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

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT02546934
Collaborator
(none)
254
1
2
49
5.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: ABX, cisplatin
  • Drug: Gemcitabine, Cisplatin
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
254 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized Study of ABX Plus Cisplatin (AP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABX, cisplatin

AP (ABX and cisplatin combination)

Drug: ABX, cisplatin
ABX 125 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
Other Names:
  • experimental arm
  • Active Comparator: Gemcitabine, Cisplatin

    GP (Gemcitabine and Cisplatin combination)

    Drug: Gemcitabine, Cisplatin
    Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
    Other Names:
  • control arm
  • Outcome Measures

    Primary Outcome Measures

    1. PFS (Progression Free Survival) [6 weeks]

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [6 weeks]

    2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [6 weeks]

    3. Overall Survival (OS) [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Females with age between 18 and 70 years old

    2. Histological proven unresectable recurrent or advanced breast cancer, including de novo stage IV disease.

    3. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.

    4. No prior chemotherapy for metastatic breast cancer is permitted. Prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.

    5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)

    6. Performance status no more than 1

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

    8. Life expectancy longer than 12 weeks

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

    10. Be able to understand the study procedures and sign informed consent.

    Exclusion Criteria:
    1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)

    2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process 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 previous radiotherapy

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

    5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed 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. Patients 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

    Locations

    Site City State Country Postal Code
    1 Fudan University Cancer Hospital Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Xichun Hu, MD, PhD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xichun Hu, Dr, Fudan University
    ClinicalTrials.gov Identifier:
    NCT02546934
    Other Study ID Numbers:
    • Fudan BR2015-18 CBCSG018
    First Posted:
    Sep 11, 2015
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Xichun Hu, Dr, Fudan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2022