A Randomized Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy to Assess the Extent of Pulmonary Fibrosis and Disease Related Control and Survival in Breast Cancer Patients
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Development of Lung fibrosis
Study Overview
Brief Summary
Two hundred and sixty patients with breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. Arm 1 will receive Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be given followed by tamoxifen sequentially. The patients will be stratified for the following factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and b) central lung distance (CLD) > 2 cm.
Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum transforming growth factor (TGF) beta levels (baseline and at 6 months) and diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6 months).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with large operable lesions (pT/cT > 5 cm) or locally advanced breast cancers undergoing modified radical mastectomy or breast conservative surgery-(BCS) who need adjuvant post operative radiotherapy
- •Patients post mastectomy requiring radiotherapy because of nodal positivity
- •Completed planned chemotherapy schedule
- •ER and/or PR positive patients
- •Patients decided to be put on tamoxifen
- •Patients reliable for follow up
Exclusion Criteria
- •Patients with BCT who have pT1 or pT2 breast lesions (N0,N1)
- •Patients for palliative radiotherapy to the chest wall/breast/supraclavicular fossa
- •Any patient requiring radiation to the axillary or internal mammary area
- •Recurrent disease or metastatic disease
- •Patients on concurrent chemotherapy and radiation
Arms & Interventions
Concurrent Tamoxifen and Radiotherapy
ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.
Intervention: Tamoxifen (Drug)
Concurrent Tamoxifen and Radiotherapy
ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.
Intervention: Radiotherapy (Radiation)
Sequential radiotherapy and tamoxifen
ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.
Intervention: Tamoxifen (Drug)
Sequential radiotherapy and tamoxifen
ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Development of Lung fibrosis
Time Frame: Three years
Secondary Outcomes
- Locoregional failure and distant failure(Three years)
Investigators
Anusheel Munshi
Associate Professor
Tata Memorial Hospital