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CompletedNCT02546934TNBCUpdated Apr 22, 2022

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

A Phase 3 interventional study of ABX, cisplatin and Gemcitabine, Cisplatin in Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-22.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
254
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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

Read the 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

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Conditions studied

  • Breast Cancer

Keywords

  • triple negative breast cancer
  • fine line chemotherapy
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 254 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
254 participants (estimated)

Study arms

  • Experimental
    ABX, cisplatin

    AP (ABX and cisplatin combination)

    Drug: ABX, cisplatin

  • Active comparator
    Gemcitabine, Cisplatin

    GP (Gemcitabine and Cisplatin combination)

    Drug: Gemcitabine, Cisplatin

Interventions

  • DrugABX, cisplatin

    ABX 125 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1

    Also known as: experimental arm

  • DrugGemcitabine, Cisplatin

    Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1

    Also known as: control arm

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What researchers measure

Primary outcomes

  1. PFS (Progression Free Survival)

    Time frame: 6 weeks

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 6 weeks

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 6 weeks

  3. Overall Survival (OS)

    Time frame: 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

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Study locations

1 site
  • Fudan University Cancer Hospital
    Shanghai, 200032, China
08

References and documents

Publications

  • Wang B, Sun T, Zhao Y, Wang S, Zhang J, Wang Z, Teng YE, Cai L, Yan M, Wang X, Jiang Z, Pan Y, Luo J, Shao Z, Wu J, Guo X, Hu X. A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022 Jul 12;13(1):4025. doi: 10.1038/s41467-022-31704-7. PubMed 35821019 ↗
  • Wang B, Zhao Y, Li Y, Xu Y, Chen Y, Jiang Q, Yao D, Zhang L, Hu X, Fu C, Zhang S, Chen S. A plasma SNORD33 signature predicts platinum benefit in metastatic triple-negative breast cancer patients. Mol Cancer. 2022 Jan 18;21(1):22. doi: 10.1186/s12943-022-01504-0. No abstract available. PubMed 35042534 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02546934
Lead sponsor
Fudan University
Responsible party
Xichun Hu (Dr, Fudan University) — Principal investigator
First posted
Sep 11, 2015
Start date
Mar 2016
Primary completion
Apr 2020
Completion
Apr 2020
Last update
Apr 22, 2022

Study contacts

Xichun Hu, MD, PhD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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