International clinical study investigating the role of two different chemotherapy regimens with drugs administered at low and continuous dosing in locally advanced or metastatic triple negative breast cancer patients (TNBC) as maintenance therapy after first line treatment. The VICTOR 3 study

An international, multicenter, phase II, randomized, parallel-arm trial investigating the role of two different metronomic chemotherapy regimens in locally advanced or metastatic triple negative breast cancer patients (TNBC) as maintenance therapy after first line treatment. The VICTOR 3 study - VICTOR 3

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001864-12-IT

Enrollment

180

Registered

2021-06-04

Start date

2017-04-06

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic triple negative breast cancer (TNBC) MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification cod

Interventions

Trade Name: NAVELBINE - 20 MG CAPSULE MOLLI 1 CAPSULA Product Name: Navelbine Pharmaceutical Form: Capsule, soft Trade Name: NAVELBINE - 30 MG CAPSULE MOLLI 1 CAPSULA Product Name: Navelbine Pharmace

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must meet all the following criteria to be eligible for study entry: 1. Female, aged = 18 years old; 2. Eastern Cooperative Oncology Group performance status (ECOG –PS) = 1; 3. Locally advanced or metastatic triple-negative breast cancer, i.e. HER2-negative status and ER and PgR negative status (as per local assessment); 4. Treatment with 1st line chemotherapy (with any drug excepted Bevacizumab-based regimens) as per clinical practice, and non-progressive when the treatment was terminated; 5. No more than 6 cycles of the previous chemotherapy; 6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1); 7. Willingness and ability to comply with the study protocol as judged by the Investigator; 8. For women who are not postmenopausal (i.e., =65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: 1. Previous treatment with vinorelbine or capecitabine; 2. 1st line therapy with a bevacizumab-based regimen; 3. Presence of brain metastases; 4. Any other investigational drug or any anti-cancer treatment (except for radiotherapy, if the treatment field does not include the liver); 5. Inadequate bone marrow, hepatic or renal function including the following: a. absolute neutrophils count of 1.5 × institution upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase >2.5 × ULN, or >5 × ULN for patients with liver metastases, alkaline phosphatase >2.5 × ULN, or >5 × ULN for patients with liver metastases, or >10 × ULN for patients with bone metastases; c. serum creatinine concentration >1.5 × ULN, creatinine clearance 1.5; 6. With the exception of basal cell carcinoma or cervical cancer in situ, history of another malignancy, unless in remission for 5 years or more and judged of negligible potential of relapse; 7. Known dihydropyrimidine dehydrogenase deficiency; 8. Treatment with sorivudine or its chemically related analogues, such as brivudine, within 4 weeks prior to randomization; 9. Evidence of any significant clinical disorder or concurrent illness or laboratory finding that, at the judgment of the Investigator, contra-indicate the inclusion of the patient in the study; 10. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures; 11. Unable to swallow tablets; 12. Previous significant surgical resection of stomach or small bowel 13. Patients requiring long-term oxygen therapy 14. Known hypersensitivity to any excipients of oral vinorelbine, oral capecitabine and to fluoropyrimidine.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the activity of the two study regimens (oral metronomic schedule of vinorelbine and combination of oral metronomic schedule of vinorelbine with fixed doses of capecitabine) in terms of proportion of patients alive and without disease progression after 12 weeks of maintenance therapy.;Primary end point(s): Proportion of patients alive and without progression after 12 weeks of maintenance therapy (PFS12w).;Timepoint(s) of evaluation of this end point: After 12 weeks of maintenance therapy (PFS12w).;Secondary Objective: To evaluate: - the two treatment regimens in terms of clinical benefit (CB), overall survival (OS) and progression free survival (PFS). - the tolerability and safety profile of each treatment regimen. Predefined subgroup analyses by clinical characteristics to assess the internal consistency of the results.	—

Measure

Time frame

Main Objective: To evaluate the activity of the two study regimens (oral metronomic schedule of vinorelbine and combination of oral metronomic schedule of vinorelbine with fixed doses of capecitabine) in terms of proportion of patients alive and without disease progression after 12 weeks of maintenance therapy.;Primary end point(s): Proportion of patients alive and without progression after 12 weeks of maintenance therapy (PFS12w).;Timepoint(s) of evaluation of this end point: After 12 weeks of maintenance therapy (PFS12w).;Secondary Objective: To evaluate: - the two treatment regimens in terms of clinical benefit (CB), overall survival (OS) and progression free survival (PFS). - the tolerability and safety profile of each treatment regimen. Predefined subgroup analyses by clinical characteristics to assess the internal consistency of the results.

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Secondary

Measure	Time frame
Secondary end point(s): PFS, calculated in each patient as the time from the date of treatment start to the date of first progression or death from any cause, whichever comes first. Subjects not having progressed or died by the end of the study will be censored at the last disease assessment date OS, calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. Clinical Benefit, defined as proportion of patients with CR+PR+SD and without grade 3-4 adverse events after 12 weeks of maintenance treatment. Maximum toxicity grade experienced by each patient for each specific toxicity; frequency of patients experiencing adverse events that are recorded as grade 3-5 (also grade 2 for neurotoxicity); adverse events will be graded according to NCI CTC AE, version 4.03. Type and frequency of serious adverse reactions.;Timepoint(s) of evaluation of this end point: PFS: at the date of first progression or death from any cause, whichever comes first. Subjects not having progressed or died by the end of the study will be censored at the last disease assessment date . OS: at the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. Clinical Benefit: after 12 weeks of maintenance treatment. Safety of the study treatments will be evaluated during the study, throughout the treatment period and including the follow-up period (30 days after the last dose of study treatment).	—

Measure

Time frame

Secondary end point(s): PFS, calculated in each patient as the time from the date of treatment start to the date of first progression or death from any cause, whichever comes first. Subjects not having progressed or died by the end of the study will be censored at the last disease assessment date OS, calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. Clinical Benefit, defined as proportion of patients with CR+PR+SD and without grade 3-4 adverse events after 12 weeks of maintenance treatment. Maximum toxicity grade experienced by each patient for each specific toxicity; frequency of patients experiencing adverse events that are recorded as grade 3-5 (also grade 2 for neurotoxicity); adverse events will be graded according to NCI CTC AE, version 4.03. Type and frequency of serious adverse reactions.;Timepoint(s) of evaluation of this end point: PFS: at the date of first progression or death from any cause, whichever comes first. Subjects not having progressed or died by the end of the study will be censored at the last disease assessment date . OS: at the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. Clinical Benefit: after 12 weeks of maintenance treatment. Safety of the study treatments will be evaluated during the study, throughout the treatment period and including the follow-up period (30 days after the last dose of study treatment).

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Countries

Italy, Portugal, Spain

Contacts

Public ContactLaboratorio Metodologia per la Rice

IRCCS-Istituto di Ricerche Farmacologiche Mario Negri

elena.copreni@marionegri.it0239014641

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026