Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

June 1, 2021 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sub-cutaneous late toxicity
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Overall survival
Relapse-free survival
Cosmetic results
Early toxicity
Lung late toxicity
Local failure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Collaborators

Novartis

Investigators

  • Principal Investigator: David AZRIA, MD,PhD, CRLC Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-HO-RT/2004/31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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