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

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

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).

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Pulmonary Fibrosis
• Intervention / Treatment: Drug: Tamoxifen; Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Mumbai
    • Parel, Mumbai, India, 400012
      • Recruiting
      • Tata Memorial Center
      • Contact: Anusheel Munshi, MD; Phone Number: 7144 -91-22-24177000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of Lung fibrosis	Three years

Secondary Outcome Measures

Outcome Measure	Time Frame
Locoregional failure and distant failure	Three years

Collaborators and Investigators

• Sponsor: Tata Memorial Hospital
• Collaborators: Indian Council of Medical Research
• Investigators: Principal Investigator: Anusheel Munshi, MD, Tata Memorial Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 8, 2009
• First Submitted That Met QC Criteria: May 8, 2009
• First Posted (Estimate): May 11, 2009

Study Record Updates

• Last Update Posted (Estimate): August 30, 2011
• Last Update Submitted That Met QC Criteria: August 27, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: radiotherapy; Breast cancer; tamoxifen; Pulmonary fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Fibrosis; Breast Neoplasms; Pulmonary Fibrosis; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen
• Other Study ID Numbers: 349