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

NCT ID: NCT00896155

Last Updated: 2011-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-12-31

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).

Conditions

Pulmonary Fibrosis; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concurrent Tamoxifen and Radiotherapy

ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.

Group Type: EXPERIMENTAL

Tamoxifen

Intervention Type: DRUG

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.

Radiotherapy

Intervention Type: RADIATION

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.

Sequential radiotherapy and tamoxifen

ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.

Group Type: ACTIVE_COMPARATOR

Tamoxifen

Intervention Type: DRUG

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.

Radiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anusheel Munshi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anusheel Munshi, MD

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital

Locations

Tata Memorial Center

Pārel, Mumbai, India

Site Status: RECRUITING

Countries

India

Facility Contacts

Anusheel Munshi, MD

Role: primary

-91-22-24177000 ext. 7144

Other Identifiers

349

Identifier Type: -

Identifier Source: org_study_id