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Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00208273
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 18, 2007
Sponsor:
Collaborator:
Novartis
Information provided by:
Institut du Cancer de Montpellier - Val d'Aurelle

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date December 18, 2007
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
Sub-cutaneous late toxicity [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Sub-cutaneous late toxicity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Early toxicity
  • Lung late toxicity
  • Cosmetic results
  • Local failure
  • Relapse-free survival
  • Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer
Official Title  ICMJE A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors
Brief Summary This trial will compare grade 2 or greater late skin toxicities of concomitant letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for postmenopausal women with receptor (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive tumors. Each drug will be prescribed for 5 years.
Detailed Description

This trial is an open-label randomized multicenter phase II study.

A ratio of 1 to 1 will be used for the randomization process between the two arms:

  • Arm A : Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy.
  • Arm B : Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy.

All patients will be followed every 3 months for toxicities, disease status and for survival until death.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Letrozole - Concomitant
  • Drug: Letrozole - Sequential
Study Arms  ICMJE
  • Experimental: A
    Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy.
    Intervention: Drug: Letrozole - Concomitant
  • Experimental: B
    Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy.
    Intervention: Drug: Letrozole - Sequential
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Compliant postmenopausal women
  • Conservative breast cancer surgery
  • Extension evaluation of disease will be proven negative
  • Patients with tumor negative margins
  • Patients will be classified as T1, T2, T3; Sentinel node negative, N0, N1 or N2; M0.
  • Receptor positive tumors (ER and/or PgR = 10 fmol/mg cytosol protein; or = 10% of the tumor cells positive by immunocytochemical evaluation).
  • Adequate marrow function (polynuclear neutrophils >= 1200.10^9/l, platelets >= 100.10^9/l, and hemoglobin >= 10 g/dl).
  • Hepatic function (bilirubin >= 30 µmol/l, ALT (SGPT) or AST (SGOT) >= 1.5 x upper limit of the institution) and cholesterol level <2 x upper limit of the institution.
  • Must be geographically accessible for follow-up.
  • Written and dated informed consent

Exclusion Criteria:

  • Patients with distant metastases.
  • Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast.
  • Patients staged T4 or N3 or treated by not conservative surgery (radical mastectomy).
  • Patients with neoadjuvant chemotherapy or hormonal therapy.
  • Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years.
  • Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
  • Patients treated with systemic investigational drugs within the past 30 days.
  • Breast cancer chemoprevention with anti-estrogens
  • Hormone replacement therapy (HRT) not stopped at least 4 weeks before randomization
  • Patients known to be HIV positive (no specific tests are required to determine the eligibility).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00208273
Other Study ID Numbers  ICMJE CO-HO-RT/2004/31
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: David AZRIA, MD,PhD CRLC Val d'Aurelle
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP