A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer
NCT ID: NCT01149798
Last Updated: 2012-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2010-06-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abraxane and Cisplatin combination
Abraxane and Cisplatin combination
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xichun Hu
Dr
Principal Investigators
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Xichun Hu
Role: STUDY_CHAIR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, , China
Countries
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References
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Li Y, Zhao Y, Gong C, Xie Y, Hu X, Zhang J, Wang L, Zhang S, Cao J, Tao Z, Wang B. Cisplatin shows greater efficacy than gemcitabine when combined with nab-paclitaxel in metastatic triple-negative breast cancer. Sci Rep. 2019 Mar 5;9(1):3563. doi: 10.1038/s41598-019-39314-y.
Tang LC, Wang BY, Sun S, Zhang J, Jia Z, Lu YH, Di GH, Shao ZM, Hu XC. Higher rate of skin rash in a phase II trial with weekly nanoparticle albumin-bound paclitaxel and cisplatin combination in Chinese breast cancer patients. BMC Cancer. 2013 May 9;13:232. doi: 10.1186/1471-2407-13-232.
Other Identifiers
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Fudan BR2010-02
Identifier Type: -
Identifier Source: org_study_id