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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Anusheel Munshi, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00896155
First received: May 8, 2009
Last updated: August 27, 2011
Last verified: August 2011
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Breast Neoplasms
Fibrosis
Pulmonary Fibrosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
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 July 10, 2014