Advanced Breast CancerPhase 2VEXNCT04304352
Metronomic Oral Chemotherapy With Cyclophosphamide, Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients
A Phase 2 study testing Vinorelbine, Capecitabine and Cyclophosphamide in people with Advanced Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Vinorelbine, Capecitabine and Cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2011to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre- or post-menopausal women (age ≥18 years) with histologically or cytologically (cell block) proven, locally advanced (inoperable) or metastatic breast carcinoma. Immunohistochemical evaluation of estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor (EGFR) according to European Institute of Oncology guidelines is mandatory.
- Patients with HER2 overexpressed tumors, are eligible if they had received previous trastuzumab therapy for advanced disease, and/or a treatment with anti HER2 targeted therapy.
- Patients fulfilling one of the following criteria:
- Patients with measurable disease as per RECIST 1.1 criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT scan
- Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST 1.1 criteria. Bone lesions must be evaluable by plain CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible.
- Patients may have received any primary and/or adjuvant therapies, as any previous lines of chemotherapy and endocrine therapy for advanced disease. Patients may have received metronomic capecitabine, methotrexate and cyclophosphamide in adjuvant setting at least 12 months before study entry
Show all 21Show fewer
- Previous treatment with capecitabine, cyclophosphamide and vinorelbine not in metronomic schedule for advanced disease is allowed, provided that the patient has progressive disease at study entry and the patients should not be defined as "refractory" to treatments (Pathological Response or Complete Response or Stable Disease > 6 months).
- Patients may have had previous hormonal therapy as treatment of metastatic disease provided that the patient has progressive disease at study entry. Hormonal therapy must be discontinued prior to study entry, excluding Luteinizing Hormone-Releasing Hormone (LHRH) analogue.
- Life expectancy greater than 6 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status performance status <2
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥ 3,000/μL
- absolute neutrophil count ≥ 1,000/μL
- platelets ≥ 100,000/μL
- Haemoglobin ≥ 10 g/dl
- total bilirubin within normal institutional limits
- Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) ≤ 2 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance ≥ 60 mL/min/1.73 m for patients with creatinine levels above institutional normal
- Geographically accessible for follow up.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Previous metronomic chemotherapy for advanced disease with capecitabine, cyclophosphamide and vinorelbine
- Patients defined as "refractory" to capecitabine, cyclophosphamide and vinorelbine (Progression Disease or Stable Disease < 6 months).
- Presence of symptomatic cerebral or leptomeningeal involvement.
- Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Malabsorption syndrome or disease affecting significantly gastrointestinal function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine
- Concurrent treatment with any other anti-cancer therapy except LHRH analogue.
- Patients with pre-existing motor or sensory peripheral neuropathy grade 2 according to NCI criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Emilia Montagna, MD, +390257489 ext. 243, emilia.montagna@ieo.it
About this study
Official title: A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients
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:
- Untreated (naïve) patients with endocrine responsive disease
- Pretreated patients with endocrine responsive disease
- Untreated (naïve) patients with triple negative disease
- Pretreated patients with triple negative disease The primary endpoint will be the progression-free survival
Read the 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:
- Untreated (naïve) patients with endocrine responsive disease
- Pretreated patients with endocrine responsive disease
- Untreated (naïve) patients with triple negative disease
- 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
- Advanced Breast Cancer
- Being tested
- Vinorelbine, Capecitabine, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Metronomic Vinorelbine
Metronomic Vinorelbine 40 mg orally thrice a week
CapecitabineDrug
Also called Metronomic Capecitabine
Metronomic Capecitabine 500 mg, thrice daily
CyclophosphamideDrug
Also called Metronomic Cyclophosphamide
Metronomic Cyclophosphamide 50 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Metronomic VEX | Experimental | 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 Receives: Drug: Vinorelbine; Drug: Capecitabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
the time between the first study dose administration and the date of progression of the disease or cancer-related death, whichever occurs first
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start29 Jul 2011
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Colleoni, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304352
- Sponsor's protocol ID
- IEO S582/111 RE324/2
- Acronym
- VEX
- Status last verified
- Jun 2023
- First submitted
- 9 Mar 2020
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04304352
- Acronym / sponsor ID
- VEX / IEO S582/111 RE324/2
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 29 Jul 2011 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Untreated (naïve) patients with endocrine responsive disease
- Pretreated patients with endocrine responsive disease
- Untreated (naïve) patients with triple negative disease
- 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:
- Untreated (naïve) patients with endocrine responsive disease
- Pretreated patients with endocrine responsive disease
- Untreated (naïve) patients with triple negative disease
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metronomic VEX | Experimental | Drug: Vinorelbine, Drug: Capecitabine, Drug: CyclophosphamideMetronomic 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Pre- or post-menopausal women (age ≥18 years) with histologically or cytologically (cell block) proven, locally advanced (inoperable) or metastatic breast carcinoma. Immunohistochemical evaluation of estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor (EGFR) according to European Institute of Oncology guidelines is mandatory.
- Patients with HER2 overexpressed tumors, are eligible if they had received previous trastuzumab therapy for advanced disease, and/or a treatment with anti HER2 targeted therapy.
- Patients fulfilling one of the following criteria:
- Patients may have received any primary and/or adjuvant therapies, as any previous lines of chemotherapy and endocrine therapy for advanced disease. Patients may have received metronomic capecitabine, methotrexate and cyclophosphamide in adjuvant setting at least 12 months before study entry
- Previous treatment with capecitabine, cyclophosphamide and vinorelbine not in metronomic schedule for advanced disease is allowed, provided that the patient has progressive disease at study entry and the patients should not be defined as "refractory" to treatments (Pathological Response or Complete Response or Stable Disease > 6 months).
Key exclusion criteria (8 listed)
- Previous metronomic chemotherapy for advanced disease with capecitabine, cyclophosphamide and vinorelbine
- Patients defined as "refractory" to capecitabine, cyclophosphamide and vinorelbine (Progression Disease or Stable Disease < 6 months).
- Presence of symptomatic cerebral or leptomeningeal involvement.
- Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinorelbineAlso: Metronomic VinorelbineMetronomic Vinorelbine 40 mg orally thrice a week | Drug | Metronomic VEX |
| CapecitabineAlso: Metronomic CapecitabineMetronomic Capecitabine 500 mg, thrice daily | Drug | Metronomic VEX |
| CyclophosphamideAlso: Metronomic CyclophosphamideMetronomic Cyclophosphamide 50 mg daily | Drug | Metronomic VEX |
Primary outcome
Time to progression (TTP)
Time frame: 28 days
the time between the first study dose administration and the date of progression of the disease or cancer-related death, whichever occurs first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Colleoni, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine, Capecitabine and Cyclophosphamide in people with Advanced Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilia Montagna, MD (+390257489243, emilia.montagna@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (TTP) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.