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A Phase III, Multicenter, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Paclitaxel (GT) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase III, Multicenter, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Paclitaxel (GT) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer


The previous phase II study showed that gemcitabine and cisplatin combination (GP) is an
effective regimen in triple negative breast cancer (TNBC). The potential therapeutic effects
of GP in advanced TNBC deserve further evaluation yet. Eligible patients are randomly
assigned to receive either GP or GT regimen to verify the hypothesis.


Inclusion Criteria:



1. Females with age between 18 and 70 years old

2. Histological proven unresectable recurrent or advanced breast cancer

3. 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.

4. 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

5. At least one measurable disease according to the response evaluation criteria in
solid tumor (RECIST)

6. Performance status not more than 1

7. All patients enrolled are required to have adequate hematologic, hepatic, and renal
function

8. Life expectancy greater than 12 weeks

9. No serious medical history of heart, lung, liver and kidney

10. Provision of written informed consent prior to any study specific procedures

11. Patients with good compliance

Exclusion Criteria:

1. 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)

2. Women of child-bearing potential, unwilling to use adequate contraceptive protection
during the course of the study

3. 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

4. Treatment with an investigational product within 4 weeks before the first treatment

5. 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

6. 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.

7. 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

8. Uncontrolled serious infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS (Progression Free Survival)

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Xichun Hu, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

Fudan BR2010-04

NCT ID:

NCT01287624

Start Date:

January 2011

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • triple negative breast cancer
  • fine line chemotherapy
  • Breast Neoplasms

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