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| Name | Class |
|---|---|
| Indian Council of Medical Research | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent Tamoxifen and Radiotherapy | Experimental | ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years. |
|
| Sequential radiotherapy and tamoxifen | Active Comparator | ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Lung fibrosis | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional failure and distant failure | Three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anusheel Munshi, MD | Tata Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Memorial Center | Recruiting | Pārel | Mumbai | 400012 | India |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
| Radiotherapy | 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. |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |