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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00528567
First received: September 11, 2007
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

This 2 arm open-label study is evaluating the efficacy and safety of the addition of Avastin (bevacizumab) to standard adjuvant therapy in patients with triple negative breast cancer. Patients were randomized to receive either standard chemotherapy (anthracycline +/- taxane or taxane only), or standard chemotherapy given concurrently with 1 year of Avastin (5mg/kg/week dosing equivalent i.v.). The anticipated time on study treatment was 3-12 months, and the target sample size was 500+ individuals.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Standard adjuvant chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label 2-arm Study to Evaluate the Impact of Adjuvant Bevacizumab on Invasive Disease Free Survival in Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • Percentage of Participants With Overall Survival (OS) Events [ 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. Percentage of participants with and without Overall Survival events by the time of data cutoff is presented.

  • 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: Up to 18 months for AEs and Up to 49 months for SAEs ] [ 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.



Enrollment: 2591
Study Start Date: December 2007
Estimated Study Completion Date: January 2015
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bevacizumab and chemotherapy
bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
Drug: bevacizumab [Avastin]
5 mg/kg/week dosing equivalent intravenous (iv)
Drug: Standard adjuvant chemotherapy
As prescribed
Active Comparator: chemotherapy
Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.
Drug: Standard adjuvant chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528567

  Show 404 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00528567     History of Changes
Other Study ID Numbers: BO20289
Study First Received: September 11, 2007
Results First Received: February 28, 2013
Last Updated: September 17, 2013
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014