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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00896155

Acronym

CONSET

Enrollment

260

Registered

2009-05-11

Start date

2008-12-31

Completion date

2013-12-31

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Pulmonary Fibrosis

Keywords

Breast cancer, Pulmonary fibrosis, tamoxifen, radiotherapy

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).

Interventions

DRUGTamoxifen

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.

RADIATIONRadiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
Development of Lung fibrosis	Three years

Secondary

Measure	Time frame
Locoregional failure and distant failure	Three years

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026