Status:
COMPLETED
Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborating Sponsors:
Novartis
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
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 sta...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00208273
Start Date
January 1 2005
End Date
February 1 2007
Last Update
June 2 2021
Active Locations (1)
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1
CRLC Val d'Aurelle
Montpellier, France, 34298