NCT01287624

Brief Summary

This is a prospective, multi-center, open-labeled, randomized phase III clinical trial comparing overall response rate (ORR), progression free survival (PFS), overall survival (OS) and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine paclitaxel combination (GT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3 breast-cancer

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, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

January 31, 2011

Last Update Submit

March 19, 2015

Conditions

Breast Cancer

Keywords

triple negative breast cancerfine line chemotherapy

Outcome Measures

Primary Outcomes (1)

  • PFS (Progression Free Survival)

    6 weeks

Secondary Outcomes (1)

  • Objective Response Rate (ORR)

    6 weeks

Study Arms (2)

Gemcitabine,cisplatin

EXPERIMENTAL

GP (gemcitabine and cisplatin)

Drug: Gemcitabine,cisplatin

Gemcitabine, Paclitaxel

ACTIVE COMPARATOR

GT (gemcitabine and paclitaxel combination)

Drug: Gemcitabine, Paclitaxel

Interventions

Gemcitabine,cisplatinDRUG

Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1

Also known as: experimental arm
Gemcitabine,cisplatin
Gemcitabine, PaclitaxelDRUG

Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Paclitaxel 175 mg/m2, IV, 3h,D1

Also known as: control arm
Gemcitabine, Paclitaxel

Eligibility Criteria

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

You may qualify if:

  • Females with age between 18 and 70 years old
  • Histological proven unresectable recurrent or advanced breast cancer
  • Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (IHC) test. For patients with ER negative, PR negative, Her2 two plus, a negative Her2 gene amplification should be verified with FISH test. Her2 one plus may consider FISH verification.
  • No prior chemotherapy for metastatic breast cancer. Prior use of taxanes in the adjuvant/neoadjuvant setting is acceptable if completed 6 months prior to enrollment
  • At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST)
  • Performance status not more than 1
  • All patients enrolled are required to have adequate hematologic, hepatic, and renal function
  • Life expectancy greater than 12 weeks
  • No serious medical history of heart, lung, liver and kidney
  • Provision of written informed consent prior to any study specific procedures
  • Patients with good compliance

You may not qualify if:

  • Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
  • Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
  • Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previously administered radiotherapy
  • Treatment with an investigational product within 4 weeks before the first treatment
  • Symptomatic central nervous system metastases, except for patients with stable and asymptomatic brain metastases who have completed a course of cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
  • Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
  • Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
  • Uncontrolled serious infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

  • Zhang J, Lin Y, Sun XJ, Wang BY, Wang ZH, Luo JF, Wang LP, Zhang S, Cao J, Tao ZH, Wu J, Shao ZM, Yang WT, Hu XC. Biomarker assessment of the CBCSG006 trial: a randomized phase III trial of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer. Ann Oncol. 2018 Aug 1;29(8):1741-1747. doi: 10.1093/annonc/mdy209.

    PMID: 29905759DERIVED

  • Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, Yin YM, Wu CP, Jiang ZF, Wang XJ, Lou GY, Liu DG, Feng JF, Luo JF, Sun K, Gu YJ, Wu J, Shao ZM. Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):436-46. doi: 10.1016/S1470-2045(15)70064-1. Epub 2015 Mar 18.

    PMID: 25795409DERIVED

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

GemcitabineCisplatinPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Xichun Hu, MD,PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 1, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 23, 2015

Record last verified: 2015-03

Locations

CN(1)