Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients - Full Text View

Purpose

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).

Condition	Intervention	Phase
Pulmonary Fibrosis Breast Cancer	Drug: Tamoxifen Radiation: Radiotherapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Pulmonary Fibrosis

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:

Development of Lung fibrosis [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Locoregional failure and distant failure [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Concurrent Tamoxifen and Radiotherapy ARM 1 will receive Tamoxifen given concurrently with radiotherapy. Tamoxifen will continue for a period of 5 years.	Drug: Tamoxifen 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. Radiation: Radiotherapy 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.
Active Comparator: Sequential radiotherapy and tamoxifen ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.	Drug: Tamoxifen 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. Radiation: Radiotherapy 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.

Arms

Assigned Interventions

Experimental: Concurrent Tamoxifen and Radiotherapy

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

Drug: Tamoxifen

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.

Radiation: Radiotherapy

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.

Active Comparator: Sequential radiotherapy and tamoxifen

ARM-2 shall receive radiotherapy followed by tamoxifen sequentially. Again tamoxifen will continue for a period of 5 years.

Drug: Tamoxifen

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.

Radiation: Radiotherapy

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896155

Locations

India
Tata Memorial Center	Recruiting
Parel, Mumbai, India, 400012
Contact: Anusheel Munshi, MD -91-22-24177000 ext 7144

Sponsors and Collaborators

Tata Memorial Hospital

Indian Council of Medical Research

Investigators

Principal Investigator:

Anusheel Munshi, MD

Tata Memorial Hospital

More Information

No publications provided

Responsible Party:	Anusheel Munshi, Associate Professor, Tata Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00896155 History of Changes
Other Study ID Numbers:	349
Study First Received:	May 8, 2009
Last Updated:	August 27, 2011
Health Authority:	India: Data Safety and Monitoring Committee, Tata Memorial Hospital India

Keywords provided by Tata Memorial Hospital:

Breast cancer
Pulmonary fibrosis
tamoxifen
radiotherapy

Additional relevant MeSH terms:

Pulmonary Fibrosis
Breast Diseases
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Breast Neoplasms
Fibrosis
Neoplasms by Site
Neoplasms
Pathologic Processes
Tamoxifen

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 16, 2013

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