N/A
Completed N=227
An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer
Source: ClinicalTrials.gov NCT01461044 ↗Enrolled (actual)
227
Serious AEs
6.2%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis — 73.1; 80.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis |
73.1; 80.6 | — |
| PRIMARY Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis |
68.7; 56.7 | — |
| PRIMARY Disease-Free Interval |
51.0; 28.0 | — |
| PRIMARY Mean Age at the Time of Local or Metastatic Progression |
54.5; 55.5 | — |
| PRIMARY Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression |
31.6; 18.6; 68.4; 81.4 | — |
| PRIMARY Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression |
46.7; 54.7; 43.4; 37.7; 9.0; 7.5 | — |
| PRIMARY Mean Body Weight at the Time of Local or Metastatic Progression |
66.8; 66.2 | — |
| PRIMARY Mean Height at the Time of Local or Metastatic Progression |
161.7; 164.1 | — |
| PRIMARY Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression |
25.6; 24.7 | — |
| PRIMARY Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression |
1.5; 4.6 | — |
| PRIMARY Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression |
63.7; 46.3; 34.1; 29.9; 35.6; 17.9 | — |
| PRIMARY Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression |
56.7; 71.2; 43.3; 28.8 | — |
| PRIMARY Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression |
64.4; 43.3 | — |
| PRIMARY Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression |
92.2; 0; 4.4; 93.0; 3.3; 7.0 | — |
| PRIMARY Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression |
64.4; 0; 31.1; 93.0; 4.4; 7.0 | — |
| PRIMARY Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression |
64.0; 0; 31.4; 0; 3.5; 0 | — |
| PRIMARY Percentage of Participants With HR Status at the Time of Local or Metastatic Progression |
98.9; 0; 1.1; 100 | — |
| PRIMARY Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression |
100; 100 | — |
| PRIMARY Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression |
22.8; 7.5; 5.1; 5.0; 3.8; 17.5 | — |
| PRIMARY Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression |
3.8; 5.3; 11.3; 13.2; 85.0; 81.6 | — |
| PRIMARY Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression |
41.5; 59.7 | — |
| PRIMARY Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression |
24.2 | — |
| SECONDARY Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) |
28.2; 33.9; 58.0; 45.8 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death |
79.3; 80.6 | — |
| SECONDARY Progression-Free Survival |
25.3; 21.2 | — |
| SECONDARY Time to Progression |
25.3; 21.2 | — |
| SECONDARY Percentage of Participants With Death |
37.8; 41.8 | — |
| SECONDARY Overall Survival (OS) |
57.2; 49.4 | — |
| SECONDARY Duration of Bevacizumab as First Line Treatment |
21.2; 18.6 | — |
| SECONDARY Percentage of Participants With Temporary Discontinuation |
28.1; 29.9 | — |
| SECONDARY Percentage of Participants With Reasons for Temporary Discontinuation |
34.2; 35.0; 34.2; 45.0; 15.8; 20.0 | — |
| SECONDARY Percentage of Participants With Definitive Discontinuation |
75.6; 88.1 | — |
| SECONDARY Percentage of Participants With Reasons for Definitive Discontinuation |
54.9; 58.6; 24.5; 24.1; 16.7; 15.5 | — |
| SECONDARY Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease |
25.0; 17.0 | — |
| SECONDARY Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab |
99.3; 98.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01461044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.