|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01758146 |
|
Date of registration:
|
01/12/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
|
|
Scientific title:
|
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer |
|
Date of first enrolment:
|
January 2012 |
|
Target sample size:
|
412 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT01758146 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Budhi S Yadav, MD |
|
Address:
|
|
|
Telephone:
|
91 0172-275 |
|
Email:
|
drbudhi@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Budhi S Yadav, MD |
|
Address:
|
|
|
Telephone:
|
919815981176 |
|
Email:
|
drbudhi@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Dr Budhi S Yadav, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Post Graduate Institute of Medical Education & Research, Chandigarh, India |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- postmenopausal patients with breast cancer who have hormones receptor positive tumour
as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor
(PR).
- patients with a tumour stage IB, IC, or II irrespective of nodal stage (< 10 positive
nodes)
Exclusion Criteria:
- premenopausal patients,
- ER/PR negative
Age minimum:
45 Years
Age maximum:
80 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Cancer
|
|
Intervention(s)
|
|
Drug: Letrozole
|
|
Drug: Tamoxifen
|
|
Primary Outcome(s)
|
|
Disease free survival
[Time Frame: From date of random assignment to the first event during 5 years]
|
|
Secondary Outcome(s)
|
|
overall survival (OS)
[Time Frame: From day of diagnosis till date of death from disease/ other cause over an average of 5 years]
|
|
recurrence-free survival .
[Time Frame: From date of randomization until the date of first documented progression during 5 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|