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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. Identifier: NCT00208273
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 18, 2007
Information provided by:
Institut du Cancer de Montpellier - Val d'Aurelle

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole - Concomitant Drug: Letrozole - Sequential Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sub-cutaneous late toxicity [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Early toxicity
  2. Lung late toxicity
  3. Cosmetic results
  4. Local failure
  5. Relapse-free survival
  6. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208273

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CRLC Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
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Principal Investigator: David AZRIA, MD,PhD CRLC Val d'Aurelle

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00208273    
Other Study ID Numbers: CO-HO-RT/2004/31
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
Postmenopausal breast cancer, radiohormonotherapy sequences
ER+ and/or PgR+,
Postmenopausal Breast cancer,
Adjuvant setting
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs