Study of changes in cancer tissue induced by treatment with bevacizumab in metastatic breast cancer

Study of molecular changes induced by treatment with bevacizumab in metastatic breast cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000904279

Enrollment

Registered

2009-10-19

Start date

2009-10-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial will try to identify molecular changes in tumor tissue induced by treatment with bevacizumab

Interventions

Biopsy of tissue from recurrent or metastatic breast cancer (only skin, lymph node, breast tumor biopsies allowed) on day 0, administration of bevacizumab 10mg/kg on day 1 (intravenously infused over 90 min) and re-biopsy on day 14.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

histologically proven metastatic breast cancer, locally accessible disease (breast tumor, skin mets, lymph node mets), Performance status (PS) 0-1, normal liver and kidney function

Exclusion criteria

history of thrombotic disease, uncontrolled brain metastases, pregnancy, lactation, prior bevacizumab exposure, recent surgery (within 4 weeks), active bleeding, active infection, unhealed wound, use of anticoagulants in therapeutic doses

Outcome results