Status:

UNKNOWN

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

Lead Sponsor:

Tata Memorial Hospital

Collaborating Sponsors:

Indian Council of Medical Research

Conditions:

Pulmonary Fibrosis

Breast Cancer

Eligibility:

FEMALE

Phase:

PHASE3

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 co...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2013

Estimated Enrollment :

260 Patients enrolled

Trial Details

Trial ID

NCT00896155

Start Date

December 1 2008

End Date

December 1 2013

Last Update

August 30 2011

Active Locations (1)

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1

Tata Memorial Center

Pārel, Mumbai, India, 400012