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. VICTOR-3 study

Phase 1

• Conditions: ocally advanced or metastatic triple negative breast cancer (TNBC); MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative 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); MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001864-12-ES
• Lead Sponsor: IRCCS - Istituto di Ricerche Farmacologiche Mario Negri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-22
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

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

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