FEASIBILITY STUDY OF PREOPERATIVE TAC IN CONJUNCTION WITH THE DEVELOPMENT OF A STANDARD PROTOCOL FOR THE MANAGEMENT OF LOCALLY ADVANCED BREAST CANCER

FEASIBILITY STUDY OF PREOPERATIVE TAC (DOCETAXEL, DOXORUBICIN, CYCLOPHOSPHAMIDE) IN CONJUNCTION WITH THE DEVELOPMENT OF A STANDARD PROTOCOL FOR THE MANAGEMENT OF LOCALLY ADVANCED BREAST CANCER (XRP6976D/6164)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000099628

Enrollment

Registered

2005-08-09

Start date

2005-03-01

Completion date

2006-11-01

Last updated

2021-04-12

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 will be a single arm, multicentre study involving women diagnosed with non-metastatic locally advanced breast cancer. The study will assess the feasibility of developing a uniform approach with chemotherapy, surgery and radiation therapy in the treatment of locally advanced breast cancer. It will also define the rates of objective clinical response and complete pathological response following 6 cycles TAC. Further, the accuracy of breast MRI and PET in predicting extent of breast cancer in the pathological examination of the surgical specimen will be assessed.

Interventions

6 cycles of TAC chemotherapy given pre-operatively and in responding patients, followed by surgery then radiation therapy.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Breast cancer T3Nany, T4Nany, N2 or N3 M0, ECOG performance status 0-2, Normal cardiac function.

Exclusion criteria

No metastases, Peripheral neuropathy > grade 2.

Outcome results