Paclitaxel and Epirubicin as neoadjuvant systemic treatment for locally advanced breast cancer

A phase II study of Paclitaxel and Epirubicin, as neoadjuvant systemic treatment, for women with locally advanced breast cancer to assess response rates

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000307909

Enrollment

Registered

2011-03-23

Start date

2004-08-16

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 study is looking at the combination of the drugs Paclitaxel and Epirubicin used as neoadjuvant systemic treatment for women with locally advanced breast cancer in order to assess response rates Who is it for? You may take part in this study if you are a female aged 18 years or over and have a confirmed diagnosis of locally advanced breast cancer (cancer that is considered inoperable by your treating surgeon). Trial Details Participants in this study will receive Neoadjuvant (before surgery) chemotherapy with Paclitaxel and Epirubicin. The schedule of treatment will involve the drug Paclitaxel given at a dose of 175mg per m2 intravenously, and Epirubicin 90mg per m2 given intravenously given once every 3 weeks for a total of 4 doses before surgery (and an overall total of 12 weeks of treatment) The aim of this study is to see how a combination of 2 chemotherapeutic drugs - Paclitaxel and Epirubicin, is tolerated in women with locally advanced breast cancer. We also expect to see how effective this combination is in the treatment of this condition.

Interventions

Neoadjuvant chemotherapy with Paclitaxel and Epirubicin. Schedule: Paclitaxel 175mg per m2 intravenously, Epirubicin 90mg per m2, intravenously given once every 3 weeks for a total of 4 doses before surgery ( total of 12 weeks of treatment)

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

Women aged 18 years or over with histological or cytologically confirmed locally advanced breast cancer. T3-4 Nx, Tx N2-3

Exclusion criteria

Presence of metastatic disease.

Outcome results