| CTRI Number |
CTRI/2011/06/001805 [Registered on: 13/06/2011] Trial Registered Prospectively |
| Last Modified On: |
06/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study how efficacious and safe Letrozole is in breast cancer patients |
|
Scientific Title of Study
|
A Multi-Centre, Prospective, Open Label Study on Safety and Efficacy of Letrozole as Adjuvant Treatment of Post-menopausal Women with Hormone Receptor Positive Early Breast Cancer |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CP/13/10 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Antaryami Maharana |
| Designation |
Medical Monitor |
| Affiliation |
Sristek Consulting Pvt. Ltd |
| Address |
DLF, Cyber City, Block No. 3, 8th Floor, Gachibowli, Hyderabad, Andhra Pradesh.
Hyderabad
ANDHRA PRADESH
500019
India |
| Phone |
09985312894 |
| Fax |
04066129566 |
| Email |
antaryami.maharana@sristek.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rahul Namjoshi |
| Designation |
Project Manager |
| Affiliation |
Project Manager |
| Address |
Cipla Ltd.;3rd Floor, Raj Plaza, LBS Marg, Vikhroli West, Mumbai 400083
NIL
Mumbai (Suburban)
MAHARASHTRA
400083
India |
| Phone |
09820978403 |
| Fax |
02225787855 |
| Email |
rahul.namjoshi@cipla.com |
|
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Source of Monetary or Material Support
|
| Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai - 400008 |
|
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Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Bellasis Road, Mumbai Central, Mumbai, Phone: (022) 23082891 Fax: (022)25787855. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naga Kishore |
Balaji Cancer Care Centre |
Balaji Cancer Care Centre, Gowrishanker Theatre Road, Kothapet, Guntur 522001, Andhra Pradesh.
Guntur
ANDHRA PRADESH |
09849085861
08632320114
kishore_maddula@hotmail.com |
| Dr Chetan Deshmukh |
Deenanath Mangeshkar Hospital & Research Centre |
Erandwane, Near Mhatre Bridge, Pune-411004
Pune
MAHARASHTRA |
09850811449
02040151968
drchetandeshmukh@gmail.com |
| Dr Chandra Sekhar Tamane |
Seth Nandlal Dhoot Hospital |
Medical Oncologist,Seth Nandlal Dhoot Hospital, A1, MIDC, Chikalthana, Jalna Road,415570
Aurangabad
MAHARASHTRA |
09225316906
0240-2485831
chandratamane@yahoo.com |
| Dr Rajender Singh Arora |
Sujan Surgical Cancer Hospital |
consultant Medical oncologist,
52/B, Shankar Nagar, Main Road, Amravati - 444606, Maharashtra ,India
Amravati
MAHARASHTRA |
91-9881260388
91-721-2578568
dr_rsarora@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Amravati Ethics Committee for Sujan Surgical Cancer Hospital |
Approved |
| Clinicom Independent Ethics Committee for Balaji Cancer Care Centre |
Approved |
| Clinicom Independent Ethics Committee for Seth Nandlal Dhoot Hospital |
Approved |
| Institutional Ethics Committee for Deenanath Mangeshkar Hospital & Research Centre |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Women with Hormone Receptor Positive Early Breast Cancer, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Letrozole Tablet |
2.5 mg oral tablets once daily for 12 weeks |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Female |
| Details |
Note: There is no upper age limit for this study.
1. Subjects or Legally Acceptable Representative (LAR) willing to sign informed consent.
2. Post menopausal women with non-metastatic breast cancer whose tumors are estrogen-and/or progesterone-receptor positive (ER and/or PgR positive) and have undergone breast cancer surgery with negative surgical margins.
3. Women of age greater than or equal to 45 years.
4. Postmenopausal state was defined by the following conditions, at least one of
• Serum follicle stimulating hormone (FSH) greater than or equal to 30 mIU/mL and amenorrhea greater than or equal to 1 year.
• Bilateral oophorectomy
(OR)
• Women without menses for the last 5 years.
5. Adequate bone marrow function as shown by
• White Blood Cells (WBC) greater than or equal to 3.5 x 109/L
• Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 109/L
• Platelets greater than or equal to 100,000/ml
• Hemoglobin (Hb) greater than or equal to 9 g/dL
6. Adequate hepatic function as shown by
• Aspartate Aminotransferase (AST) 7–35 U/L
• Alanine Aminotransferase (ALT) 7–31 U/L
• Gamma Glutamyl Transferase (GGT) 5–36 U/L
7. Cholesterol levels 3.6–5.2 mmol/L
8. Subjects who have undergone surgery of breast cancer and received chemotherapy and/or radiotherapy (subjects should be considered for screening who have completed a minimum of 4weeks after receiving chemotherapy and/or radiotherapy).
9. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 |
|
| ExclusionCriteria |
| Details |
1. Multifocal/Multicentric disease (cancer that starts in several different sites).
2. Subjects with bilateral breast tumours.
3. Subjects with in-situ lesions in the contra-lateral breast.
4. Evidence of inflammatory breast cancer or distant metastasis.
5. Any adjuvant therapy within 4 weeks of screening.
6. Had previous or concomitant other (non-breast cancer) malignant disease within the past 5 years, apart from adequately treated basal or squamous-cell carcinoma of the skin or in-situ carcinoma of the cervix.
7. Subjects who were given any investigational drugs within the past 30 days.
8. Subjects treated with any other drugs known to influence plasma estrogen levels.
9. Subject with a drug induced menopausal status [e.g., Luteinizing-Hormone-Releasing Hormone (LHRH) treatment].
10. Subjects who have a history of any of the following conditions within 6 months prior to study enrolment:
• Clinically significant myocardial infarction or severe/unstable angina pectoris.
• New York Heart Association (NYHA) class III or IV congestive heart failure.
• Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism - clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease or asthma).
11. Subjects who had breast cancer chemoprevention with anti-estrogens.
12. Subjects on hormone replacement therapy/adjuvant therapy unless stopped at least 4 weeks before screening visit except for estradiol vaginal tablets, estradiol vaginal ring, and estrogen cream.
13. Known history of hypersensitivity reactions to letrozole or to one of the excipients.
14. Subjects with Child-Pugh grade C, serum creatinine greater than 2xUNL.
15. Subjects with gastrectomy, small bowel resection, malabsorption syndrome, and dysphagia. |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in serum estradiol levels from baseline. |
From baseline (Day0) to Visit 3 (Day21), Visit 4 (Day42), Visit 5 (Day84) and Visit 6 (Day98) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 4. Assessment of safety will be performed according to the National Cancer Institute’s common terminology criteria for adverse events (NCICTCAE) (version 4.0). |
During study period of 14 weeks |
| 3. Clinically significant vital examination, lab investigations, or X-ray findings. |
During study period of 14 weeks |
| 2. Incidence of drug related adverse events. |
From baseline (Day0) to Visit 3 (Day21), Visit 4 (Day42), Visit 5 (Day84) and Visit 6 (Day98) |
| 1. Incidence of adverse events. |
From baseline (Day0) to Visit 3 (Day21), Visit 4 (Day42), Visit 5 (Day84) and Visit 6 (Day98) |
|
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Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
20/06/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
Not published in any journal |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This study is a Phase-IV, multi centre, prospective, open label study to evaluate safety and efficacy of Letrozole in women with hormone receptor positive early breast cancer patients. The primary objective of the study is to determine mean change in serum estradiol levels from baseline to 14 weeks. Total 35 subjects will be enrolled from 3 centers of India. |