Phase 2
N=26
Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00428922 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen. — 14.3 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trastuzumab (Drug); Bevacizumab (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bhuvaneswari Ramaswamy
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen. |
14.3 | — |
| SECONDARY Changes in CTCs as Predictors of PFS and Clinical Benefit |
7 | — |
| SECONDARY Overall Clinical Benefit Rate (CR+PR+SD) |
69 | — |
| SECONDARY Changes in CECs as Predictors of PFS and Clinical Benefit |
— | — |
Summary
The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed breast cancer with evidence of metastatic disease
- HER2 3+ or FISH (fluorescent in situ hybridization)+
- Age ≥ 18 years
- No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.
- No prior chemotherapy in the metastatic setting.
Exclusion Criteria
- CNS (central nervous system) metastases
- Prior radiation therapy within the last 4 weeks
- Pregnant (positive pregnancy test) or lactating women
- Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.
Data sourced from ClinicalTrials.gov (NCT00428922). 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.