Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: null- Tamoxifen resistant metastatic/recurrent breast cancer
Conditions
Interventions
Intervention1: Ormeloxifene 120 mg per day: Ormeloxifene 120 mg per day in tamoxifen resistant metastatic/recurrent breast cancer patients.
Sponsors
HLL Lifecare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ability to provide written informed consent for participation in the study. 2.Female patients with = 18 years, Who are either premenopausal as confirmed by no irregularities in last three consecutive menstrual periods OR serum estrogen (E2) level that is the premenopausal range. OR Who were premenopausal at the time of diagnosis of breast cancer but who have undergone bilateral oophorectomy and/or radiotherapy ovarian ablation and/or gonadotropin releasing hormone agonist treatment, as part of treatment for breast cancer. 3.Histologically or cytologically confirmed breast cancer from most recent historical reports of histopathology. 4.Immunohistochemistry (IHC) evidence of estrogen receptor positive (allred score of >3/8) and IHC or FISH evidence of negative cerb B2 status. 5.IHC or FISH evidence for negative Cerb B2 status •In case of historical reports of IHC confirming evidence of ER-positive and Cerb B2 negative status, a repeat IHC is not required. 6.Patients whose cancer has evidence of tamoxifen resistance as suggested by at least one of the following: i)Development of recurrence of and/or metastasis while patient on adjuvant tamoxifen ii)Development of recurrence of and/or metastasis within one year of completing adjuvant tamoxifen. iii)Progression of metastatic/recurrent disease while patient was on tamoxifen or progression of metastatic/recurrent disease within 6 months of stopping tamoxifen. 7.Stage I: Patient treated with not more than 2 chemotherapy regimens, including (neo) adjuvant chemo regimens. Stage II: Patient treated with not more than 4 chemotherapy regimens, including (neo) adjuvant chemo regimens. 8.Patients should have at least one measurable lesion as defined by RECIST criteria (version 1.1). 9.Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10.Patients with normal liver, kidney and marrow function, resolution of all toxic effects of prior therapy or surgical procedures, as per the investigator’s clinical judgement. 11.Life expectancy of at least 6 months in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: 1.Patients with extensive advanced, symptomatic visceral disease that requires chemotherapy. 2.Patients with known uncontrolled or symptomatic CNS metastases. 3.Patients with major surgery or any anti-cancer therapy within 2 weeks prior to enrolment. 4.History of prior invasive malignancy, except breast cancer or non-melanoma skin cancer. 5.Women of childbearing potential without adequate contraception. •Unwilling to use at least one reliable method of contraception (e.g., a barrier method [condom or occlusive cap] with spermicidal foam/gel/film/cream/suppository, a non-hormone releasing intrauterine device or intrauterine system, sterilisation of sole male partner, abstinence) throughout the study period and for 6 months after the last study drug treatment. •Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy during the study is not allowed. 6.Women who are pregnant or breast feeding. 7.Women in their post-menopausal state - a period of continuous absence of menstrual cycles for 12 months or more as calculated at the time of screening 8.Any history of cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not limited to: active cardiac disease - angina pectoris that requires the use of anti-anginal medication; recent history of unstable angina or myocardial infarction within last 6 months, ventricular arrhythmias except for benign premature ventricular contractions; supra ventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic congestive heart failure or pericarditis; history of cardiac disease - myocardial infarction documented by elevated cardiac enzymes, or a cardiac troponin or cardiac myoglobin or persistent regional wall abnormalities on assessment of left ventricular function; New York Heart Association (NYHA) class III or IV congestive heart failure; and/or documented cardiomyopathy. 9.Acute or active chronic infections which, in the opinion of the Investigator, may affect patient safety or participation in the study. 10.Known history of alcohol/drug abuse. 11.Known history of allergy to any of the study treatments. 12.History of stem cell or bone marrow transplantation. 13.Active use of potent CYP3A4 inhibitors or inducers (e.g. carbamazepine, dexamethasone and ethosuximide; cimetidine, amiodarone, azithromycin etc.). 14.Participation in any other clinical study or administration of any other investigational medications within 30 days of enrolment or 5 half- lives, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Overall response rates (ORR) will be calculated as the proportion of patients who achieved a tumor response of partial response (PR) or complete response (CR) as per RECIST 1.1 guidelines. Data will be as number of patients (% of patients) who achieved a tumor response of partial response (PR) or complete response (CR).Timepoint: 60±2 Days, 120±2 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Clinical Benefit Rate (CBR) (2) Disease control rates (3) Safety analyses Timepoint: 30 ± 2 days, 60 ± 2 days, 120 ± 2 days, 180 ± 2 days, 270 ± 2 days, 360 ± 2 days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed