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

• Sponsor: Zhejiang Cancer Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03647514
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Anticipated Duration (Months): 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Abraxane; Drug: Xeloda	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Dec 1, 2018
• Anticipated Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. ORR(CR+PR) [Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment]

   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).

Secondary Outcome Measures

1. Side Effects. [First Dose of Abraxane and Xeloda up to 24 months]

   Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on.

2. Event Free Survival(DFS) [Time of Surgery up to 5 years]

   Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.

3. Overall Survival(OS) [First Dose of Abraxane and Xeloda up to 5 years]

   Time from the first dose of Abraxane and Xeloda to death due to any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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≥100109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2ULN

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhejiang Cancer Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03647514
• Other Study ID Numbers: dingxwyh01
• First Posted: Aug 27, 2018
• Last Update Posted: Dec 10, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhejiang Cancer Hospital: neoadjuvant chemotherapy; Abraxane; Xeloda
• Additional relevant MeSH terms: Breast Neoplasms; Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Dec 10, 2018