A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer

NCT01149798 | Completed Phase 2

• 1 other identifier: Fudan BR2010-02
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancer; combined chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall response rates (ORR) of abraxane and cisplatin combination therapy

  2months

Secondary Outcomes (3)

• Progression free Suivial (PFS)

  6 months

• Number of adverse event

  2 months

• Overrall Survival (OS)

  12 months

Study Arms (1)

Abraxane and Cisplatin combination

EXPERIMENTAL

Abraxane and Cisplatin combination

Drug: Abraxane and Cisplatin combination

Interventions

Abraxane and Cisplatin combination DRUG

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.

Also known as: Abraxane, Cisplatin

Abraxane and Cisplatin combination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must fulfill all of the following conditions or characteristics in order to be considered for study enrollment:
• 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.
• At least one measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
• Histopathologically or cytologically confirmed breast cancer.
• Female at an age of ≥18 years.
• 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.
• 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
• ECOG performance status of 0, 1 or 2.

You may not qualify if:

• Pregnant or breast-feeding women.
• Positive serum pregnancy test.
• Unwilling to use a medically acceptable form of contraception, except for those who were surgically sterile or at least 1 year postmenopausal.
• 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.
• Meningeal metastases.
• Radiotherapy within the 4 weeks preceding study treatment start.
• Incomplete recovery from the effects of major surgery.
• Prior hormonal treatment allowed but must be discontinued 14 days prior to study entry.
• Participation in any investigational drug study within 4 weeks preceding treatment start.
• Blood transfusions or growth factors to aid hematological recovery within 2 weeks prior to study treatment start.
• Significant medical condition that would make treatment or follow-up on this protocol difficult or problematic in the opinion of the treating oncologist.
• 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.
• Serious uncontrolled intercurrent infections.
• Poor compliance.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (2)

• 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.

  PMID: 30837503 DERIVED

• 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.

  PMID: 23659317 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Xichun Hu

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 24, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

CN (1)