Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Paclitaxel in Triple Negative Breast Cancer (TNBC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
307 Hospital of PLA
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sun Yat-sen University
Tianjin Medical University Cancer Institute and Hospital
Zhejiang Cancer Hospital
Changhai Hospital
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01287624
First received: January 31, 2011
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Drug: Gemcitabine,cisplatin
Drug: Gemcitabine, Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • PFS (Progression Free Survival) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: January 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine,cisplatin
GP (gemcitabine and cisplatin)
Drug: Gemcitabine,cisplatin
Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
Other Name: experimental arm
Active Comparator: Gemcitabine, Paclitaxel
GT (gemcitabine and paclitaxel combination)
Drug: Gemcitabine, Paclitaxel
Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Paclitaxel 175 mg/m2, IV, 3h,D1
Other Name: control arm

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287624

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
307 Hospital of PLA
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sun Yat-sen University
Tianjin Medical University Cancer Institute and Hospital
Zhejiang Cancer Hospital
Changhai Hospital
Investigators
Principal Investigator: Xichun Hu, MD,PhD Fudan University
  More Information

No publications provided

Responsible Party: Xichun Hu, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT01287624     History of Changes
Other Study ID Numbers: Fudan BR2010-04, CBCSG 006
Study First Received: January 31, 2011
Last Updated: December 1, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
triple negative breast cancer
fine line chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 01, 2014