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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


Phase 3
N/A
N/A
Open (Enrolling)
Female
Pulmonary Fibrosis, Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Development of Lung fibrosis

Outcome Time Frame:

Three years

Safety Issue:

No

Principal Investigator

Anusheel Munshi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Hospital

Authority:

India: Data Safety and Monitoring Committee, Tata Memorial Hospital India

Study ID:

349

NCT ID:

NCT00896155

Start Date:

December 2008

Completion Date:

December 2013

Related Keywords:

  • Pulmonary Fibrosis
  • Breast Cancer
  • Breast cancer
  • Pulmonary fibrosis
  • tamoxifen
  • radiotherapy
  • Breast Neoplasms
  • Fibrosis
  • Pulmonary Fibrosis

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