Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment for breast cancer. The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane (125mg/m2) Combined With Q3week Xeloda (1250mg/m2) in early operable (stage of T2-4N0-3M0) breast cancer. This study will be an open label non randomized, single arm, single center study.
The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is feasible and achieves high response rates. It is proposed that 50 patients will be enrolled in this study. The target population is women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic therapy. The primary objective of the trial is to determine the overall response rate. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
ORR(CR+PR)
To evaluate the efficacy of concurrent Abraxane and Xeloda as neoadjuvant regimen in terms of: ORR(CR+PR), downstaging rates in tumor size and axillary lymph node. Pathological Complete Response(pCR) defined by: defined as ypT0, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).
Time frame: Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment
Side Effects.
Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on.
Time frame: First Dose of Abraxane and Xeloda up to 24 months
Event Free Survival(DFS)
Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
Time frame: Time of Surgery up to 5 years
Overall Survival(OS)
Time from the first dose of Abraxane and Xeloda to death due to any cause
Time frame: First Dose of Abraxane and Xeloda up to 5 years
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