Impact of Obesity on the Efficacy of Endocrine Therapy With Aromatase Inhibitors

NCT01758146 | Unknown Phase 3 DMC

• 1 other identifier: BMI
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer

Keywords

Breast cancer; obesity; aromatase inhibitors; postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of random assignment to the first event during 5 years

Secondary Outcomes (2)

• recurrence-free survival .

  From date of randomization until the date of first documented progression during 5 years

• overall survival (OS)

  From day of diagnosis till date of death from disease/ other cause over an average of 5 years

Study Arms (2)

Arm A- Letrozole

EXPERIMENTAL

Aromatase inhibitor- letrozole 2.5mg once daily for 5 years

Drug: Letrozole

Arm B- Tamoxifen

ACTIVE COMPARATOR

Tamoxifen 20 mg once daily for 5 years

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

20 mg once daily for 5 years

Also known as: Canditam, Nolvadex

Arm B- Tamoxifen

Letrozole DRUG

Letroz, Femara, Letronat

Also known as: 2.5 mg once daily for 5 years

Arm A- Letrozole

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• premenopausal patients,
• ER/PR negative

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Department of Radiotherapy, Post Graduate Institute of Medical Education & Research

Chandigarh, 91 160012, India

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Tamoxifen; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr Budhi S Yadav, MD

  Post Graduate Institute of Medical Education & Research, Chandigarh, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Budhi S Yadav, MD

CONTACT

919815981176; drbudhi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: December 1, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

IN (1)