Advanced, triple receptor negative breast cancer MedDRA version: 14.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ciclofosfamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent disease must not be amenable to resection or radiation therapy with curative intent. • Documentation of Estrogen and Progestin Receptor (ER and PgR) negative status (immunohistochemistry 0%) and HER2/neu receptor negative status (i.e., FISH negative or immunohistochemistry 0 or +1). • Prior treatment with an anthracycline and/or a taxanes in the neoadjuvant, adjuvant or metastatic disease setting. • Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not considered target lesions unless increase in size has been observed following completion of radiation therapy. • Female, 18 years of age or older. • ECOG performance status 0, 1 or 2. • Resolution of all acute toxic effects of prior therapy or surgical procedures to grade = 1 (except alopecia). • The definitions of minimum adequacy for organ function required prior to study entry Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Major surgery, radiation therapy, or systemic therapy within 3 weeks of study enrollment except palliative radiotherapy to non-target metastatic lesions. • Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomenigeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic. • Diagnosis of any second malignancy within the last 3 years, except for contralateral breast cancer also with triple negative receptor status, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervic. • Any of the following within the 2 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, cerebrovascular accident including transient attack, or pulmonary embolus not correlated to the breast cancer. • Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2 or atrial fibrillation of any grade. • Current treatment with therapeutic doses of coumarin or oral anti-vitamin K agents such as warfarin and phenprocoumon derivates. Low molecular weight heparin is allowed at any dose level. • Known human immunodeficiency virus infection. • Female who is pregnant or nursing; female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the trial and for 3 months after the last dose of study treatment. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization. Female patients must be surgically sterile or be in postmenopausal, or must agree to use effective contraception during the period of therapy and for 3 months after the last dose of study treatment. • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which in the judgment of the investigator, would make the patient inappropriate for entry into this study. • Acute kidney injury or failure within 3 months prior to starting study treatment. • Current treatment with drug-related nephrotoxic effects. • Ongoing condition described as 'urethral' (or 'dysuria/frequency') syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Objective response rate (ORR), defined as the percentage of all patients who experienced a Complete Response (CR) or Partial Response (PR).;Timepoint(s) of evaluation of this end point: 24 months;Main Objective: To evaluate objective response rate (ORR), defined as the percentage of all patients who experienced a Complete Response (CR) or Partial Response (PR) of the combination cisplatin and metronomic cyclophosphamide in patients with previously treated, triple receptor negative (ER/PR and HER2/neu), locally recurrent or metastatic breast cancer.;Secondary Objective: To evaluate Time to Tumor Progression (TTP) of the combination cisplatin and metronomic cyclophosphamide in this patient population - To assess the safety of the combination cisplatin and metronomic cyclophosphamide - To examine the Health-Related Quality of Life (HRQoL) of the combination cisplatin and metronomic Cyclophosphamide | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): time to progression;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed