Table 4

Overview of the main ongoing or closed but still not reported clinical trials that involve taxanes

Trial ID

Design

Patient characteristics and end-points


Trials not recruiting or completed

NO17629

AC × 4 → D100 × 4 versus AC × 4 → D75X × 4

1,810 node-positive and high-risk node-negative patients

NSABP B-38

ACD × 6 versus AC × 4 (q2w) → P × 4 (q2w) versus AC × 4 (q2w) → PG × 4 (q2w)

4,800 node-positive patients; DFS (primary); OS, recurrence and distant recurrence-free interval and toxicity (secondary)

CT/04.22

FEC × 4 (q2w) → D × 4 (q2w) versus FEC × 4 (q2w) → P × 4 (q2w)

478 node-positive patients; DFS (primary); OS, recurrence rate, toxicity and QoL (secondary)

GEICAM 2003-10

EC × 4 → D × 4 versus ED × 4 → X × 4

1,382 node-positive patients; DFS (primary); OS, toxicity, QoL, SNP predictors and molecular markers (secondary)

GEICAM 2003-02

FAC × 6 versus FAC × 4 → P × 8w

1,920 high risk node-negative patients; DFS (primary); OS, toxicity, QoL and prognostic gene profile (2)

Trials actively recruiting

CALGB-40101

AC × 4 (q2w) versus AC × 6 (q2w) versus P × 4 (q2w) versus P × 6 (q2w)

4,646 with 0 to 3 positive nodes patients; DFS (primary); OS, local control, time to distant metastasis, toxicity, amenorrhea, MDR1 haplotype effect, CYP polymorphism effect

LMU-ADEBAR

EF (d1, d8) C (oral d1–14) × 6 (q4w) versus EC (d1, d21, d42, d63) → D (d84, d105, d126,147)

446 node-positive patients; time to progression (primary); OS, toxicity and QoL (secondary)

SWOG-S0221

AC × 6 (q2w) → P × 6 (q2w) versus AC × 6 (q2w) → P × 12(w) versus AC × 15 (Aw, C oral d1–7) → P × 6 (q2w) versus AC × 15 (Aw, C oral d1–7) → P × 12(w)

4,500 node-positive and high-risk node-negative patients; DFS (primary); OS, toxicity and prognostic markers (secondary)

CT/01.04

D75 × 4 → E90 × 4 versus E75D75 × 6

724 high-risk node-negative patients; DF interval (primary); OS and safety (secondary)

USO 06090

TAC × 6 versus TC × 6

HER2 negative and node-positive and high-risk node-negative patients; DFS (primary)


Overview of the main ongoing or closed but still unreported clinical trials that involve taxanes in their design as early breast cancer adjuvant treatment. The first part of the table includes trials that are active but not recruiting or have already completed, and the second part of the table is composed of clinical trials with active recruitment on August 2008, according to the National Cancer Institute Clinical Trial Database [71]. A, doxorubicin; C, cyclophosphamide; D, docetaxel; DFS, disease-free survival; E, epirubicin; F, 5-fluorouracil; G, gemcitabine; OS, overall survival; P, paclitaxel; QoL, quality of life; w, weeks; X, capecitabine.

López-Tarruella and Martín Breast Cancer Research 2009 11:204   doi:10.1186/bcr2226