Status:
COMPLETED
Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients
Lead Sponsor:
Sanofi
Collaborating Sponsors:
SOLTI Breast Cancer Research Group
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: \- to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly...
Detailed Description
Active study treatment will be given either as twice weekly administration (Day 1 and Day 4) or as weekly administration (Day 1) for a maximum of 24 infusions for Arm A and for a maximum of 12 infusio...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically confirmed Stage II-IIIA invasive breast cancer eligible for definitive surgery and Estrogen Receptor (ER)-negative, Progesterone receptor (PgR)-negative and Human epidermal growth factor receptor 2 (HER2) non-overexpressing by Immunohistochemistry (IHC) (0+, 1+) or fluorescence in situ hybridization (FISH negative, ratio \<1.8) or IHC (2+, 3+) /FISH-negative.
- The primary tumor must be \> 2cm in diameter measured by physical examination and mammography (mandatory) plus either echography or Magnetic Resonance Imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate bone marrow reserve
- Adequate liver and renal function.
- Age \> or = 18 years
- Exclusion criteria:
- Any prior treatment for primary breast cancer.
- Bilateral or multicentric breast cancer.
- Other primary tumors within the previous 5 years, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Pre-existing peripheral neuropathy grade \> or = 2 as per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) at randomization.
- Any history of medical (e.g., cardiovascular, uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results
- Pregnancy or breastfeeding women.
- Women of childbearing potential (\<2 years after the last menstruation) not using effective, non-hormonal means of contraception during the study and for a period of 6 months following the last administration of study drug.
- Requirement for radiation therapy concurrent with study anticancer treatment. Patients who require breast or chest wall radiation therapy after surgery are eligible.
- Known hypersensitivity to any of the study drugs or excipients
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01204125
Start Date
September 1 2010
End Date
February 1 2017
Last Update
March 22 2017
Active Locations (25)
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1
Investigational Site Number 250001
Besançon, France, 25030
2
Investigational Site Number 250004
Bordeaux, France, 33076
3
Investigational Site Number 250006
Bron, France, 69677
4
Investigational Site Number 250003
Paris, France, 75475