| CTRI Number |
CTRI/2011/05/001733 [Registered on: 13/05/2011] Trial Registered Retrospectively |
| 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 Anastrozole is in women with breast cancer |
|
Scientific Title of Study
|
A Phase IV, Single Arm, Open label, Multi-Centric Study to Evaluate Efficacy, Safety and Tolerability of Anastrozole as an adjuvant to Paclitaxel for Postmenopausal Women with hormone-receptor positive metastatic Breast Cancer . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/16/10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanveer Maksud |
| Designation |
Medical Oncologist |
| Affiliation |
Medical Oncologist |
| Address |
Medical Oncologist, Oncology Department,Bharat Cancer Hospital and Research Institute,Opp HP Petrol Pump, Surat Bardoli Road, Saroli,
Surat395010,Gujarat, India
NIL
Surat
GUJARAT
395010
India |
| Phone |
02612641000 |
| Fax |
02612641004 |
| Email |
tanveermaksud@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Nitin Joshi |
| Designation |
Associate Director Medical Affairs & Safety |
| Affiliation |
Associate Director Medical Affairs & Safety |
| Address |
Karmic Lifesciences,
802, Building No. 3, Raheja Mind Space(SEZ), Plot No. 3, TTC Industrial Area, Airoli, Navi Mumbai
NIL
Thane
MAHARASHTRA
400708
India |
| Phone |
02261170410 |
| Fax |
02261170499 |
| Email |
nitin.joshi@karmiclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanveer Maksud |
| Designation |
Principal Investigator |
| Affiliation |
Principal Investigator |
| Address |
Bharat Cancer Hospital and Research Institute,
Opp HP Petrol Pump, Surat Bardoli Road, Saroli,
Surat 395010,Gujarat, India
NIL
Surat
GUJARAT
395010
India |
| Phone |
02612641000 |
| Fax |
02612641004 |
| Email |
tanveermaksud@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787855 |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Bellasis Road, Mumbai Central, Mumbai, Phone: (022) 23082891 Fax: (022)25787855. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanveer Maksud |
Bharat Cancer Hospital and Research Institute, |
Medical Oncologist, Oncology Department, Opp. HP Petrol Pump,
Surat Bardoli Road,
Saroli, Surat 395010,
Gujarat, India
Surat
GUJARAT |
02612641000
0261-2641004
tanveermaksud@yahoo.com |
| Dr Ajay Mehta |
Central India Cancer Research Institute |
Director, Department of Surgical Oncology, 11Shankar Nagar,
West High Court Road, Nagpur440010
Nagpur
MAHARASHTRA |
07122520956
-
ajayonco@hotmail.com |
| Dr Minakshi Yeola |
Datta Meghe Institute of Medical Sciences |
Department of Surgery,
Datta Meghe Institute of Medical Sciences,
Acharya Vinoba Bhave Rural Hospital
Sawangi (Meghe)
wardha – 442004
Wardha
MAHARASHTRA |
09822189896
drmeenu7@rediffmail.com |
| Dr K M Kamble |
Govt. Medical College |
Professor & Head Radiation Therapy, Govt. Medical College,Medical Square,Nagpur 440003
Nagpur
MAHARASHTRA |
09850246275
917122745209
drkmkamble@yahoo.co.in |
| Dr A K Akhtar |
NKP Salve Lata Mangeshkar Hospital & Research Institute |
Head, Department of
Surgery, Digdoh Hills ,
Hingna Road, Nagpur 440019
Nagpur
MAHARASHTRA |
09823148808
murtazaakhtar@indiatimes.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Central India Cancer Research Institute Ethics Committee |
Approved |
| ETHIC (Ethical Trial Of Health In Community) Committee for Bharat Cancer Hospital and Research Institute |
Approved |
| Institutional Ethics Committee for Datta Meghe Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee of Govt. Medical College, Nagpur |
Approved |
| Institutional Ethics Committee of NKP Salve Lata Mangeshkar Hospital & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Postmenopausal Women with hormone-receptor positive metastatic Breast Cancer., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anastrozole 1 mg Tablet |
Anastrozole 1 mg tablet once daily for duration of 126 days along with fluids and Paclitaxel 175mg/ m2 will be given as an adjuvant therapy over 3 hours every 21st day for six cycles. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Note: This trial do not have upper age limit for inclusion criteria.
1.A potential subject willing to give written informed consent on his own or legally acceptable representative (LAR) /Impartial witness in case of Illiterate subject and comply with all study procedures.
2.Female subjects entering the study should be greater than or equal to 45 Years of age.
3.Subjects entering the study should be Post-menopausal women, defined as:
a.Bilateral Surgical Oophorectomy or Amenorrhea greater than or equal to 5 years
b.Age greater than or equal to 45 years and Amenorrhea greater than or equal to 1 year
c.Chemotherapy induced Amenorrhea greater than or equal to 2 years
d.Radiotherapy induced Amenorrhea at least 3 months before.
4.Subjects participating in the study should be those with histologically or cytologically proven pathological diagnosis of Metastatic Breast Cancer
5.Subjects should have been proven Estrogen Receptor and/or Progesterone Receptor Positive (ER+/PR+).
6.Subjects entering the study should have a radiologically measurable disease
7.Subjects who have received adjuvant Tamoxifen are eligible, if progression has been established within 24 months since treatment start.
8.Subjects receiving Paclitaxel as first line of chemotherapy for advanced Metastatic Breast Cancer or Treatment-naive patients.
9.Subjects who have received previous treatment with targeted therapy are eligible, whereas subjects already receiving Anastrozole or other aromatase inhibitors should undergo a one month washout period prior to the start of study drug administration.
10.Subjects entering the study should have following Normal Hematological values (Hb greater than 9.0 gm/ dL, Platelet greater than or equal to 1, 00000/ cumm), Hepatic Profile (Bilurubin, Total Biluribin less than or equal to 1.5 times ULN, Alalnine Transaminase (ALT)less than or equal to 2.5 time ULN, Aspartate Transaminase (AST) less than or equal to 2.5 times ULN, Alkaline Phosphatase (ALP) less than 2.5 ULN,)) and Renal Functions (Serum Creatinine less than or equal to 1.5 times ULN).
11.Subjects entering the study should have an ECOG Performance Status of 0-2.
12.Subjects participating in the study should have a life expectancy of at least 6 months, or as per the investigators discretion.
|
|
| ExclusionCriteria |
| Details |
Note: This trial do not have upper age limit for exclusion criteria.
1. Subjects who are pre-menopausal women.
2.Subjects who have received previous hormone treatment with class of aromatase inhibitor or any other hormonal treatment within 1 month in metastatic disease.
3.Subjects who are negative for Estrogen Receptor and/or Progesterone Receptor (Negative ER- / PR status).
4.Subjects receiving Glucocorticoid therapy
5.Subjects with an increase in High Density Lipoprotein-Cholesterol (HDL-C).
6.Subjects with known Inflammatory breast cancer, refractory malignancy or metastasis in the central nervous system
7.Subjects with only bone metastasis.
8.Subjects with a non-measurable disease.
9.Subjects with known hypersensitivity to the study drug or to any of the excipients.
10.Subjects with secondary malignancy except for basal skin carcinoma or adequately treated cervical in-situ carcinoma
11.Subjects who have participated in any other investigational drug therapy within 1 month prior to the screening visit.
12.Subjects with any other severe concurrent disease, which in the judgment of the investigator would make the subject inappropriate for entry into this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage reduction in the Serum Estradiol levels as compared to baseline in Hormone-receptor Positive Metastatic Breast Cancer patients |
At Visit-2 (Day 21) and Visit-7 (Day 126) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects who achieve complete or partial response and assessed for overall response as per RECIST Version 1.1 using imaging studies (CT/ MRI) |
At Visit 4 (Day 63) and Visit 7 (Day 126). |
| Percentage of subjects who achieve Time to progression (TTP) as per RECIST Version 1.1 using imaging studies (CT/ MRI) |
At Visit 4 (Day 63) and Visit 7 (Day 126). |
| Percentage of subjects who achieve Progression Free Survival (PFS) as per RECIST Version 1.1 using imaging studies (CT/ MRI) |
At Visit 4 (Day 63) and Visit 7 (Day 126). |
| Safety of the study drug will be estimated from type, number, frequency and percentage of subjects with AE(s) |
During study period. |
| Treatment Emergent Adverse Events (TEAE defined as an AE which is definitely or probably related to study medication) as per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02. |
During study period. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2011 |
| 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="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published in any journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a single arm, open label, multi-centric study to evaluate efficacy, safety and tolerability of Anastrozole as an adjuvant to Paclitaxel for postmenopausal women with hormone-receptor positive metastatic breast cancer. In this study 30 subjects will be enrolled from 4 participating centers in India.The primary objective of study is to measure and compare the effects of Anastrozole in the reduction of serum estradiol levels in metastatic breast cancer patients. Study will be conducted in 2 phases: Screening Phase (Screening Visit) and Enrollment & Treatment Phase (Visit 1 – Visit 7). The study duration is of 32 weeks including 2 weeks of screening, 12 weeks of enrolment period, and 18 weeks of treatment period. |