Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Paclitaxel in Triple Negative Breast Cancer (TNBC) (TNBC)
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ClinicalTrials.gov Identifier: NCT01287624 |
Recruitment Status :
Completed
First Posted : February 1, 2011
Last Update Posted : March 23, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Gemcitabine,cisplatin Drug: Gemcitabine, Paclitaxel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
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 |
- PFS (Progression Free Survival) [ Time Frame: 6 weeks ]
- Objective Response Rate (ORR) [ Time Frame: 6 weeks ]
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287624
China, Shanghai | |
Fudan University Cancer Hospital | |
Shanghai, Shanghai, China, 200032 |
Principal Investigator: | Xichun Hu, MD,PhD | Fudan University |
Responsible Party: | Xichun Hu, Dr, Fudan University |
ClinicalTrials.gov Identifier: | NCT01287624 |
Other Study ID Numbers: |
Fudan BR2010-04 CBCSG 006 ( Other Identifier: Chinese Breast Cancer Study Group ) |
First Posted: | February 1, 2011 Key Record Dates |
Last Update Posted: | March 23, 2015 |
Last Verified: | March 2015 |
triple negative breast cancer fine line chemotherapy |
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Gemcitabine |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |