A study of intravenous vinorelbine and oral capecitabine in patients with advanced breast cancer

Phase II study of intravenous Vinorelbine (Navelbine) and Capecitabine (Xeloda) in patients with advanced breast cancer, assessing efficacy and toxicity

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000370505

Acronym

NavXel, BC-03-02

Enrollment

Registered

2003-12-17

Start date

2003-05-13

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 determine the safety and activity of giving two new drugs together in women with advanced breast cancer. Both of these drugs are active when given alone; giving them together may be better.

Interventions

Intravenous vinorelbine 25 mg/m2 day 1 and 8 and oral capecitabine 1000 mg/m2 days 1-14 every 21 days. Maximum 9 cycles.

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

Advanced/ metastatic breast cancer; maximum of 1 prior chemotherapy for metastatic cancer; at lteat `1 measurable lesion by RECIST; > 18 years; KPS > 80%; adequate organ function

Exclusion criteria

Life expectance <12 weeks; significant comorbidities; peripheral neuropathy > grade1; other invasive cancers; unable to swallow pills whole

Outcome results