Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)
18 Years
N/A
Female
Breast Cancer Female
Trial Information
Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)
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 infusions for Arm B. In all study arms, treatment will be given until
definitive surgery, the first sign of disease progression, unacceptable toxicity or
withdrawal of patient consent.
Definitive surgery will be performed within 2 to 4 weeks after the last dose of study
treatment.
Patients who complete all the study treatment or who withdraw consent or experience
intolerable toxicity will undergo surgery according to local practices.
The cut-off date for the primary analyses will be 30 days after the last study treatment
administration or the date of the definitive surgery, whichever comes last.
The maximum follow up for each individual patient will be until death or 5 years after the
definitive surgery date whatever happens first.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological Complete Response (pCR) rate defined as the complete absence of invasive carcinoma on histological examination of the breast at the time of definitive surgery and confirmed by blinded centralized review
Outcome Time Frame:
at the time of definitive surgery
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Spain: Ministry of Health
Study ID:
TCD11419
NCT ID:
NCT01204125
Start Date:
September 2010
Completion Date:
February 2017
Related Keywords:
- Breast Cancer Female
- Breast Neoplasms
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