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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03647514
• Other study ID #: dingxwyh01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2018
• Source: Zhejiang Cancer Hospital
• Contact: Ding Xiaowen, Doc
• Phone: +86 13588054604
• Email: dingxw[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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