A clinical trial of neoadjuvant taxane chemotherapy for women with locally advanced breast cancer

Phase 2

Active, not recruiting

• Conditions: ocally advanced breast cancer; Locally advanced breast cancer; Cancer - Breast

• Registration Number: ACTRN12606000305527
• Lead Sponsor: The Cancer Council Victoria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Pre and post menopausal women with histologically proven locally advanced breast cancer as assessed by at least two clinicians ie surgeon &/or medical oncologist &/or radiation oncologist (UICC guidelines disease ranging between T3 and N2 to T4c and N1)2. Diagnosis of invasive adenocarcinoma is confirmed by core biopsy. A fine needle aspirate is acceptable but not encouraged3. Axillary lymph nodes clinically examined and may contain invasive tumour; may be fixed to one another or other structures4. The determination of oestrogen (ER) and progresterone (PgR) receptors is mandatory and results must be known by the end of chemotherapy to determine if hormonal therapy is indicated. ER and/or PgR are considered positive if > or = 1% of cells stain positively regardless of staining intensity, using immunohistochemistry5. All subjects should be evaluated at baseline and negative for distal and regional metastatic disease6. All subjects must be fit for and agree in principle to mastectomy and axillary dissection prior to study entry7. Subjects must be < or = 70 yrs of age8. Adequate renal and liver function and blood counts9.Left ventricular efection fraction (LVEF) must be normal (>50%) and electrocardiography (ECG) must not preclude anthracycline use.10.The subject must be able to give written informed consent according to the rules at each institution. The human rights Declaration of Helsinki must be the basis for the inclusion of patients.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to clinical response[];Pathologic response rate[];Time to local and systemic progression[]

Secondary Outcome Measures

Name	Time	Method
Survival time[From first diagnosis.];Quality of life[];Toxicities[]