Efficacy and Safety Study of Neoadjuvant Chemotherapy for Local Advanced Triple Negative Breast Cancer Patients

NCT01216124 | Unknown

• 1 other identifier: Fudan TNBC Neo CT
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The 10%-15% of breast carcinomas known to be 'triple negative (TN)' (not expressing HRs and not exhibiting overexpression Her2) constitutes 85% of all basal-like tumors, because it is based on three standard immunohistochemical biomarkers. In clinical routine, Docetaxel was widely indicated as first-line therapy for breast cancer patients in adjuvant or neoadjuvant settings. Oxaliplatin, trans-1-diaminocyclohexane-platinum, may offer advantages over other platinum agents. Oxaliplatin promotes formation of DNA adducts, preventing DNA replication and transcription and ultimately causing apoptosis. Oxaliplatin was more potent than cisplatin and the Oxaliplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. TNBC patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies. There was no report about Oxaliplatin in the chemotherapy setting for breast cancer patients. The investigators hypothesized that using Oxaliplatin adding to docetaxel would be feasible and active in patients with TNLABC because in vitro findings suggest synergism between the agents. This study was designed to investigate the efficacy and toxicity of oxaliplatin-based regimen as a neoadjuvant chemotherapy setting in triple negative local advanced breast cancer patients

Conditions

Triple Negative Local Advanced Breast Cancer

Keywords

triple negative local advanced breast cancer(TNLABC),neoadjuvant chemotherapy

Interventions

docetaxel oxaliplatin DRUG

docetaxel 75mg/m2 D1 oxaliplatin 130mg/m2 D2 1 cycle=21 days DO\*6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged from 18 to 65 years;
• Histologically or cytologically proven invasive unilateral breast cancer (regardless of the type);
• Initial clinical condition compatible with complete initial resection;
• No residual macro or microscopic tumor after surgical excision;
• Patient presenting one of the following criteria (reviewed before randomization by referent pathologist):
• Triple Negative(ER-PR-Her-2-) Hormone receptor negativity is defined as ER\<10%, PR\<10% (IHC), HER2 negativity is defined as IHC 0-1+, or \[IHC 2+ and FISH or CISH negative\].
• No clinically or radiologically detectable metastases (M0);
• No peripheral neuropathy \> 1;
• WHO Performance status (ECOG) of 0 or 1;
• Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin \> 9 g/dl);
• Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5 ULN,total bilirubin £ 1,5 ULN;
• Adequate renal function: serum creatinine £ 1.5 ULN;
• Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
• Adequate cardiac function, LEVF value \> 50% by Muga scan or echocardiography;
• Signed written informed consent.

You may not qualify if:

• Bilateral breast cancer or patient with controlateral DCIS;
• Any metastatic impairment, including homolateral sub-clavicular node involvement,regardless of its type;
• Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
• Luminal A, Luminal B and Her-2 overexpression
• Any clinically or radiologically suspect and non-explored damage to the controlateral breast;
• Previous cancer (excepted cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive controlateral breast cancer;
• Patients already included in another therapeutic trial involving an experimental drug;
• Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
• LEVF \< 50% (MUGA scan or echocardiography);
• Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (\>150/90), myocardial infarction or cerebral vascular accidents) within 6 months prior to randomization;
• Known prior severe hypersensitivity reactions to agents in this study
• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 8 weeks after treatment completion;
• \) Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase; 15) Women with a positive pregnancy test en enrollment or prior to study drug administration; 16) Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; 17) Individual deprived of liberty or placed under the authority of a tutor.

Sponsors & Collaborators

• Fudan University: lead
• Chinese Anti-Cancer Association: collaborator

Central Study Contacts

Zhimin Shao, MD, PHD

CONTACT

+862164175590; luona801379@hotmail.com

Fei Fei, MD

CONTACT

+862164175590; baketutu520@gmail.com

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Last Updated: October 7, 2010

Record last verified: 2009-09