Trial Outcomes & Findings for Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer (NCT NCT00623233)
NCT ID: NCT00623233
Last Updated: 2012-01-09
Results Overview
PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).
Results posted on
2012-01-09
Participant Flow
Participant milestones
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Physician Decision
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
n=52 Participants
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Age Continuous
|
55.2 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African descent
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
41 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
|
Estrogen Receptor (ER) Status
ER+
|
33 participants
n=5 Participants
|
|
Estrogen Receptor (ER) Status
ER-
|
19 participants
n=5 Participants
|
|
Progesterone Receptor (PR) Status
PR+
|
30 participants
n=5 Participants
|
|
Progesterone Receptor (PR) Status
PR-
|
22 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2/neu)
HER2/neu+
|
0 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2/neu)
HER2/neu-
|
52 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
28 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).Population: The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=41; censored participants=11.
PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.
Outcome measures
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
n=52 Participants
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival (PFS) Time
|
4.80 months
Interval 3.42 to 7.56
|
SECONDARY outcome
Timeframe: Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).Population: The per protocol (PP) population included all intent-to-treat (ITT) participants who met the following criteria: histological or cytological diagnosis of breast cancer; presence of measurable disease at baseline per RECIST criteria; had at least 1 dose of study drug; no current systemic anti-tumor treatment other than protocol-specified therapy.
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population).
Outcome measures
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
n=42 Participants
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Overall Tumor Response Rate (ORR)
|
0.214 proportion of responders
Interval 0.103 to 0.3681
|
SECONDARY outcome
Timeframe: Baseline, every cycle (every 14 days) up to 34 monthsPopulation: The safety population was the treated population and included all participants who received at least 1 dose of study therapy.
A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
n=52 Participants
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Adverse Events (AEs); Pharmacology Toxicities
SAEs
|
18 participants
|
|
Number of Participants With Adverse Events (AEs); Pharmacology Toxicities
Other non-serious AEs
|
51 participants
|
SECONDARY outcome
Timeframe: Baseline to death from any cause, 1 yearPopulation: The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=25; censored participants=27.
OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data.
Outcome measures
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
n=52 Participants
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
1-Year Overall Survival (OS) Rate
|
68.68 percentage of participants
Interval 54.05 to 79.5
|
Adverse Events
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
Serious events: 18 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
n=52 participants at risk
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/52 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.9%
1/52 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemolytic Uraemic Syndrome
|
1.9%
1/52 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/52 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
1/52 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/52 • Number of events 1
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.9%
1/52 • Number of events 1
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis Erosive
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/52 • Number of events 4
|
|
General disorders
Asthenia
|
1.9%
1/52 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.9%
1/52 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.9%
1/52 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/52 • Number of events 1
|
|
Infections and infestations
Sepsis
|
3.8%
2/52 • Number of events 2
|
|
Infections and infestations
Skin Infection
|
1.9%
1/52 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
1.9%
1/52 • Number of events 1
|
|
Investigations
Alanine Aminotransferase Increased
|
1.9%
1/52 • Number of events 1
|
|
Investigations
Aspartate Aminotransferase Increased
|
1.9%
1/52 • Number of events 1
|
|
Investigations
Oxygen Saturation Decreased
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid Retention
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/52 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
3.8%
2/52 • Number of events 2
|
|
Nervous system disorders
Head Discomfort
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Loss Of Consciousness
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
1.9%
1/52 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.9%
1/52 • Number of events 1
|
|
Renal and urinary disorders
Hydronephrosis
|
1.9%
1/52 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
3.8%
2/52 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.9%
1/52 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/52 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/52 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.8%
2/52 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.9%
1/52 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg
n=52 participants at risk
Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
16/52 • Number of events 18
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.2%
10/52 • Number of events 14
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.9%
14/52 • Number of events 21
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.6%
5/52 • Number of events 12
|
|
Cardiac disorders
Sinus Tachycardia
|
5.8%
3/52 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
11.5%
6/52 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.5%
6/52 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
5.8%
3/52 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
40.4%
21/52 • Number of events 22
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
12/52 • Number of events 18
|
|
Gastrointestinal disorders
Dyspepsia
|
13.5%
7/52 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
61.5%
32/52 • Number of events 51
|
|
Gastrointestinal disorders
Stomatitis
|
15.4%
8/52 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
14/52 • Number of events 17
|
|
General disorders
Asthenia
|
7.7%
4/52 • Number of events 4
|
|
General disorders
Chest Pain
|
5.8%
3/52 • Number of events 4
|
|
General disorders
Fatigue
|
61.5%
32/52 • Number of events 38
|
|
General disorders
Influenza Like Illness
|
5.8%
3/52 • Number of events 4
|
|
General disorders
Oedema
|
7.7%
4/52 • Number of events 5
|
|
General disorders
Oedema Peripheral
|
7.7%
4/52 • Number of events 4
|
|
General disorders
Pain
|
5.8%
3/52 • Number of events 4
|
|
General disorders
Pyrexia
|
13.5%
7/52 • Number of events 7
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.7%
4/52 • Number of events 4
|
|
Infections and infestations
Urinary Tract Infection
|
13.5%
7/52 • Number of events 7
|
|
Investigations
Alanine Aminotransferase Increased
|
5.8%
3/52 • Number of events 3
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.8%
3/52 • Number of events 4
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
5.8%
3/52 • Number of events 3
|
|
Investigations
Weight Decreased
|
9.6%
5/52 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
28.8%
15/52 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
7/52 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
21.2%
11/52 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.5%
6/52 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.7%
4/52 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.8%
3/52 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
3/52 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
15.4%
8/52 • Number of events 8
|
|
Nervous system disorders
Headache
|
21.2%
11/52 • Number of events 13
|
|
Nervous system disorders
Neuropathy Peripheral
|
5.8%
3/52 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
7.7%
4/52 • Number of events 4
|
|
Psychiatric disorders
Depression
|
11.5%
6/52 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
7.7%
4/52 • Number of events 5
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
13/52 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
8/52 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.8%
15/52 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.2%
10/52 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
7.7%
4/52 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
8/52 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
5/52 • Number of events 5
|
|
Vascular disorders
Hypertension
|
23.1%
12/52 • Number of events 16
|
|
Vascular disorders
Lymphoedema
|
5.8%
3/52 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60