

Timeframe: 30 Months

Population: Of the 32 enrolled participants, two participants did not return to the clinic at 30 months for final evaluation of their response to treatment.

Response to treatment was recorded 30 months following treatment initiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 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

Outcome measures
Measure	Carboplatin, ABI-007 and Bevacizumab n=32 Participants Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
Response Rate at End of Treatment Stable Disease (SD)	3 participants
Response Rate at End of Treatment Complete Response (CR)	2 participants
Response Rate at End of Treatment Partial Response (PR)	24 participants
Response Rate at End of Treatment Progressive Disease (PD)	1 participants
Response Rate at End of Treatment Undetermined	2 participants

SECONDARY outcome

Timeframe: 80 Months

Population: All enrolled participants are included in this analysis

Overall survival was measured from treatment initiation to 80 months

Outcome measures

Outcome measures
Measure	Carboplatin, ABI-007 and Bevacizumab n=32 Participants Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
Overall Survival	21 Months Interval 13.48 to 28.52

Adverse Events

Carboplatin, ABI-007 and Bevacizumab

Serious events: 24 serious events

Other events: 31 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Carboplatin, ABI-007 and Bevacizumab n=32 participants at risk Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
General disorders Disease Progression	75.0% 24/32 • Number of events 24 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013

Other adverse events

Other adverse events
Measure	Carboplatin, ABI-007 and Bevacizumab n=32 participants at risk Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
Blood and lymphatic system disorders Abnormal hemoglobin	46.9% 15/32 • Number of events 15 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Blood and lymphatic system disorders Abnormal Leukocytes	53.1% 17/32 • Number of events 17 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Psychiatric disorders Anorexia	12.5% 4/32 • Number of events 4 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Metabolism and nutrition disorders Constipation	9.4% 3/32 • Number of events 3 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
General disorders Cough	6.2% 2/32 • Number of events 2 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
General disorders Dyspnea	12.5% 4/32 • Number of events 4 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Vascular disorders Hemorrhage of the Nose	25.0% 8/32 • Number of events 8 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Gastrointestinal disorders Nausea	15.6% 5/32 • Number of events 5 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
General disorders Chest Pain	12.5% 4/32 • Number of events 4 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
General disorders Joint Pain	6.2% 2/32 • Number of events 2 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Gastrointestinal disorders Vomiting	9.4% 3/32 • Number of events 3 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Immune system disorders Allergic reaction	6.2% 2/32 • Number of events 2 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
General disorders Proteinuria	6.2% 2/32 • Number of events 2 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
General disorders Thrombosis	6.2% 2/32 • Number of events 2 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013
Hepatobiliary disorders Abnormal Liver Test (AST)	6.2% 2/32 • Number of events 5 • Adverse event information was collected from all 32 enrolled participants between February 28, 2008 and April 26, 2013

Additional Information

Shelly S. Lo, M.D.

Loyola University

Phone: 708-327-3154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place