A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Single Institutional Phase II Clinical Trial of Abraxane Combined With Cisplatin in Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149798
• Other study ID #: Fudan BR2010-02
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2010
• Last updated: August 5, 2012
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This phase II trial on the assumption that abraxane and cisplatin combination therapy is efficacy in metastatic breast cancer.

Description:

The rationales for the combination of Abraxane and cisplatin include that either drug has antitumor activity; they have different mechanisms; no cross-resistance are documented between them, and there have been some preclinical evidences indicating synergistic effects between the two agents. This phase II study will be undertaken to evaluate combination of cisplatin and weekly abraxane in terms of efficacy and safety in MBC patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject must fulfill all of the following conditions or characteristics in order to be considered for study enrollment:

1. Written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice.

2. At least one measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).

3. Histopathologically or cytologically confirmed breast cancer.

4. Female at an age of =18 years.

5. Prior taxane or platinum treatment allowed. However, the drug interval should be longer than 12 months in adjuvant/neo-adjuvant setting and three months in MBC patients who have obtained ORR with taxane- or platinum-containing regimens.

6. The lab values within 2 weeks prior to trial should meet:

• PLT =100,000/mm3

• ANC=2000/mm3

• HB=80g/L

• Total bilirubin < upper limit of normal level(UNL, < 1.5 x UNL for patients with liver metastasis)

• ALT/AST < 1.5 x UNL (< 2.5 x UNL for patients with liver metastasis)

• AKP < 5 x UNL (except for patients with bone metastasis)

• Serum creatinine < UNL

7. ECOG performance status of 0, 1 or 2.

8. A life expectancy of more than 3 months.

Exclusion Criteria:

1. Pregnant or breast-feeding women.

2. Positive serum pregnancy test.

3. Unwilling to use a medically acceptable form of contraception, except for those who were surgically sterile or at least 1 year postmenopausal.

4. Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling.

5. Meningeal metastases.

6. Radiotherapy within the 4 weeks preceding study treatment start.

7. Incomplete recovery from the effects of major surgery.

8. Prior hormonal treatment allowed but must be discontinued 14 days prior to study entry.

9. Participation in any investigational drug study within 4 weeks preceding treatment start.

10. Blood transfusions or growth factors to aid hematological recovery within 2 weeks prior to study treatment start.

11. Significant medical condition that would make treatment or follow-up on this protocol difficult or problematic in the opinion of the treating oncologist.

12. Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer.

13. Serious uncontrolled intercurrent infections.

14. Poor compliance.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Abraxane and Cisplatin combination
Abraxane will be given at 125 mg/m2, venous infusion within 30 minutes, administered on days 1, 8 and 15. Cisplatin at 75mg/m2, venous infusion for 120 minutes, will be administered on day 1.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rates (ORR) of abraxane and cisplatin combination therapy		2months	No
Secondary	Progression free Suivial (PFS)		6 months	Yes
Secondary	Number of adverse event		2 months	Yes
Secondary	Overrall Survival (OS)		12 months	Yes