An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer

NCT01461044 | Completed Results

• 1 other identifier: ML27760
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 82

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (22)

• 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients not willing to give informed consent

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (82)

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Aix-en-Provence, 13616, France

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Aix-en-Provence, 13617, France

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Ajaccio, 20176, France

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Amiens, 80090, France

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Antony, 92166, France

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Arras, 62012, France

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Bastia, 20200, France

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Bayonne, 64100, France

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Beauvais, 60021, France

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Besançon, 25030, France

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Béziers, 34535, France

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Bobigny, 93009, France

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Bordeaux, 33030, France

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Bordeaux, 33077, France

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Boulogne-Billancourt, 92100, France

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Bourg-en-Bresse, 01012, France

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Brest, 29609, France

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Caen, 14076, France

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Chambéry, 73011, France

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Châteauroux, 36019, France

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Cherbourg Octeville, 50102, France

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Clermont-Ferrand, 63011, France

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Clermont-Ferrand, 63050, France

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Créteil, 94010, France

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Dax, 40107, France

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Dijon, 21079, France

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Eaubonne, 95602, France

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Évreux, 27025, France

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Grenoble, 38000, France

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La Chaussée-Saint-Victor, 41260, France

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La Roche-sur-Yon, 85925, France

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La Tronche, 38700, France

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Le Coudray, 28630, France

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Lille, 59003, France

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Lille, 59020, France

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Limoges, 87042, France

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Longjumeau, 91161, France

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Lorient, 56322, France

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Lormont, 33310, France

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Lyon, 69337, France

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Lyon, 69373, France

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Marseille, 13004, France

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Marseille, 13273, France

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Marseille, 13285, France

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Metz, 57045, France

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Montivilliers, 76290, France

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Mougins, 06250, France

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Nancy, 54100, France

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Narbonne, 11108, France

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Nice, 06189, France

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Osny, 95520, France

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Paris, 75181, France

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Paris, 75230, France

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Paris, 75231, France

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Paris, 75475, France

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Paris, 75571, France

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Paris, 75651, France

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Paris, 75674, France

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Paris, 75970, France

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Périgueux, 24000, France

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Reims, 51057, France

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Romans-sur-Isère, 26102, France

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Rouen, 76000, France

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Rouen, 76044, France

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Saint-Brieuc, 22015, France

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Saint-Cloud, 92210, France

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Saint-Germain-en-Laye, 78105, France

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Saint-Grégoire, 35768, France

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Saint-Jean, 31240, France

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Saint-Michel-sur-Orge, 16470, France

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Saint-Priest-en-Jarez, 42271, France

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Senlis, 60309, France

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Soyaux, 16800, France

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Strasbourg, 67010, France

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Toulon, 83056, France

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Toulouse, 31076, France

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Toulouse, France

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Troyes, 10003, France

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Valence, 26953, France

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Vannes, 56001, France

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Verdun, 55107, France

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Villejuif, 94805, France

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 27, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 26, 2016
• Results First Posted: January 26, 2016

Record last verified: 2015-12

Locations

FR (82)