Clinical trial NCT03647514: Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer
Official title: A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: neoadjuvant chemotherapy
Abraxane
Xeloda
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent
2. Women and men at least 18 years of age or older.
3. Pathological confirmation of breast cancer
4. Tumor stage(TNM):T2-4N0-3M0
5. No evidence of distant metastasis
6. Adequate bone marrow, hepatic, and renal function
7. Measurable disease as per RECIST criteria
8. Karnofsky≥70
9. Laboratory criteria:

PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN

Exclusion Criteria:

1. Presence of metastatic disease.
2. Inflammatory breast cancer.
3. Bilateral breast cancer.
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
5. other malignant tumors (concurrent or previous).
6. Pregnant woman.
7. Hypersensitive to any drug in Abraxane or Xeloda regimen or any ingredient of Abraxane or Xeloda.
8. Any severe systemic disease contraindicating chemotherapy

Primary outcomes:
measure: ORR(CR+PR)
timeFrame: Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment
Secondary outcomes:
measure: Side Effects.
timeFrame: First Dose of Abraxane and Xeloda up to 24 months
measure: Event Free Survival(DFS)
timeFrame: Time of Surgery up to 5 years
measure: Overall Survival(OS)
timeFrame: First Dose of Abraxane and Xeloda up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Ding Xiaowen, Doc
role: PRINCIPAL_INVESTIGATOR
References: