Trials / Unknown
UnknownNCT04304352
Metronomic Oral Chemotherapy With Cyclophosphamide, Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients
A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- Sponsor
- European Institute of Oncology · Academic / Other
- Sex
- Female
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This is an institutional, monocentric, open-label, phase II study of oral "metronomic" Vinorelbine plus Capecitabine and Cyclophosphamide (VEX) in patients with advanced breast cancer . Patients will receive the combination regimen as follow: Cyclophosphamide 50 mg daily Capecitabine 500 mg, thrice daily Vinorelbine 40 mg orally thrice a week Four independent cohorts of patients will be evaluated in the study: 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 Combination will be administered until disease progression or unacceptable toxicity. The primary endpoint will be to assess the Time to progression (TTP) of VEX combination in the four different cohorts
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2011-07-29
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2020-03-11
- Last updated
- 2023-06-28
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04304352. Inclusion in this directory is not an endorsement.