NCT01550848

Brief Summary

The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

February 27, 2012

Last Update Submit

September 8, 2015

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    8 weeks

Secondary Outcomes (1)

  • number of adverse events

    6 months

Study Arms (1)

Abraxane and Gemcitabine

EXPERIMENTAL

Abraxane and Gemcitabine

Drug: Abraxane and Gemcitabine

Interventions

Abraxane and GemcitabineDRUG

ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15 GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15

Also known as: Combined Chemotherapy
Abraxane and Gemcitabine

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female between 18 and 70 years old;
  • Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;
  • ECOG (Eastern Cooperative Oncology Group) 0\~1;
  • Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;
  • Got ICF (Informed Consent Form) before enrollment;
  • Life expectancy more than 12 weeks

You may not qualify if:

  • Pregnant or breast-feeding women or positive serum pregnancy test;
  • 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;
  • Participation in any investigational drug study within 4 weeks preceding treatment start;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 30837503DERIVED

  • Zhao Y, Lv F, Chen S, Wang Z, Zhang J, Zhang S, Cao J, Wang L, Cao E, Wang B, Hu X. Caveolin-1 expression predicts efficacy of weekly nab-paclitaxel plus gemcitabine for metastatic breast cancer in the phase II clinical trial. BMC Cancer. 2018 Oct 22;18(1):1019. doi: 10.1186/s12885-018-4936-y.

    PMID: 30348118DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound PaclitaxelGemcitabineAntineoplastic Combined Chemotherapy Protocols

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingAntineoplastic ProtocolsClinical ProtocolsTherapeuticsDrug TherapyDrug Therapy, Combination

Study Officials

  • Xichun Hu, MD;PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 12, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

June 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

CN(1)