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

Phase 1

• Conditions: ocally advanced or metastatic triple negative breast cancer (TNBC); MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001864-12-IT
• Lead Sponsor: IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 0

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., < 2 years after last menstruation) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the treatment period and for at least 6 months after the last dose of study drug;
9.Provision of a written informed consent signed prior to enrolment according to ICH/GCP.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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 cells x 109/L, platelet count < 100 cells x 109/L, or hemoglobin < 8 g/L;
b.serum total bilirubin >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 <50 mL/min calculated according to Cockcroft-Gault equation, and coagulation parameters international normalized ratio >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br> - the two treatment regimens in terms of clinical benefit (CB), overall survival (OS) and progression free survival (PFS). <br>- the tolerability and safety profile of each treatment regimen.<br><br>Predefined subgroup analyses by clinical characteristics to assess the internal consistency of the results.<br>