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Breast CancerPhase 2NCT02768415

Study of Apatinib Combined With Oral Vinorelbine in Metastatic HER2 Negative Breast Cancer

A Phase 2 study testing Apatinib and Oral Vinorelbine in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral vinorelbine can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Apatinib and Oral Vinorelbine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Jun 2016to Jan 2018
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 year-old women; HER2 negative(immunohistochemistry or fluorescence in situ hybridization);
  • ECOG score: 0-1, expected survival time ≥ 3months;
  • Pathologically or cytologically confirmed breast cancer;
  • Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-2 standard chemotherapies after recurrence and metastasis;
  • According to RECIST 1.1, exist at least ≥1 measurable lesion(CT >1cm，other examination >2cm) ;
  • The patients have enough organ function. The laboratory test indexes must comply with the following requirements:
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  • Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value when liver metastasis Renal function: serum creatinine ≤ 1.0times the upper limit of normal value, creatinine clearance >50ml/min（Cockcroft-Gault formula)
  • Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration；
  • Can swallow oral drugs;
  • The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.

Who cannot join

  • The patients in pregnancy or lactation growth period and did not take effective contraception;
  • The patients who received ≥3 chemotherapies（Do not include endocrine therapy）after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study;
  • The patients with a variety of factors that affect the oral administration and absorption of drugs；
  • The patients previously received anti-VEFG of anti-VEGFR therapies；
  • The patients with rapid progression of viscera invasion(liver lesion >1/2 viscera area or liver dysfunction);
  • The patients have uncontrollable mental illness.
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  • The patients who had serious adverse effect to oral vinorelbine or were allergic to vinorelbine.
  • The patients who have only bone metastasis without other measurable lesion;
  • The patients experience severe cardiovascular diseases;
  • The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.
  • Abnormal bone marrow functions(neutrophil<1.5G/L, platelet count <75G/L, hemoglobin <90g/L)；
  • Abnormal renal function(serum creatinine > 1.5 times the upper limit of normal value)；
  • Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);
  • The patients have uncontrollable brain metastasis;
  • The patients do not have good compliance to the therapy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Phase II Study of Apatinib Combined With Oral Vinorelbine in Pretreated Metastatic HER2 Negative Breast Cancer

The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral vinorelbine can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.

Read the detailed description

Apatinib is an orally administered second-generation blocker of the phosphorylation of the tyrosine residues within the intracellular domain of VEGF receptor 2 (VEGFR2). A prospective, open label, phase II multicenter trial of apatinib in heavily pretreated patients with metastatic triple-negative breast cancer demonstrated that the daily dose of apatinib 500 mg/day is active in pretreated metastatic TNBC with encouraging rates of disease stabilization and PFS.

Vinorelbine is a highly active drug in the treatment of MBC, both as a single agent or in combination regimens, and is well tolerated, with a low incidence of severe toxicity. Clinical trials demonstrated oral NVB provided comparable effectiveness to iv NVB. and oral availability allows using different schedules.

The NCCN guideline introduces that combination chemotherapy is one of the standard treatment options in metastatic breast cancer, especially in patients with visceral metastases and/or need of rapid symptom or disease control.

Theoretically, anti-angiogenesis regimen combined with chemotherapy may present increasing therapeutic effect. Related researches are urgently needed to find optimal combined therapy.

The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral vinorelbine can shrink or slow the growth of pretreated HER2 negative breast cancer. The safety of the combination will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if this combination is safe and effective in pretreated HER2 negative metastatic breast cancer patients.

Conditions
Breast Cancer
Being tested
Apatinib, Oral Vinorelbine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02768415
Study groupRoleWhat they receive
lapatinib+oral vinorelbineExperimentalapatinib 425/500mg qd, 21days/cycle oral vinorelbine 60mg/m2 d1, 8, 15 21days/cycle*3cycles, after 3 cycles: 80mg/m2 d1, 8, 15 21days/cycle
Receives: Drug: Apatinib; Drug: Oral Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

    Measured: up to 1 year after the last patient enrolled

Secondary outcomes (5)

  1. remission rate (RR) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

    Measured: up to 1 year after the last patient enrolled

  2. overall survival (OS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

    Measured: up to 1 year after the last patient enrolled

  3. overall response rate (ORR) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine

    Measured: up to 1 year after the last patient enrolled

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: up to 1 year after the last patient enrolled

  5. Potential biomarkers to predict efficacy, drug resistance and side effects of anti-angiogenic therapy plus chemotherapy in advanced breast cancer.

    Measured: up to 1 year after the last patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJan 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02768415
Sponsor's protocol ID
CH-BC-046
Status last verified
Jun 2019
First submitted
4 May 2016
Last updated
19 Jun 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and Oral Vinorelbine in people with Breast Cancer, run by Chinese Academy of Medical Sciences 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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Jun 2019. 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?

Results are not available in the source record.

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?

Progression free survival (PFS) among metastatic HER2 negative breast cancer treated with apatinib and oral vinorelbine (time frame: up to 1 year after the last patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768415.

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 19 Jun 2019.

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