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

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ClinicalTrials.gov Identifier: NCT04304352
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

Brief 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

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: Vinorelbine Drug: Capecitabine Drug: Cyclophosphamide Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients
Actual Study Start Date : July 29, 2011
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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
Drug: Vinorelbine
Metronomic Vinorelbine 40 mg orally thrice a week
Other Name: Metronomic Vinorelbine

Drug: Capecitabine
Metronomic Capecitabine 500 mg, thrice daily
Other Name: Metronomic Capecitabine

Drug: Cyclophosphamide
Metronomic Cyclophosphamide 50 mg daily
Other Name: Metronomic Cyclophosphamide




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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
  5. 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).
  6. 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.
  7. Life expectancy greater than 6 months.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status performance status <2
  9. 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
  10. Geographically accessible for follow up.
  11. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Previous metronomic chemotherapy for advanced disease with capecitabine, cyclophosphamide and vinorelbine
  2. Patients defined as "refractory" to capecitabine, cyclophosphamide and vinorelbine (Progression Disease or Stable Disease < 6 months).
  3. Presence of symptomatic cerebral or leptomeningeal involvement.
  4. Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix.
  5. 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.
  6. 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
  7. Concurrent treatment with any other anti-cancer therapy except LHRH analogue.
  8. Patients with pre-existing motor or sensory peripheral neuropathy grade 2 according to NCI criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304352


Contacts
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Contact: Emilia Montagna, MD +390257489243 emilia.montagna@ieo.it
Contact: Claudia A Sangalli +390257489840 claudia.sangalli@ieo.it

Locations
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Italy
European Institute of Oncology Recruiting
Milan, Italy
Contact: Emilia Montagna, MD    +390257489 ext 243    emilia.montagna@ieo.it   
Sponsors and Collaborators
European Institute of Oncology
Investigators
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Principal Investigator: Marco Colleoni, MD European Institute of Oncology
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Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT04304352    
Other Study ID Numbers: IEO S582/111 RE324/2
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Capecitabine
Vinorelbine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators