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

Tata Memorial Hospital

Status and phase: Unknown; Phase 3

Conditions: Pulmonary Fibrosis; Breast Cancer

Treatments: Radiation: Radiotherapy; Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT00896155

349

Details and patient eligibility

About

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).

Enrollment: 260 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Concurrent Tamoxifen and Radiotherapy

Experimental group

Description:

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

Treatment:

Drug: Tamoxifen

Radiation: Radiotherapy

Sequential radiotherapy and tamoxifen

Active Comparator group

Description:

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

Treatment:

Drug: Tamoxifen

Radiation: Radiotherapy