An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer
An Ambispective, Non Interventional Study of 2 Cohorts (Triple Negative or HR+) of Patients With HER2- Metastatic or Locally Advanced Breast Cancer Treated With Avastin® (Bevacizumab) 1st Line for at Least 12 Months and Without Progression for at Least 12 Months.
This date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)
Study Completion
November 2013
Actual (reported)
Brief Summary
This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. Data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
228 participants
Study completion date
November 2013
Actual (reported)
Listed locations
1 countries · 82 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
September 2011
Date type not reported
This date has not been verified as actual or estimated.
Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.
From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.
From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Disease-Free Interval
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).
From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Age at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression
Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression
ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50 percentage \[%\] of waking hours \[h\]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Body Weight at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Height at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression
BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression
Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression
Percentage of participants that reported metastatic disease in less than or equal to (\<=) 3 sites or greater than (\>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With HR Status at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression
MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression
The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with \< or \>=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Secondary Outcomes (13)
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Percentage of Participants With Disease Progression or Death
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Progression-Free Survival
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Time to Progression
From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Percentage of Participants With Death
From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Study Arms (1)
Cohort
Eligibility Criteria
Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population
Patients (triple negative or HR+) with HER2- metastatic or locally advanced breast cancer, treated with Avastin 1st line for at least 12 months and without progression for at least 12 months.
HER2-metastatic breast cancer or locally advanced breast cancer
Patients with Avastin as first line therapy administered for at least 12 months
Patients without disease progression after the beginning of Avastin treatment for at least 12 months
You may not qualify if:
Patients not willing to give informed consent
Contact the study team to confirm eligibility.
Beauvais, 60021, France
Besançon, 25030, France
Béziers, 34535, France
Bobigny, 93009, France
Bordeaux, 33030, France
Bordeaux, 33077, France
Boulogne-Billancourt, 92100, France
Bourg-en-Bresse, 01012, France
Brest, 29609, France
Caen, 14076, France
Chambéry, 73011, France
Châteauroux, 36019, France
Cherbourg Octeville, 50102, France
Clermont-Ferrand, 63011, France
Clermont-Ferrand, 63050, France
Créteil, 94010, France
Dax, 40107, France
Dijon, 21079, France
Eaubonne, 95602, France
Évreux, 27025, France
Grenoble, 38000, France
La Chaussée-Saint-Victor, 41260, France
La Roche-sur-Yon, 85925, France
La Tronche, 38700, France
Le Coudray, 28630, France
Lille, 59003, France
Lille, 59020, France
Limoges, 87042, France
Longjumeau, 91161, France
Lorient, 56322, France
Lormont, 33310, France
Lyon, 69337, France
Lyon, 69373, France
Marseille, 13004, France
Marseille, 13273, France
Marseille, 13285, France
Metz, 57045, France
Montivilliers, 76290, France
Mougins, 06250, France
Nancy, 54100, France
Narbonne, 11108, France
Nice, 06189, France
Osny, 95520, France
Paris, 75181, France
Paris, 75230, France
Paris, 75231, France
Paris, 75475, France
Paris, 75571, France
Paris, 75651, France
Paris, 75674, France
Paris, 75970, France
Périgueux, 24000, France
Reims, 51057, France
Romans-sur-Isère, 26102, France
Rouen, 76000, France
Rouen, 76044, France
Saint-Brieuc, 22015, France
Saint-Cloud, 92210, France
Saint-Germain-en-Laye, 78105, France
Saint-Grégoire, 35768, France
Saint-Jean, 31240, France
Saint-Michel-sur-Orge, 16470, France
Saint-Priest-en-Jarez, 42271, France
Senlis, 60309, France
Soyaux, 16800, France
Strasbourg, 67010, France
Toulon, 83056, France
Toulouse, 31076, France
Toulouse, France
Troyes, 10003, France
Valence, 26953, France
Vannes, 56001, France
Verdun, 55107, France
Villejuif, 94805, France
Primary Completion
November 2013
Actual (reported)
Study Completion
November 2013
Actual (reported)
Last Updated
January 26, 2016
Results First Posted
January 26, 2016
Record last verified: 2015-12
Source record
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Source: ClinicalTrials.gov.
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