Phase 3
Completed N=494
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
Source: ClinicalTrials.gov NCT01250379 ↗Enrolled (actual)
494
Serious AEs
29.8%
Results posted
Jun 2015
Primary outcomePrimary: Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) — 88.7; 93.9 percentage of participants
Summary
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) |
88.7; 93.9 | — |
| PRIMARY Second-Line PFS |
4.2; 6.3 | 0.0204 sig |
| PRIMARY Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 |
40.7; 54.2 | — |
| PRIMARY Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 |
16.9; 24.2 | — |
| PRIMARY Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 |
9.9; 11.0 | — |
| PRIMARY Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 |
6.4; 6.5 | — |
| SECONDARY Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) |
2.1; 4.9; 4.7; 6.7; 3.9; 5.1 | 0.0088 sig |
| SECONDARY Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013) |
16.8; 20.9 | 0.3457 |
| SECONDARY Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) |
1.1; 0.5; 15.7; 20.3; 33.5; 48.9 | — |
| SECONDARY Duration of Second-Line Objective Response (Data Cutoff 20 December 2013) |
10.6; 8.3 | 0.9825 |
| SECONDARY Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) |
96.7; 100.0; 69.0; 72.8; 60.9; 40.8 | — |
| SECONDARY Percentage of Participants With Third-Line PFS According to RECIST v1.1 |
94.3; 96.1 | — |
| SECONDARY Third-Line PFS |
2.9; 3.8 | 0.1080 |
| SECONDARY Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1 |
71.7; 83.4 | — |
| SECONDARY Second- and Third-Line PFS |
10.7; 12.8 | 0.1349 |
| SECONDARY Percentage of Participants With Second- and Third-Line Tumor Progression |
67.2; 75.3 | — |
| SECONDARY Time to Second- and Third-Line Tumor Progression |
11.2; 13.3 | 0.0744 |
| SECONDARY Percentage of Participants Who Died |
63.2; 66.0 | — |
| SECONDARY Overall Survival (OS) |
18.7; 19.7 | 0.7253 |
| SECONDARY Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 |
85.2; 90.4; 68.6; 72.4; 52.8; 54.9 | — |
| SECONDARY Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) |
60.3; 64.3; 36.4; 34.8; 0.5; 0.4 | — |
| SECONDARY Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) |
0.6806; 0.6725; 0.6953; 0.6515; 0.7496; 0.6534 | — |
| SECONDARY Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) |
-0.0103; -0.0370; 0.0387; -0.0508; -0.0884; -0.0878 | — |
| SECONDARY Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) |
66.5; 63.4; 69.3; 66.5; 67.3; 66.4 | — |
| SECONDARY Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) |
-2.0; 2.0; -0.2; 2.0; -5.1; -1.3 | — |
| SECONDARY Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) |
20.621; 20.253; 20.722; 20.674; 14.847; 15.062 | — |
| SECONDARY Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) |
-1.281; -1.289; 0.356; 0.707; 0.408; 1.024 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients, >/= 18 years of age
- Histologically confirmed HER2-negative breast cancer
- Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
- Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
- ECOG performance status 0-2
- At least 28 days since prior radiation therapy or surgery and recovery from treatment
Exclusion Criteria
- Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
- Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
- Inadequate renal function
- Clinically relevant cardio-vascular disease
- Known CNS disease except for treated brain metastases
- Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT01250379). 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.