Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients

Phase 3

• Conditions: Pulmonary Fibrosis; Breast Cancer
• Interventions: Drug: Tamoxifen; Radiation: Radiotherapy

• Registration Number: NCT00896155
• Lead Sponsor: Tata Memorial Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-11
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-27
• Last Update Posted: 2011-08-30
• Primary Completion: 2011-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent Tamoxifen and Radiotherapy	Radiotherapy	ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.
Sequential radiotherapy and tamoxifen	Radiotherapy	ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.
Concurrent Tamoxifen and Radiotherapy	Tamoxifen	ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.
Sequential radiotherapy and tamoxifen	Tamoxifen	ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.

Primary Outcome Measures

Name	Time	Method
Development of Lung fibrosis	Three years

Secondary Outcome Measures

Name	Time	Method
Locoregional failure and distant failure	Three years

Trial Locations

Locations (1)

Tata Memorial Center; 🇮🇳 Parel, Mumbai, India