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A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer

Phase 2
18 Years
70 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer

Triple-negative breast cancer is associated with less treatment choices and shorter overall
survival. Both vinorebine and oxaliplatin are effective in metastatic breast cancer. The
investigators designed this trial to evaluate the combination of these two drugs in
pretreated metastatic triple-negative breast cancer.

Inclusion Criteria:

1. Females with age between 18 and 70 years old

2. ECOG performance between 0-2

3. Life expectancy more than 3 months

4. Histological proven unresectable recurrent or advanced breast cancer

5. 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.

6. No more than 2 chemotherapy for metastatic breast cancer.

7. At least one measurable disease according to the response evaluation criteria in
solid tumor (RECIST1.1)

8. No anticancer therapy within 4 weeks

9. No neuropathy more than grade I

10. Adequate hematologic, hepatic, and renal function,No serious medical history of
heart, lung, liver and kidney

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

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 an investigational product within 4 weeks before the first treatment

4. Symptomatic central nervous system metastases

5. Other active malignancies (including other hematologic malignancies) or other
malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial

6. 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

7. Uncontrolled serious infection

8. Previous administration of vinorelbine

9. Patients with bad compliance

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Zhonghua Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

December 2011

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • metastatic triple-negative breast cancer
  • vinorebine
  • oxaliplatin
  • Breast Neoplasms