NCT01779479

Randomized, Open-label, Phase II Study Comparing the Efficacy and the Safety of Cabazitaxel Versus Weekly Paclitaxel Given as Neo-adjuvant Treatment in Patients With Operable Triple Negative or Luminal B/HER2 Normal Breast Cancer (GENEVIEVE)

Completed Phase 2 Last updated 31 July 2017

What this trial tests

Phase 2 trial testing Cabacitaxel in Primary Breast Cancer in 333 participants. Completed in 1 February 2016.

Timeline

1 February 2013

Primary endpoint
1 August 2015

1 February 2016

Quick facts

Lead sponsor	GBG Forschungs GmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	333
Start date	1 February 2013
Primary completion	1 August 2015
Estimated completion	1 February 2016
Sites	1 location across Germany

Drugs / interventions tested

• Cabacitaxel — full drug profile →
• Paclitaxel — full drug profile →

Conditions studied

• Primary Breast Cancer — all drugs for Primary Breast Cancer →

Sponsor

GBG Forschungs GmbH — full company profile →

Who can join

18 and older, female only, with Primary Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• pathologic complete response (pCR) rate
  Time frame: 15 months

Sponsor's own description

Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel and was selected for development based on a better antiproliferative activity on resistant cell lines than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus prednisone in docetaxel pre-treated hormone refractory metastatic prostate cancer patients leading to registration of the compound. It showed a favorable toxicity profile with an interestingly low rate of alopecia. In the Genevieve study it will be compared against weekly paclitaxel which is currently most widely used treatment of breast cancer patients. A head-to-head comparison in the neoadjuvant setting will allow a rapid and precise comparison of efficacy and tolerability of cabacitaxel versus paclitaxel to decide in how far further development of this taxoid in breast cancer is reasonable.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomised, open-label, phase II study comparing the efficacy and the safety of cabazitaxel versus weekly paclitaxel given as neoadjuvant treatment in patients with operable triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE).
   Kümmel S, Paepke S, Huober J, Schem C, et al · · 2017 · cited 16× · PMID 28768217 · DOI 10.1016/j.ejca.2017.06.037
2. Long-term outcomes of a randomized, open-label, phase II study comparing cabazitaxel versus paclitaxel as neoadjuvant treatment in patients with triple-negative or luminal B/HER2-negative breast cancer (GENEVIEVE).
   Meyer-Wilmes P, Huober J, Untch M, Blohmer JU, et al · · 2024 · cited 5× · PMID 38663168 · DOI 10.1016/j.esmoop.2024.103009