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

NCT03254654 | Completed Phase 2

• 1 other identifier: Fudan BR2017-23
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  6 weeks

Secondary Outcomes (3)

• 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

• ORR

  6 weeks

• Safety: Number of Participants with Adverse Events

  6 weeks

Study Arms (2)

Vinorelbine Plus Apatinib

EXPERIMENTAL

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; Drug: Apatinib

Vinorelbine

ACTIVE COMPARATOR

Vinorelbine: 25 mg/m2, D1, D8, D15

Drug: Vinorelbine

Interventions

Vinorelbine DRUG

Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15

Also known as: NVB

Vinorelbine; Vinorelbine Plus Apatinib

Apatinib DRUG

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.

Vinorelbine Plus Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance Status 0-1
• Life expectancy longer than 3 months
• 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 (ER \<1%, PR \<1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+)
• 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
• At least one extracranial measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
• Radiation therapy within 4 weeks prior to enrollment
• All patients enrolled are required to have adequate hematologic, hepatic, and renal function
• Be able to understand the study procedures and sign informed consent

You may not qualify if:

• Patients had prior treatment with vinorelbine
• Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
• 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
• Treatment with an investigational product within 4 weeks before the first treatment
• Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
• Uncontrolled serious infection
• Unhealed wound or bone fracture
• 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
• Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
• 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)
• 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.
• Patient who has a history of psychotropic substance abuse and is unable to stop or have a history of mental disorders
• Have received prior treatment with a VEGFR TKI (Bevacizumab is permitted)
• Another malignancy within 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

MeSH Terms

Interventions

Vinorelbine; apatinib

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of department of medical oncology

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 18, 2017
• Study Start: August 16, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)