Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)

Any prior treatment for primary breast cancer including radiation therapy

History of ipsi/ or contra-lateral invasive breast cancer

Locally advanced disease including N3 and metastatic disease

Patients in the following stages of disease are not allowed: cT4

Prior malignancy without being disease-free for more than 5 years (except carcinoma in situ of the cervix or other in situ cancer (e.g. bladder cancer) and adequately treated basal cell carcinoma of the skin.

Clinically significant (i.e. active) cardiovascular disease, including cerebrovascular accident (≤6 months before enrolment), myocardial infarction, arterial thrombotic events (≤6 months before enrolment), unstable angina pectoris, New York Heart Association (NYHA) ≥ grade 2 congestive heart failure and/or hypertension, serious cardiac arrhythmia requiring medication during the study and that might interfere with regularity of the study treatment, or not controlled by medication

Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or to comply with the study procedures or interfere with interpretation of study results (such as significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures).

Active infection.

Sex hormones. Prior treatment must be stopped before study entry.

Inability and unwillingness to comply with study visits, treatment, testing, and to comply with the protocol.

Administration of any live virus vaccine within 8 weeks preceding study entry.

Use of any investigational agent within 30 days of administration of the first dose of study drug or concurrent treatment on another clinical trial

Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible

Pregnancy or breastfeeding women

Patients with childbearing potential who do not agree to use accepted and effective method of contraception (barrier methods, intrauterine contraceptive devices, sterilization) during the study treatment period and following a period of 6 months after the last study drug administration.

History of hypersensitivity (grade ≥ 3) to polysorbate 80 or any study drugs or excipients

Concurrent or planned treatment with potent strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a two-week wash-out period is necessary for patients who are already on these treatments) (see Appendix 3)

Contraindications to the use of corticosteroid treatment

Symptomatic peripheral neuropathy grade ≥ 2 (National Cancer Institute Common Terminology Criteria \[NCI CTCAE\] v.4.03).

What this study is about