Primary Breast Cancer Clinical Trial
Official title:
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)
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.
Primary Objective To compare the pathologic complete response (pCR) rate in the breast
(ypT0/is ypN0/+) in patients with operable Triple Negative or luminal B/HER2 normal breast
cancer treated with either cabazitaxel or weekly paclitaxel.
Secondary Objective To assess
- pCR rates per arm separately for the stratified subpopulations.
- Objective response rate (ORR) in the breast according to WHO criteria.
- pCR rate defined as ypT0 ypN0.
- pCR rate defined as ypT0/is ypN0.
- pCR rate in the axillary lymph nodes (ypN0).
- To determine the pCR rate and local recurrence free survival (LRFS) in patients with a
clinical complete response (cCR) and a negative core biopsy before surgery.
- Breast conservation surgery rate.
- To assess the toxicity (NCI CTCAE V4.03) and compliance in both arms.
- Invasive loco-regional recurrence free survival (LRRFS), distant-disease-free survival
(DDFS), invasive disease-free survival (IDFS), and overall survival (OS).
- To explore the biomarkers and profiles potentially predicting response to treatment.
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