Trial Outcomes & Findings for Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer (NCT NCT00503906)
NCT ID: NCT00503906
Last Updated: 2017-05-12
Results Overview
Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2017-05-12
Participant Flow
Participant milestones
| Measure |
Abraxane, Avastin and Gemcitabine
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Abraxane, Avastin and Gemcitabine
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Abraxane, Avastin and Gemcitabine
n=30 Participants
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
53.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsProgression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.
Outcome measures
| Measure |
Abraxane, Avastin and Gemcitabine
n=29 Participants
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Median Progression-Free Survival
|
10.4 months
Interval 5.6 to 15.2
|
SECONDARY outcome
Timeframe: After two cycles, about 60 daysPopulation: Evaluable patients are study-eligible patients who receive an initial infusion of combination chemotherapy consisting of Gemcitabine, NAB paclitaxel and Bevacizumab and have had at least one CT scan for evaluation of disease status.
Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.
Outcome measures
| Measure |
Abraxane, Avastin and Gemcitabine
n=29 Participants
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants
Overall Response Rate (ORR)
|
75.6 percentage of participants
|
|
Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants
Complete Response (CR)
|
27.6 percentage of participants
|
|
Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants
Partial Response (PR)
|
48.3 percentage of participants
|
SECONDARY outcome
Timeframe: Over the course of study treatment.Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.
Outcome measures
| Measure |
Abraxane, Avastin and Gemcitabine
n=29 Participants
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Rate of Toxicity in Study Participants
Alopecia, Grade 1/2
|
65.5 percentage of participants
|
|
Rate of Toxicity in Study Participants
Fatigue, Grade 1/2
|
37.9 percentage of participants
|
|
Rate of Toxicity in Study Participants
Bone Pain, Grade 1/2
|
31 percentage of participants
|
|
Rate of Toxicity in Study Participants
Nausea, Grade 1/2
|
31 percentage of participants
|
|
Rate of Toxicity in Study Participants
Skin rash/lesions, Grade 1/2
|
27.6 percentage of participants
|
|
Rate of Toxicity in Study Participants
Neutropenia, Grade 1/2
|
10.3 percentage of participants
|
|
Rate of Toxicity in Study Participants
Grade 3/4 Toxicities
|
27.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, over the course of Treatment, about 1 yearPopulation: Data were not collected for this outcome measure.
Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, over the course of treatment, about 1 yearPopulation: Data were not collected for this outcome measure.
Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 18 monthsRate of overall survival in study participants. Overall survival will be measured from the date of enrollment to the date of death from any cause, or the date of last contact (censored observations.)
Outcome measures
| Measure |
Abraxane, Avastin and Gemcitabine
n=29 Participants
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Rate of Overall Survival in Study Participants
|
77.2 percentage of participants
Interval 51.1 to 90.5
|
Adverse Events
Abraxane, Avastin and Gemcitabine
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abraxane, Avastin and Gemcitabine
n=29 participants at risk
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29
|
|
Nervous system disorders
Peripheral Neuropathy
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
PortAcath infection
|
6.9%
2/29
|
|
Infections and infestations
Abscess
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.4%
1/29
|
|
Infections and infestations
Breast Abscess
|
3.4%
1/29
|
|
Infections and infestations
Fever/Sepsis
|
3.4%
1/29
|
|
Renal and urinary disorders
Hematuria
|
3.4%
1/29
|
|
Infections and infestations
Neutropenic Fever
|
3.4%
1/29
|
|
Nervous system disorders
Seizure/Syncope
|
3.4%
1/29
|
|
Surgical and medical procedures
Tamponade
|
3.4%
1/29
|
|
Renal and urinary disorders
UTI
|
3.4%
1/29
|
Other adverse events
| Measure |
Abraxane, Avastin and Gemcitabine
n=29 participants at risk
Each treatment cycle is 28 days. Participants will be treated until disease progression:
* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
10.3%
3/29
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
65.5%
19/29
|
|
General disorders
Fatigue
|
37.9%
11/29
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
31.0%
9/29
|
|
Gastrointestinal disorders
Nausea
|
27.6%
8/29
|
|
Skin and subcutaneous tissue disorders
Skin rash/lesion
|
27.6%
8/29
|
|
Musculoskeletal and connective tissue disorders
Hand/Foot syndrome
|
24.1%
7/29
|
|
General disorders
Headache
|
24.1%
7/29
|
|
Vascular disorders
Epistaxis
|
20.7%
6/29
|
|
Nervous system disorders
Peripheral Neuropathy
|
17.2%
5/29
|
|
Gastrointestinal disorders
Diarrhea
|
13.8%
4/29
|
|
General disorders
Insomnia
|
13.8%
4/29
|
|
Psychiatric disorders
Anxiety
|
10.3%
3/29
|
|
Vascular disorders
Hypertension
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
PortAcath Disorder
|
3.4%
1/29
|
|
Infections and infestations
Abscess
|
3.4%
1/29
|
|
Reproductive system and breast disorders
Amenorrhea
|
6.9%
2/29
|
|
Eye disorders
Blurred Vision
|
6.9%
2/29
|
|
General disorders
Cough
|
6.9%
2/29
|
|
Psychiatric disorders
Depression
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Dysgeusia
|
6.9%
2/29
|
|
Infections and infestations
Flu-like symptoms
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Loss of appetite
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Lymphedema
|
6.9%
2/29
|
|
Infections and infestations
Oral infection
|
6.9%
2/29
|
|
Infections and infestations
Rhinorrhea
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
6.9%
2/29
|
|
General disorders
Weight Loss
|
6.9%
2/29
|
|
Renal and urinary disorders
Acute renal insufficiency
|
3.4%
1/29
|
|
Cardiac disorders
Chest Pain
|
3.4%
1/29
|
|
Eye disorders
Conjunctivitis
|
3.4%
1/29
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29
|
|
Gastrointestinal disorders
Heartburn
|
3.4%
1/29
|
|
Endocrine disorders
Heat intolerance
|
3.4%
1/29
|
|
Endocrine disorders
Hot flashes
|
3.4%
1/29
|
|
Hepatobiliary disorders
Jaundice
|
3.4%
1/29
|
|
Infections and infestations
Mucositis
|
3.4%
1/29
|
|
Infections and infestations
Painful edema
|
3.4%
1/29
|
|
Infections and infestations
Pedal edema
|
3.4%
1/29
|
|
General disorders
Pelvic pain
|
3.4%
1/29
|
|
Cardiac disorders
Pericardial effusion
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
3.4%
1/29
|
|
Gastrointestinal disorders
Reflux
|
3.4%
1/29
|
|
Gastrointestinal disorders
Regurgitation (valve)
|
3.4%
1/29
|
|
Eye disorders
Scotoma
|
3.4%
1/29
|
|
Cardiac disorders
Tachycardia
|
3.4%
1/29
|
|
Vascular disorders
Thrombus
|
3.4%
1/29
|
|
Cardiac disorders
Tricuspid Regurg
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.4%
1/29
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29
|
Additional Information
Stefan Gluck MD
UM/Sylvester Comprehensive Cancer CEnter
Phone: 305-243-4909
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place