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

• Sponsor: Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03254654
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 47.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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)

Study Design

• Study Type: Interventional
• Actual 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: Aug 16, 2017
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

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 Names: 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 Names: NVB

Outcome Measures

Primary Outcome Measures

1. PFS [6 weeks]

   Progression Free Survival

Secondary Outcome Measures

1. 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]

   Overall Survival

2. ORR [6 weeks]

   Objective Response Rate

3. Safety: Number of Participants with Adverse Events [6 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

1. 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.

2. Patient who has a history of psychotropic substance abuse and is unable to stop or have a history of mental disorders

3. Have received prior treatment with a VEGFR TKI (Bevacizumab is permitted)

4. Another malignancy within 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma

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, Vice Director of department of medical oncology, Fudan University
• ClinicalTrials.gov Identifier: NCT03254654
• Other Study ID Numbers: Fudan BR2017-23
• First Posted: Aug 18, 2017
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms; Apatinib; Vinorelbine

Study Results

No Results Posted as of Apr 20, 2022