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Human Epidermal Growth Factor 2 Negative Carcinoma of BreastPhase 2NCT03854617

A Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer

A Phase 2 study testing Oral NVB Metronomic and Oral NVB Weekly in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Chinese Academy of Medical Sciences.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a randomized, open-label, parallel, multi-center study, aims to evaluate the efficacy and safety of metronomic chemotherapy with oral Navelbine versus intermittent oral Navelbine in female patients with HER2 negative Metastasis Breast Cancer. Read more about this study

Who is it for?
Ages 18 to 85 years, women only
What is being tested?
Oral NVB Metronomic and Oral NVB Weekly
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
No sites listed yet
Study dates
20 Feb 2019to 20 Dec 2025
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 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients with life expectancy ≥ 3 months, age ≥ 18 years at the time informed consent is signed.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 as assessed within 21 days prior to randomization (Appendix ).
  • Subjects with HER2 negative metastasis breast cancer, source documented, defined as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines (Appendix ).
  • Subjects with measurable metastatic disease defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines (Appendix ) .
  • Subjects may previously exposed to anthracyclines (e.g. doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel) including:
  • Subject has been pretreated in the adjuvant or neoadjuvant setting with anthracyclines and/or taxanes before breast cancer relapsing;
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  • Subjects has experienced treatment failure while receiving or after completing anthracycline- and/or taxane- based chemotherapy;
  • Subjects who are not suitable for the choice of anthracycline- and/or taxane- based chemotherapy as first-line treatment in the judgment of investigator.
  • Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. An interval of less than 4 weeks after radiotherapy was not allowed.Concurrent limited field radiation therapy (RT) is allowed. At least one measurable lesion must be completely outside the radiation portal in accordance with RECIST 1.1 guidelines;
  • At least 30 days from major surgery before randomization, with full recovery;
  • Adequate bone marrow function as evidenced by the following:
  • Absolute Neutrophil Count (ANC) ≥ 1500/mm2;
  • Platelets ≥ 100,000/mm2;
  • Hemoglobin (Hb) ≥ 10 g/dL.
  • Adequate liver function as evidenced by the following:
  • Total serum bilirubin ≤ 1.5 times upper limit of normal range (ULN);
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times ULN (if hepatic metastases present ≤ 5.0 times ULN);
  • Alkaline phosphatase < 5 x ULN.
  • Adequate renal function as evidenced by the following:
  • -Creatinine clearance > 40 mL/min (by Cockcroft-Gault).
  • Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of randomization and agree to take an adequate contraceptive measure.
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
  • Able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • History of, or current active cancer other than breast cancer, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
  • Patients with medical conditions that the only manifestation is hydrothorax, ascites, bone lesions or other un-measurable diseases.
  • Subjects with visceral crisis in the judgment of investigator. Visceral crisis is defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies, and rapid progression of disease. Visceral crisis is not the mere presence of disease of visceral metastases, but implies important visceral compromise leading to a clinical indication for a more rapidly efficacious therapy, particularly since chemotherapy option at progression will probably not be possible.
  • Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of Oral NVB.
  • Subjects with dysphagia, or inability to swallow the tablets.
  • Subjects with symptoms suggesting central nervous system (CNS) involvement or leptomeningeal metastases, any suspicious sins or symptoms of CNS involvement or leptomeningeal metastases should be excluded by CT or MRI scans.
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  • Other serious illness or medical conditions by the investigator during screening:
  • Clinically significant cardiac disease;
  • Unstable diabetes;
  • Uncontrolled hypercalcemia;
  • Clinically significant active infections (current or in the last two weeks).
  • Previous organ allograft.
  • Current peripheral neuropathy ≥grade 2 according to NCI version 4.0 criteria.
  • More than one previous line of chemotherapy in advanced setting.
  • Concomitant hormonal therapy for MBC.
  • Ongoing anti-coagulation therapy.
  • Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator.
  • Patients with psychiatric disorder or other disease leading to incompliance to the therapy.
  • Known hypersensitivity to any ingredient of the study drug.
  • An interval of less than 3 weeks between the last dose of previous chemotherapy and randomization.
  • Previous treated by oral NVB.
  • Treatment with any investigational drug within 30 days before the beginning of treatment with study drug. Less than 30 days since receipt of any other investigational product or device.

Trial locations and contacts

No sites are listed yet.

Binghe Xu, MD contact

86-10-87788826 ext. 86-10-87715711

xubinghe@medmail.com.cn

Fei Ma, MD contact

86-10-87788060 ext. 86-10-87715711

drmafei@126.com

About this study

Official title: A Randomized, Open-label, Parallel Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer

This is a randomized, open-label, parallel, multi-center study, aims to evaluate the efficacy and safety of metronomic chemotherapy with oral Navelbine versus intermittent oral Navelbine in female patients with HER2 negative Metastasis Breast Cancer.

Read the detailed description
  1. The significant efficacy and good safety profile of Vinorelbine in the treatment of advanced breast cancer are accepted.
  2. Oral NVB presents absolute bioavailability of 40% and oral availability allows to use different schedules and the endothelial cell functionality and motility are interfered at very low drug concentration
  3. Oral NVB at 50 mg three times a week (Monday-Wednesday-Friday) has been tested in phase Ia/Ib/II trials, highlighting the excellent safety of this scheme combined with an interesting activity in various European countries.
  4. The study aims to evaluate the efficacy and safety of metronomic chemotherapy with oral Navelbine versus intermittent oral Navelbine in female patients with HER2 negative Metastasis Breast Cancer.
Being tested
Oral NVB Metronomic, Oral NVB Weekly
Keywords
oral Navelbine, Metastasis Breast Cancer, metronomic chemotherapy

What participants receive

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

  • Oral NVB MetronomicDrug

    Also called Oral Navelbine Metronomic

    50mg three times weekly on Mondays (or Tuesdays), Wednesdays (or Thursdays) and Friday (or Saturdays). A cycle is a 3 weeks period.

  • Oral NVB WeeklyDrug

    Also called Oral Navelbine Weekly

    60mg/m2 weekly for cycle 1 and 80mg/m2 weekly for subsequent cycles in the absence of grade 3 or 4 toxicity. A cycle is a 3 weeks period

Study groups in NCT03854617
Study groupRoleWhat they receive
Oral NVB MetronomicExperimental50mg three times weekly on Mondays (or Tuesdays), Wednesdays (or Thursdays) and Friday (or Saturdays). A cycle is a 3 weeks period.
Receives: Drug: Oral NVB Metronomic
Oral NVB WeeklyActive comparator60mg/m2 weekly for cycle 1 and 80mg/m2 weekly for subsequent cycles in the absence of grade 3 or 4 toxicity. A cycle is a 3 weeks period.
Receives: Drug: Oral NVB Weekly

What is being measured

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

  1. Disease Control Rate

    Disease Control Rate (DCR) is the proportion of subjects who have best overall response of CR + PR + SD with duration of ≥6 weeks.

    Measured: 12 weeks

Secondary outcomes (6)

  1. Time to Tumor Progression

    Time to Tumor Progression (TTP) is defined as the time from randomization to time of progressive disease.

    Measured: up to 36 months

  2. Time to Treatment Failure

    Time to Treatment Failure (TTF) is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient toxicity, patient preference, or death.

    Measured: up to 36 months

  3. Progression free survival

    Progression free survival (PFS) is the time from the date of randomization to the date of first documentation of disease progression, or to the date of death from any case, whichever occurs first.

    Measured: up to 36 months

  4. Overall survival

    Overall survival (OS) will be measured from the date of randomization until the date of death from any case.

    Measured: up to 60 months

  5. Adverse events

    Adverse events including Serious AEs and non-serious AEs (since ICF signed and until 30 days after last intake of study medication)

    Measured: up to 36 months

  6. Quality of Life (QoL)

    The FACT-B +4 (Version 4) (Appendix ) QoL questionnaires will be filled in at baseline before randomization, then every 6 weeks during the Randomization Treatment Period and at EoTV. Changes of the scores from baseline of the parameters will be provided from baseline.

    Measured: up to 36 months

Timeline

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

  1. First posted26 Feb 2019
  2. Study start20 Feb 2019 (estimated)
  3. Primary completion20 Dec 2021 (estimated)
  4. Study completion20 Dec 2025 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03854617
Sponsor's protocol ID
BC2
Status last verified
Feb 2019
First submitted
19 Feb 2019
Last updated
26 Feb 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral NVB Metronomic and Oral NVB Weekly in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Chinese Academy of Medical Sciences.

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 23 inclusion and 22 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Binghe Xu, MD (86-10-87788826 ext. 86-10-87715711, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (time frame: 12 weeks). 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 NCT03854617.

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 26 Feb 2019.

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