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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 June 2021 |
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Main ID: |
NCT00208273 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer
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Scientific title:
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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 |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00208273 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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David AZRIA, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CRLC Val d'Aurelle |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Letrozole - Sequential
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Drug: Letrozole - Concomitant
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Primary Outcome(s)
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Sub-cutaneous late toxicity
[Time Frame: 2 years]
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Secondary Outcome(s)
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Local failure
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Overall survival
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Relapse-free survival
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Cosmetic results
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Early toxicity
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Lung late toxicity
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Secondary ID(s)
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CO-HO-RT/2004/31
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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