Advanced Triple-Negative Breast CancerPhase 2NCT03254654
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
A Phase 2 study testing Vinorelbine and Apatinib in people with Advanced Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Advanced Triple-Negative Breast Cancer
- What is being tested?
- Vinorelbine and Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2017to 1 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
Read the 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
- Being tested
- Vinorelbine, Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called NVB
Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15
ApatinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vinorelbine; Drug: Apatinib |
| Vinorelbine | Active comparator | Vinorelbine: 25 mg/m2, D1, D8, D15 Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: 6 weeks
Secondary outcomes (3)
OS
Overall Survival
Measured: 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
Objective Response Rate
Measured: 6 weeks
Safety: Number of Participants with Adverse Events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start16 Aug 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254654
- Sponsor's protocol ID
- Fudan BR2017-23
- Status last verified
- Apr 2022
- First submitted
- 17 Aug 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03254654
- Acronym / sponsor ID
- Fudan BR2017-23
- Conditions
- Advanced Triple-Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vinorelbine Plus Apatinib | Experimental | Drug: Vinorelbine, Drug: ApatinibVinorelbine: 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. |
| Vinorelbine | Active comparator | Drug: VinorelbineVinorelbine: 25 mg/m2, D1, D8, D15 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinorelbineAlso: NVBExperimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15 | Drug | Vinorelbine, Vinorelbine Plus Apatinib |
| Apatinib250 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 Plus Apatinib |
Primary outcome
PFS
Time frame: 6 weeks
Progression Free Survival
3 secondary outcomes
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
ORR
Time frame: 6 weeks
Safety: Number of Participants with Adverse Events
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Related trials for Advanced Triple-Negative Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Hu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine and Apatinib in people with Advanced Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.