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

Sponsor
European Institute of Oncology
Study ID
NCT04304352
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Metronomic Vinorelbine 40 mg orally thrice a week
  • Capecitabine — DRUG
    Metronomic Capecitabine 500 mg, thrice daily
  • Cyclophosphamide — DRUG
    Metronomic Cyclophosphamide 50 mg daily

Study Details

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

Key Dates

Start date
Jul 29, 2011
Status verified
Jun 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
162 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Metronomic VEX
    Metronomic VEX (Oral Cyclophosphamide 50 mg daily continuous, Oral Capecitabine 500 mg, thrice daily continuous, Oral Vinorelbine 40 mg day 1,3 and 5 every week

Primary Outcome Measure

Time to progression (TTP) [ Time Frame: 28 days ]

Central Contacts

Related Studies