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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Abraxane; Drug: Xeloda

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Abraxane Combined With Xeloda; 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; 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: Xeloda; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 of Surgery up to 5 years
Side Effects.	Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on.	First Dose of Abraxane and Xeloda up to 24 months
Overall Survival(OS)	Time from the first dose of Abraxane and Xeloda to death due to any cause	First Dose of Abraxane and Xeloda up to 5 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Ding Xiaowen, Doc, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; Xeloda; Abraxane
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Albumin-Bound Paclitaxel
• Other Study ID Numbers: dingxwyh01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No