Phase II study of Paclitaxel and Epirubicin as Neoadjuvant Treatment for locally advanced Breast Cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000786493

Acronym

NAB

Enrollment

Registered

2016-06-16

Start date

2004-08-16

Completion date

2008-10-13

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 phase II study will determine whether the combination of Paclitaxel and Epirubicin can be used safely in the neoadjuvant setting in women with locally advanced breast cancer. The study will determine whether, in a multi-centre setting, the activity of this combination is maintained with acceptable toxicity. The study will also determine the disease free survival and overall survival in patients with locally advanced breast cancer, treated with neoadjuvant Paclitaxel and Epirubicin followed by definitive local surgery and radiotherapy and adjuvant Cyclophosphamide Methotrexate Fluorouracil.

Interventions

Neoadjuvant therapy on day 1 of each cycle for 4 cycles (cycle duration is 3 weeks) Epirubicin 90mg/m2 intravenously Paclitaxel 175 mg/ m2 intravenously Surgery Surgical review 2-3 weeks after completion of neoadjuvant chemotherapy, if operable surgery planned for within the next week. Timing based on surgeon availability. Surgery performed by specialist Breast Endocrine Surgical Unit. With larger tumours I.e. >5 cm original size, mastectomy recommended. Axillary dissection recommended for all patients. The duration of the surgical procedure is dependent on the tumour size, complexity of presentation and the procedure used. Adjuvant chemotherapy will commence when patient is deemed by their treating Medical Oncologist to have fully recovered from surgery. Usual time frame anticipated to be 4-6 weeks post-operatively. Adjuvant therapy (CMF) on days 1 and 8 of each cycle for 4 cycles (cycle duration is 4 weeks) Cyclophosphamide 600 mg/m2 intravenously Methotrexate 40 mg/ intravenously Fluorouracil 600mg/m2 intravenously Radiotherapy Radiotherapy to chest wall/breast including supraclavicular node. Can begin any time after completion of the 1st cycle of CMF. Radiotherapy is planned for all patients and anticipated to commence no earlier than 2nd cycle of CMF chemotherapy, at the discretion of the treating Radiation Oncologist. Radiotherapy administered, including the dose, frequency and duration and any other relevant parameters at the discretion of the treating Radiation Oncologist. Hormonal therapy Tamoxifen 20mg orally per day administered to patients with ER +ve cancers to commence following the completion of all chemotherapy and radiotherapy. Planned duration of Tamoxifen therapy is 5 years. Patient compliance is monitored by patient self-report of dosing to treating Medical Oncologist.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Female aged 18 years or over with histological or cytologically confirmed locally advanced breast cancer. T3-4 Nx, Tx N2-3 2. No evidence of metastatic disease. 3. Normal cardiac function as determined by left ventricular injection fraction of greater that 50 % (gated heart pool scan or echocardiogram). 4. ECOG performance status of 0 or 1. 5. Must give written in form consent prior to commencement of any specific studies and any starting specific treatment. 6. Patients must be willing and able to comply with the protocol for the duration of the study.

Exclusion criteria

1. Presence of metastatic disease. 2. Pregnant women or breast feeding mothers. 3. Women of child bearing potential who are unable or unwilling to use contraception. 4. Patients with a history of significant cardiac disease. 5. Patients with a history of significant neuropathy. 6. Patients with base line laboratory values with neutrophils less than 1.5 x 109/L, platelet count less than 100 x 109/L, serum creatinine greater than 1.5 x upper normal limit, serum bilirubin greater than 1.5 x upper normal limit, serum ALT or AST greater than 2.5 x upper normal limit, serum alkaline phosphatase greater than 2.5 x upper normal limit. 7. No patients with any prior malignancy other than completely excised basal cell carcinoma of the skin or completely resected cervical carcinoma in-situ. 8. Patients with any other uncontrolled medical condition or psychiatric condition deemed by the treating doctor to be unsuitable for treatment protocol.

Outcome results