Health Condition 1: null- Women with metastatic triple negative breast cancer
Conditions
Interventions
Intervention1: cyclophosphamide and methotrexate: cyclophosphamide (50 mg, orally)will be given on Day 1 and day 28 of each cycle and methotrexate (12 mg/m2, orally) will be given on Day 1, 8, 15 and
Sponsors
Jehangir Clinical Development centre Pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females above 18 years and 2.Patients who are being prescribed (by their treating oncologists) metronomic therapy within 6 weeks of completion of 1st/2nd line chemotherapy for TNBC. 3. Women with triple negative phenotype [Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) negative invasive breast cancer confirmed on IHC] with metastatic disease (based on chest, abdominal, bone imaging performed within 3 months prior to screening). [Note: HER2 negative by FISH or HER2 0 or 1+ by IHC]. 4. Unidimensionally measurable disease according to RECIST 1.1. 5. Pre-treated with not more than 1 regimen in metastatic setting. 6. Peripheral WBC count >= 3,000 mm3, absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3 based on previous reports within 15 days from screening. 7. Normal myocardial left ventricular function > 50% based on previous reports within 6 months from screening. 8. Must have an adequate renal function (serum creatinine 9. Must be in good general health (Eastern Cooperative Oncology Group (ECOG)) performance 10. Life expectancy > 6 months. 11. Must be willing to or likely to comply with all study requirements. 12. Must be able and willing to provide written informed consent. 13. Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use acceptable method of contraception during the study.
Exclusion criteria
Exclusion criteria: 1.If a subject has a biopsy done at the time of metastasis, showing a receptor change. 2.Inflammatory breast cancer (T4d). 3.Active brain metastasis. (If the subject has brain metastasis which is treated and stable, s/he is eligible). 4.Another active cancer present. 5.Known contraindications to receive cyclophosphamide or methotrexate or any medical condition where the subject may be unable to swallow. 6.Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin. 7.Pregnant or breast-feeding women. 8.Known HIV infection. 9.Currently participating or had participated in other interventional study for last 3 months prior to screening. 10.Any other clinically significant medical condition e.g. active infections, cardiac, psychiatric, neurological, pulmonary or immunological conditions etc. which may, in the judgment of the investigator, interfere with the subjectâ??s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine progression free survival (PFS) in women with metastatic TNBC treated with maintenance metronomic chemotherapy after 1st or 2nd line chemotherapy. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢To determine overall survival (OS) â?¢Determination of biologic correlation between markers of angiogenesis and molecular prognostic markers with tumor recurrence (clinical outcome) in women with metastatic TNBC treated with metronomic chemotherapy. â?¢To determine the safety and toxicity of MMCT in these patients and its effect on regimen compliance. â?¢To determine the impact of MMCT on quality of life of these patients. Timepoint: At 18 months | — |
Countries
India
Contacts
Public ContactDr Shona Nag
Jehangir Clinical Development Centre Pvt Ltd
Outcome results
None listed