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

NCT ID: NCT03254654

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-16
• Study Completion Date: 2021-08-01

Brief Summary

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

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)

Conditions

Advanced Triple-Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

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

Apatinib

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Vinorelbine

Intervention Type: DRUG

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

Interventions

Vinorelbine

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

NVB

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xichun Hu

Vice Director of department of medical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xichun Hu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, , China

Countries

China

Other Identifiers

Fudan BR2017-23

Identifier Type: -

Identifier Source: org_study_id