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

NCT04304352 | Unknown Phase 2

• 1 other identifier: IEO S582/111 RE324/2
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Study Arms (1)

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

Drug: Vinorelbine; Drug: Capecitabine; Drug: Cyclophosphamide

Interventions

Vinorelbine DRUG

Metronomic Vinorelbine 40 mg orally thrice a week

Also known as: Metronomic Vinorelbine

Metronomic VEX

Capecitabine DRUG

Metronomic Capecitabine 500 mg, thrice daily

Also known as: Metronomic Capecitabine

Metronomic VEX

Cyclophosphamide DRUG

Metronomic Cyclophosphamide 50 mg daily

Also known as: Metronomic Cyclophosphamide

Metronomic VEX

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Interventions

Vinorelbine; Capecitabine; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Marco Colleoni, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilia Montagna, MD

CONTACT

+390257489243; emilia.montagna@ieo.it

Claudia A Sangalli

CONTACT

+390257489840; claudia.sangalli@ieo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: July 29, 2011
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)