Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT00208273
First received: September 13, 2005
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Letrozole - Concomitant
Drug: Letrozole - Sequential
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • Sub-cutaneous late toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Early toxicity
  • Lung late toxicity
  • Cosmetic results
  • Local failure
  • Relapse-free survival
  • Overall survival

Enrollment: 150
Study Start Date: January 2005
Study Completion Date: February 2007
Arms Assigned Interventions
Experimental: A
Letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy.
Drug: Letrozole - Concomitant
Experimental: B
Letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy.
Drug: Letrozole - Sequential

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00208273

Locations
France
CRLC Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Novartis
Investigators
Principal Investigator: David AZRIA, MD,PhD CRLC Val d'Aurelle
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00208273     History of Changes
Other Study ID Numbers: CO-HO-RT/2004/31
Study First Received: September 13, 2005
Last Updated: December 13, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
Postmenopausal breast cancer, radiohormonotherapy sequences
ER+ and/or PgR+,
Postmenopausal Breast cancer,
Adjuvant setting

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014