BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00528567
First received: September 11, 2007
Last updated: August 5, 2015
Last verified: August 2015

September 11, 2007
August 5, 2015
December 2007
February 2012   (final data collection date for primary outcome measure)
  • Time to Invasive Disease-free Survival (IDFS) Event [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.
  • Percentage of Participants With Invasive Disease-free Survival (IDFS) Events [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ] [ Designated as safety issue: No ]
    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.
  • Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.
  • Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.
Invasive disease-free survival.
Complete list of historical versions of study NCT00528567 on ClinicalTrials.gov Archive Site
  • Time to Overall Survival (OS) Event [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
  • Time to Overall Survival (OS) Event [ Time Frame: Event driven (until data cutoff: 30 June 2014: up to 77 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
  • Percentage of Participants With Overall Survival (OS) Event [ Time Frame: Event driven (until data cut off: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
  • Percentage of Participants With Overall Survival (OS) Event [ Time Frame: Event driven (until data cut off: 30 June 2014: up to 77 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
  • Time to Breast Cancer-Free Interval (BCFI) Event [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.
  • Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.
  • Time to Disease-Free Survival (DFS) Event [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).
  • Percentage of Participants With Disease-Free Survival (DFS) Events [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.
  • Time to Distant Disease-Free Survival (DDFS) Event [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).
  • Percentage of Participants With Distant Disease-Free Survival (DDFS) Events [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ] [ Designated as safety issue: No ]
    DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.
  • Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths [ Time Frame: Through end of study: 30 June 2014: up to 77 months ] [ Designated as safety issue: No ]

    An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

    A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Overall survival, breast cancer-free interval, disease-free survival, distant disease-free survival. Safety and tolerability
Not Provided
Not Provided
 
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.

The secondary objectives of this trial are to:

  • compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
  • evaluate the safety and tolerability of bevacizumab

An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Bevacizumab
    Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
    Other Name: Avastin
  • Drug: Standard adjuvant chemotherapy
    All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
  • Experimental: Bevacizumab and Chemotherapy
    Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
    Interventions:
    • Drug: Bevacizumab
    • Drug: Standard adjuvant chemotherapy
  • Active Comparator: Chemotherapy
    Participants randomized to receive standard adjuvant chemotherapy as prescribed.
    Intervention: Drug: Standard adjuvant chemotherapy
Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. doi: 10.1016/S1470-2045(13)70335-8. Epub 2013 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2591
June 2014
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • operable primary invasive breast cancer;
  • completed definitive loco-regional surgery;
  • primary tumor centrally confirmed as triple negative.

Exclusion Criteria:

  • locally advanced breast cancers;
  • previous breast cancer history;
  • clinically significant cardiovascular disease.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Canada,   China,   Costa Rica,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Kingdom
Former Serbia and Montenegro
 
NCT00528567
BO20289, 2007-001128-11
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP