Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer

NCT03647514 | Unknown

• 1 other identifier: dingxwyh01
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

neoadjuvant chemotherapy; Abraxane; Xeloda

Outcome Measures

Primary Outcomes (1)

• 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).

  Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment

Secondary Outcomes (3)

• Side Effects.

  First Dose of Abraxane and Xeloda up to 24 months

• Event Free Survival(DFS)

  Time of Surgery up to 5 years

• Overall Survival(OS)

  First Dose of Abraxane and Xeloda up to 5 years

Study Arms (1)

Abraxane Combined With Xeloda

EXPERIMENTAL

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.

Drug: Abraxane; Drug: Xeloda

Interventions

Abraxane DRUG

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.

Abraxane Combined With Xeloda

Xeloda DRUG

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.

Abraxane Combined With Xeloda

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of informed consent
• Women and men at least 18 years of age or older.
• Pathological confirmation of breast cancer
• Tumor stage(TNM):T2-4N0-3M0
• No evidence of distant metastasis
• Adequate bone marrow, hepatic, and renal function
• Measurable disease as per RECIST criteria
• Karnofsky≥70
• Laboratory criteria:
• PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ding Xiaowen, Doc

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ding Xiaowen, Doc

CONTACT

+86 13588054604; dingxw@zjcc.org.cn

Ding Yuqin

CONTACT

+86 13588255651; 13588255651@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: August 27, 2018
• Study Start: December 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share