N/A
N=111
A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Participants With HER 2-Negative Aggressive Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02613208 ↗Enrolled (actual)
111
Serious AEs
33.3%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants With Clinical Benefit — 53; 20; 5; 7 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Bevacizumab (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Benefit |
53; 20; 5; 7 | — |
| SECONDARY Percentage of Participants With Overall Response as Assessed Using RECIST v1.1 |
35; 38; 2; 10 | — |
| SECONDARY Progression Free Survival (PFS) as Assessed Using RECIST v1.1 |
17.38; 5.49 | — |
| SECONDARY Overall Survival |
NA; 13.01 | — |
| SECONDARY Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4 |
28; 45; 6; 6 | — |
| SECONDARY Optimal Cut-off for Clinical Benefit |
0.5 | — |
| SECONDARY Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups |
14; 27; 23; 21 | — |
| SECONDARY PFS as Assessed Using RECIST v1. in Prognostic Groups |
22.60; 8.05 | — |
| SECONDARY Mean CTC Count Levels |
91.6; 3.9 | <0.001 sig |
| SECONDARY Mean Carcinoembryonic Antigen (CEA) Levels |
46.5 | — |
| SECONDARY Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level |
277.8 | <0.001 sig |
Summary
This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
Eligibility Criteria
Inclusion Criteria
- Participants with HER2-negative metastatic breast cancer. Mandatory to have the HER2/estrogen receptor (ER)/progesterone receptor (PR) status
- Participant who met criteria for first-line treatment with chemotherapy plus bevacizumab (standard doses) by local, regional or national guidelines or authorities
- Participants with measurable disease (RECIST criteria v1.1) or participants with no measurable but assessable disease
- Molecular phenotype as triple negative metastatic breast cancer; and ER-positive tumors need to fulfill at least one of the two clinical criteria: metastatic relapse on adjuvant endocrine therapy or progression to at least one prior line of endocrine therapy for advanced disease; or aggressive disease criteria (at least two criteria): taxane based regimen in the (neo) adjuvant setting; metastatic relapse within 2 years from the end of chemotherapy for early breast cancer; liver metastasis; three or more organs with metastatic involvement; symptomatic visceral disease
- Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria
- Participant has received prior chemotherapy for metastatic disease
- Participant requiring major/minor surgery within 3 weeks prior to administration of the first dose of study treatment
- Participant has received an investigational therapy within 4 weeks prior to study entry
- Participant has known symptomatic brain metastases
- Participant with non-measurable or assessable disease: exclusive blastic bone disease; pleural, pericardial or abdominal effusion as only evidence of disease
- Participant in chronic daily treatment with corticosteroids (doses greater than [>]10 milligrams per day [mg/day] of methylprednisolone or equivalent), except inhaled steroids
- Pregnant or breastfeeding participant
- Women of childbearing potential who are not using hormonal contraceptives or highly effective birth control during the study
- Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Participant with significant renal, hematological or liver function alteration according to investigator's criteria
- Participant has serious medical risk factors involving any of the major organ systems
Data sourced from ClinicalTrials.gov (NCT02613208). 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.