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Metronomic Oral Chemotherapy With Cyclophosphamide, Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients

NCT04304352 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-06-28

No results posted yet for this study

Summary

This is a phase II study assessing the activity and safety of metronomic chemotherapy with cyclophosphamide and capecitabine and vinorelbine in advanced breast cancer patient in four different cohort of patients:

1. Untreated (naïve) patients with endocrine responsive disease
2. Pretreated patients with endocrine responsive disease
3. Untreated (naïve) patients with triple negative disease
4. Pretreated patients with triple negative disease The primary endpoint will be the progression-free survival

Conditions

Interventions

DRUG

Vinorelbine

Metronomic Vinorelbine 40 mg orally thrice a week

DRUG

Capecitabine

Metronomic Capecitabine 500 mg, thrice daily

DRUG

Cyclophosphamide

Metronomic Cyclophosphamide 50 mg daily

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Marco Colleoni, MD · European Institute of Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-29
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304352 on ClinicalTrials.gov