Clinical trial NCT01461044: An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-27
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* 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

Exclusion Criteria:

* Patients not willing to give informed consent

Primary outcomes:
measure: Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis
timeFrame: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis
timeFrame: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Disease-Free Interval
timeFrame: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Mean Age at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Mean Body Weight at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Mean Height at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With HR Status at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
measure: Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression
timeFrame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Secondary outcomes:
measure: Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
timeFrame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
measure: Percentage of Participants With Disease Progression or Death
timeFrame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
measure: Progression-Free Survival
timeFrame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
measure: Time to Progression
timeFrame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
measure: Percentage of Participants With Death
timeFrame: From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Overall Survival (OS)
timeFrame: From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Duration of Bevacizumab as First Line Treatment
timeFrame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Percentage of Participants With Temporary Discontinuation
timeFrame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Percentage of Participants With Reasons for Temporary Discontinuation
timeFrame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Percentage of Participants With Definitive Discontinuation
timeFrame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Percentage of Participants With Reasons for Definitive Discontinuation
timeFrame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease
timeFrame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
measure: Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab
timeFrame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Other outcomes:
Locations:
city: Aix En Provence
country: France
city: Aix En Provence
country: France
city: Ajaccio
country: France
city: Amiens
country: France
city: Antony
country: France
city: Arras
country: France
city: Bastia
country: France
city: Bayonne
country: France
city: Beauvais
country: France
city: Besancon
country: France
city: Beziers
country: France
city: Bobigny
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne-billancourt
country: France
city: Bourg En Bresse
country: France
city: Brest
country: France
city: Caen
country: France
city: Chambery
country: France
city: Chateauroux
country: France
city: Cherbourg Octeville
country: France
city: Clermont Ferrand
country: France
city: Clermont Ferrand
country: France
city: Creteil
country: France
city: DAX
country: France
city: Dijon
country: France
city: Eaubonne
country: France
city: Evreux
country: France
city: Grenoble
country: France
city: La Chaussee St Victor
country: France
city: La Roche Sur Yon
country: France
city: La Tronche
country: France
city: Le Coudray
country: France
city: Lille
country: France
city: Lille
country: France
city: Limoges
country: France
city: Longjumeau
country: France
city: Lorient
country: France
city: Lormont
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Metz
country: France
city: Montivilliers
country: France
city: Mougins
country: France
city: Nancy
country: France
city: Narbonne
country: France
city: Nice
country: France
city: Osny
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perigueux
country: France
city: Reims
country: France
city: Romans Sur Isere
country: France
city: Rouen
country: France
city: Rouen
country: France
city: Saint Brieuc
country: France
city: Saint Gregoire
country: France
city: Saint Jean
country: France
city: Senlis
country: France
city: Soyaux
country: France
city: St Cloud
country: France
city: St Germain En Laye
country: France
city: St Michel
country: France
city: St Priest En Jarez
country: France
city: Strasbourg
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Troyes
country: France
city: Valence
country: France
city: Vannes
country: France
city: Verdun
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: