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Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT03254654
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

Brief Summary:
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer

Condition or disease Intervention/treatment Phase
Advanced Triple-Negative Breast Cancer Drug: Vinorelbine Drug: Apatinib Phase 2

Detailed Description:
A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN trail)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN Trail)
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Vinorelbine Plus Apatinib

Vinorelbine: 20 mg/m2, D6, D13, D20

Apatinib: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.

Drug: Vinorelbine
Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15
Other Name: NVB

Drug: Apatinib
250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.

Active Comparator: Vinorelbine
Vinorelbine: 25 mg/m2, D1, D8, D15
Drug: Vinorelbine
Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15
Other Name: NVB




Primary Outcome Measures :
  1. PFS [ Time Frame: 6 weeks ]
    Progression Free Survival


Secondary Outcome Measures :
  1. 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 ]
    Overall Survival

  2. ORR [ Time Frame: 6 weeks ]
    Objective Response Rate

  3. Safety: Number of Participants with Adverse Events [ Time Frame: 6 weeks ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Performance Status 0-1
  2. Life expectancy longer than 3 months
  3. Histological proven unresectable recurrent or advanced breast cancer
  4. 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+)
  5. Patients must have progressed after 1 or 2 prior chemotherapy regimens for metastatic disease, and consistent with the following treatment failure definition: progress in the first-line or second-line regimen treatment, or follow-up disease progression less than 3 months after completion of their last dose
  6. At least one extracranial measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
  7. Radiation therapy within 4 weeks prior to enrollment
  8. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
  9. Be able to understand the study procedures and sign informed consent

Exclusion Criteria:

  1. Patients had prior treatment with vinorelbine
  2. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
  3. 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
  4. Treatment with an investigational product within 4 weeks before the first treatment
  5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
  6. Uncontrolled serious infection
  7. Unhealed wound or bone fracture
  8. Patients with hypertension and uncontrolled hypertension with hypotensive drugs therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg). Patients with grade I or above myocardial ischemia or myocardial infarction or arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency
  9. Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
  10. Coagulation disorders (PT > 16 s, APTT > 43 s, TT > 21 s, Fbg < 2g / L) Being treated with thrombolytic or anticoagulant therapy, with bleeding tendency or definite gastrointestinal bleeding concerns (eg: local active ulcer lesions, fecal occult blood + + or above)
  11. Artery or venous thrombosis occurred within 6 months before the study begins, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism, etc.
  12. Patient who has a history of psychotropic substance abuse and is unable to stop or have a history of mental disorders
  13. Have received prior treatment with a VEGFR TKI (Bevacizumab is permitted)
  14. Another malignancy within 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma

Information from the National Library of Medicine

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): NCT03254654


Contacts
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Contact: Xichun Hu, MD, PhD 64175590 ext 85006 xchu2009@hotmail.com
Contact: Jian Zhang, MD 64175590 ext 85000 syner2000@163.com

Locations
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China
Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD    64175590 ext 85006    xchu2009@hotmail.com   
Contact: Jian Zhang, MD    64175590 ext 85000    syner2000@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xichun Hu, MD, PhD Fudan University
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Responsible Party: Xichun Hu, Vice Director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier: NCT03254654    
Other Study ID Numbers: Fudan BR2017-23
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors