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CTRI Number  CTRI/2018/06/014620 [Registered on: 26/06/2018] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Single Arm Study 
Public Title of Study   Safety and effectiveness study of ormeloxifene in breast cancer patients. 
Scientific Title of Study   A multicentric open label phase II safety and efficacy study of ormeloxifene in tamoxifen resistant metastatic/recurrent breast cancer patients. 
Trial Acronym  - 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ECTS/16/002, Ver 02, 08 Nov 2017, Amendment 001, 12 Oct 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudeep Gupta 
Designation  Principal Investigator/Overall Trial Coordinator 
Affiliation  Tata Memorial Center 
Address  Room No. 1109, 11th Floor, Homi Bhabha Block,Tata Memorial Hospital, Tata Memorial Centre,Dr. Ernest Borges Marg, Parel (East)
-
Ahmadabad
GUJARAT
400012
India 
Phone  9821298642  
Fax  -  
Email  sudeepgupta04@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  Titanium city center, Block "G" 410-412. Nr. Sachin Tower, 100 Ft. Road, Satellite, Ahmedabad-380 015, India.
-
Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax  -  
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  Titanium city center, Block "G" 410-412. Nr. Sachin Tower, 100 Ft. Road, Satellite, Ahmedabad-380 015, India.
-
Dohad
GUJARAT
380015
India 
Phone  9825585119  
Fax  -  
Email  milansatia@ethicare-cro.com  
 
Source of Monetary or Material Support  
HLL Lifecare Limited, (A Government of India Enterprises) Corporate R & D Centre, Akkulum, Sreekariyam, P.O Thiruvananthapuram-695017, Kerala, India  
 
Primary Sponsor  
Name  HLL Lifecare Limited 
Address  Corporate R & D Centre Akkulam, Sreekariyam P.O., Thiruvananthapuram- 695 017 Kerala (State), India 
Type of Sponsor  Other [A Government of India Enterprises] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kishore Singh  Maulana Azad Medical College  Department of Radiotherapy, Bahadur Shah Zafar Marg,
North
DELHI 		 011-23238423

drkishoresingh@gmail.com 
Dr Rakesh Kapoor  Postgraduate Institute of Medical Education and Research   Department of Radiotherapy, Ground floor, Nehru Hospital, Sector-12, Chandigarh-160012
Chandigarh
CHANDIGARH 		 91-172-2756396
91-172-2744401
drkapoor.r@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospitals and Critical Care (P) Ltd.  A/407, Sahid Nagar, Department of Medical Oncology, Room No 2, Ground Floor, Bhubaneswar, 751007
Khordha
ORISSA 		 916742540183
916742545860
info@sparshhospitals.com 
Dr Sudeep Gupta  Tata Memorial Center  3rd Floor, Main Building,Dr. Ernest Borges Marg, Parel (East)
Mumbai
MAHARASHTRA 		 9821298642
22-24177201
sudeepgupta04@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee MAMC  Approved 
Institutional Ethics Committee of Postgraduate Institute of Medical Education and Research  Approved 
Institutional Ethics Committee of Sparsh Hospital and Critical Care (P) ltd.  Approved 
Institutional Ethics Committee of Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, Tamoxifen resistant metastatic/recurrent breast cancer ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ormeloxifene 120 mg per day  Ormeloxifene 120 mg per day in tamoxifen resistant metastatic/recurrent breast cancer patients. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•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).  60±2 Days, 120±2 Days 
 
Secondary Outcome  
Outcome  TimePoints 
(1) Clinical Benefit Rate (CBR)
(2) Disease control rates
(3) Safety analyses
 		 30 ± 2 days, 60 ± 2 days, 120 ± 2 days, 180 ± 2 days, 270 ± 2 days, 360 ± 2 days 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/07/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  		 Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a phase II study to check efficacy and safety of 120 mg  oral dose of ormeloxifene in tamoxifen resistant metastatic breast cancer patients. Primary objective of the study is to evaluate clinical response rates at 16 weeks after start of treatment with 120 mg oral dose of ormeloxifene. Secondary objectives are to evaluate investigator assessed progression free survival, to evaluate clinical benefit of ormeloxifene and to study the effect of ormeloxifene on quality of life. The study will be conducted in two stages. In stage I total 23 subjects and in stage II 33 subjects will be enrolled who are falling under inclusion criteria as determined in the protocol.  In stage I patients will undergo screening visit at day -7 to 0, enrolment visit at day 1, improvement visit at 60+/-2 days and end of visit at 120+/- 2 days. In stage II patients will undergo visit 0 (Day -7 to 0): screening visit, visit 1 (Day 1): Enrolment visit , visit 2 (day 30+/-2 days): Improvement visit, visit 3 (day 60+/- 2 days): Improvement visit, visit 4 (Day 120+/- 2 days): Improvement visit, visit 5 (Day 180+/-2 days): Improvement visit, visit 7 (day 360+/-2 days): Improvement visit. Assessment of parameters like radiographic tumour assessments, Laboratory assessment, health related quality of life and safety assessment will be done at visits as mentioned in the protocol. 


 
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