NCT00896155

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

3 years

First QC Date

May 8, 2009

Last Update Submit

August 27, 2011

Conditions

Pulmonary FibrosisBreast Cancer

Keywords

Breast cancerPulmonary fibrosistamoxifenradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Development of Lung fibrosis

    Three years

Secondary Outcomes (1)

  • Locoregional failure and distant failure

    Three years

Study Arms (2)

Concurrent Tamoxifen and Radiotherapy

EXPERIMENTAL

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

Drug: TamoxifenRadiation: Radiotherapy

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.

Drug: TamoxifenRadiation: Radiotherapy

Interventions

TamoxifenDRUG

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.

Concurrent Tamoxifen and RadiotherapySequential radiotherapy and tamoxifen
RadiotherapyRADIATION

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.

Concurrent Tamoxifen and RadiotherapySequential radiotherapy and tamoxifen

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Center

Pārel, Mumbai, 400012, India

RECRUITING

MeSH Terms

Conditions

Pulmonary FibrosisBreast Neoplasms

Interventions

TamoxifenRadiotherapy

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTherapeutics

Study Officials

  • Anusheel Munshi, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 11, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

IN(1)