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) - SOLTI NEOPARP

Phase 1

• Conditions: eoadjuvant TNBC; MedDRA version: 12.1Level: LLTClassification code 10057654Term: Breast cancer female

• Registration Number: EUCTR2010-018960-17-DE
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-07
• Last Update Posted: 29 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Histologically confirmed operable Stage II-IIIA invasive breast cancer eligible for definitive surgery and ER-negative, PgR-negative and HER2 non-overexpressing by 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 MRI.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate bone marrow reserve.
- Adequate liver and renal function.
- Age =18 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 =2 as per National Cancer Institute
- Common Toxicity Criteria for Adverse Event (NCI CTCAE) at randomization.
- Any history of medical (e.g., cardivascular, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified