Concomitant and Sequential Radiohormonotherapy in Adjuvant Breast Cancer

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.

Sex

Female

Minimum age

18 Years

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).

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• DERIVEDBourgier C, Kerns S, Gourgou S, Lemanski C, Gutowski M, Fenoglietto P, Romieu G, Crompton N, Lacombe J, Pelegrin A, Ozsahin M, Rosenstein B, Azria D. Concurrent or sequential letrozole with adjuvant breast radiotherapy: final results of the CO-HO-RT phase II randomized trial. Ann Oncol. 2016 Mar;27(3):474-80. doi: 10.1093/annonc/mdv602. Epub 2015 Dec 17. PMID 26681684
• DERIVEDAzria D, Belkacemi Y, Romieu G, Gourgou S, Gutowski M, Zaman K, Moscardo CL, Lemanski C, Coelho M, Rosenstein B, Fenoglietto P, Crompton NE, Ozsahin M. Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. Lancet Oncol. 2010 Mar;11(3):258-65. doi: 10.1016/S1470-2045(10)70013-9. Epub 2010 Feb 6.