NCT01822314

Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer

Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer " ETNA (Evaluating Treatment With Neoadjuvant Abraxane)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 632 (actual)
• Sponsor: Fondazione Michelangelo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions at surgery.

Detailed description

In this study, eligible and consenting patients will be randomized to receive either 4 cycles of weekly abraxane (nab-paclitaxel) followed by 4 cycles of an anthracycline-containing regimen or 4 cycles of weekly paclitaxel followed by 4 cycles of an anthracycline-containing regimen.The anthracycline regimen (AC, EC or FEC) will be chosen by the investigator at the participating sites. Before randomization patients will be stratified according to Disease stage \[operable (tumor stage: T2N0-1; T3N0) and locally advanced (T3N1;T4, any N2-3)\] and Tumor subtype \[luminal B intermediate (HER2 negative, ER or PGR positive, Ki67 from 14% to 20%) vs luminal B high (HER2 negative, ER or PGR positive, Ki67 \>20%) vs triple negative tumors (HER2 negative, ER negative and PgR negative, Ki67 any value)\]. Tumor subtype will be confirmed at two selected referral laboratories. Neoadjuvant chemotherapy will be followed by definite surgery and irradiation as per international and local guidelines. During neoadjuvant chemotherapy patients will be assessed for safety and efficacy as detailed in the protocol. After definite surgery patients will be followed for approximately 10 years according to local procedures

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Abraxane	Abraxane at the dosage of 125 mg/m2 will be delivered over 30 minutes on week 1, 2 and 3 followed by 1 week rest. week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
DRUG	Paclitaxel	Paclitaxel at the dosage of 90 mg/m2 diluted in 250 mL of water for injection (WFI) over 1 hour given week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-09-01
• Completion: 2023-03-01
• First posted: 2013-04-02
• Last updated: 2024-03-07

Locations

67 sites across 6 countries: Australia, Germany, Italy, Russia, Singapore, Spain