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

NCT03854617 | Unknown Phase 2 FDA Drug

• 1 other identifier: BC2
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Keywords

oral Navelbine; Metastasis Breast Cancer; metronomic chemotherapy

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (6)

• Time to Tumor Progression

  up to 36 months

• Time to Treatment Failure

  up to 36 months

• Progression free survival

  up to 36 months

• Overall survival

  up to 60 months

• Adverse events

  up to 36 months

Study Arms (2)

Oral NVB Metronomic

EXPERIMENTAL

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

Drug: Oral NVB Metronomic

Oral NVB Weekly

ACTIVE COMPARATOR

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.

Drug: Oral NVB Weekly

Interventions

Oral NVB Metronomic DRUG

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

Also known as: Oral Navelbine Metronomic

Oral NVB Metronomic

Oral NVB Weekly DRUG

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

Also known as: Oral Navelbine Weekly

Oral NVB Weekly

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Central Study Contacts

Binghe Xu, MD

CONTACT

86-10-87788826; xubinghe@medmail.com.cn

Fei Ma, MD

CONTACT

86-10-87788060; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 26, 2019
• Study Start: February 20, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2025
• Last Updated: February 26, 2019

Record last verified: 2019-02