Breast CancerPhase 3NCT01758146
Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors
A Phase 3 study testing Tamoxifen and Letrozole in people with Breast Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase inhibitors in postmenopausal patients with early breast cancer in terms of: i) Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall survival Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen and Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- premenopausal patients,
- ER/PR negative
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Department of Radiotherapy, Post Graduate Institute of Medical Education & Research
Chandigarh, 91 160012
Budhi S Yadav, MD, 91 0172-275 ext. 6390, drbudhi@gmail.com
Dr Budhi S Yadav, MD
About this study
Official title: Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer
To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase inhibitors in postmenopausal patients with early breast cancer in terms of:
- Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall survival
Read the detailed description
The relationship between obesity and breast cancer is a complex one. Obesity is a risk factor for the development of breast cancer in postmenopausal women and has been linked to an increased risk of recurrence and decreased survival as compared to patients with normal weight.
The hypothesis that led to this study is that the amount of total-body aromatization capacity indicated by body mass index (BMI). In postmenopausal women and in premenopausal women with ovarian suppression, the major source of serum estrogens is the fat tissue, in which precursors are metabolized to estrogens by the enzyme aromatase. Thus, an increase in BMI leads to an increase in total-body aromatization and, consequently, an increase in oestrogen serum levels, which impact on breast cancer. Taken together, this suggests that BMI may serve as a useful surrogate parameter for total-body aromatization and eventually may be a practicable tool to tailor aromatase inhibitors (AIs) therapy for individual patients.
The study will include 360, postmenopausal patients with early breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor (PR). Patients will be randomly assigned to receive tamoxifen 20 mg once daily or AIs (letrozole 2.5mg/ anastrozole 1mg/exemestane 25mg) once daily for five years. Patients with a tumour stage IB, IC, or II irrespective of nodal stage (<10 positive nodes) will be included. Weight and height will be taken at baseline for calculation of BMI according to the WHO criteria. The frequency of adverse events will be used to assess safety throughout the study.
The primary end point will be disease-free survival (DFS). Secondary end points will be recurrence-free survival and overall survival (OS). The data will be analyzed for DFS and OS according to the BMI subgroups as well as two treatment arms (tamoxifen v AIs). The frequency of adverse events will be used to assess safety throughout the study.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, obesity, aromatase inhibitors, postmenopausal
- Medical subject headings
- Breast Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called Canditam, Nolvadex
20 mg once daily for 5 years
LetrozoleDrug
Also called 2.5 mg once daily for 5 years
Letroz, Femara, Letronat
| Study group | Role | What they receive |
|---|---|---|
| Arm A- Letrozole | Experimental | Aromatase inhibitor- letrozole 2.5mg once daily for 5 years Receives: Drug: Letrozole |
| Arm B- Tamoxifen | Active comparator | Tamoxifen 20 mg once daily for 5 years Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Event in the form of locoregional recurrence, distant metastasis, cancer in the contralateral breast, second primary cancer, or death from any cause.
Measured: From date of random assignment to the first event during 5 years
Secondary outcomes (2)
recurrence-free survival .
Disease specific mortality
Measured: From date of randomization until the date of first documented progression during 5 years
overall survival (OS)
Till death due to disease/ other cause over an average of 5 years
Measured: From day of diagnosis till date of death from disease/ other cause over an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2020
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Budhi Singh Yadav, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Dr Budhi S Yadav, MD, Principal investigator, Post Graduate Institute of Medical Education & Research, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758146
- Sponsor's protocol ID
- BMI
- Status last verified
- Mar 2020
- First submitted
- 1 Dec 2012
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors in Postmenopausal Patients With Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01758146
- Acronym / sponsor ID
- BMI
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, obesity, aromatase inhibitors, postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase inhibitors in postmenopausal patients with early breast cancer in terms of:
- Locoregional recurrence ii) Distant metastases iii) Disease-free survival iv) Overall survival
Detailed description
The relationship between obesity and breast cancer is a complex one. Obesity is a risk factor for the development of breast cancer in postmenopausal women and has been linked to an increased risk of recurrence and decreased survival as compared to patients with normal weight.
The hypothesis that led to this study is that the amount of total-body aromatization capacity indicated by body mass index (BMI). In postmenopausal women and in premenopausal women with ovarian suppression, the major source of serum estrogens is the fat tissue, in which precursors are metabolized to estrogens by the enzyme aromatase. Thus, an increase in BMI leads to an increase in total-body aromatization and, consequently, an increase in oestrogen serum levels, which impact on breast cancer. Taken together, this suggests that BMI may serve as a useful surrogate parameter for total-body aromatization and eventually may be a practicable tool to tailor aromatase inhibitors (AIs) therapy for individual patients.
The study will include 360, postmenopausal patients with early breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (ER) and/or progesterone receptor (PR). Patients will be randomly assigned to receive tamoxifen 20 mg once daily or AIs (letrozole 2.5mg/ anastrozole 1mg/exemestane 25mg) once daily for five years. Patients with a tumour stage IB, IC, or II irrespective of nodal stage (<10 positive nodes) will be included. Weight and height will be taken at baseline for calculation of BMI according to the WHO criteria. The frequency of adverse events will be used to assess safety throughout the study.
The primary end point will be disease-free survival (DFS). Secondary end points will be recurrence-free survival and overall survival (OS). The data will be analyzed for DFS and OS according to the BMI subgroups as well as two treatment arms (tamoxifen v AIs). The frequency of adverse events will be used to assess safety throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A- Letrozole | Experimental | Drug: LetrozoleAromatase inhibitor- letrozole 2.5mg once daily for 5 years |
| Arm B- Tamoxifen | Active comparator | Drug: TamoxifenTamoxifen 20 mg once daily for 5 years |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- premenopausal patients,
- ER/PR negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamoxifenAlso: Canditam, Nolvadex20 mg once daily for 5 years | Drug | Arm B- Tamoxifen |
| LetrozoleAlso: 2.5 mg once daily for 5 yearsLetroz, Femara, Letronat | Drug | Arm A- Letrozole |
Primary outcome
Disease free survival
Time frame: From date of random assignment to the first event during 5 years
Event in the form of locoregional recurrence, distant metastasis, cancer in the contralateral breast, second primary cancer, or death from any cause.
2 secondary outcomes
recurrence-free survival .
Time frame: From date of randomization until the date of first documented progression during 5 years
overall survival (OS)
Time frame: From day of diagnosis till date of death from disease/ other cause over an average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Budhi S Yadav, MD principal investigator
Post Graduate Institute of Medical Education & Research, Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamoxifen and Letrozole in people with Breast Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Budhi S Yadav, MD (919815981176, drbudhi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: From date of random assignment to the first event during 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.