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

Breast Cancer Clinical Trial

— CONSET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00896155
• Other study ID #: 349
• Status: Recruiting
• Phase: Phase 3
• First received: May 8, 2009
• Last updated: August 27, 2011
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: August 2011
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Data Safety and Monitoring Committee, Tata Memorial Hospital India
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Tamoxifen
260 patients of 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 20 Mg once daily given concurrently with radiotherapy while in ARM-2 radiotherapy followed by tamoxifen 20 mg once daily sequentially.

Radiation:
• Radiotherapy
260 patients of 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 20 Mg once daily given concurrently with radiotherapy while in ARM-2 radiotherapy followed by tamoxifen 20 mg once daily sequentially.

Locations

Country	Name	City	State
India	Tata Memorial Center	Parel	Mumbai

Sponsors (2)

Lead Sponsor	Collaborator
Tata Memorial Hospital	Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Lung fibrosis		Three years	No
Secondary	Locoregional failure and distant failure		Three years	No