Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet.
Breast cancer is the most common form of cancer among women in North America, Europe and Latin America. Because nearly 80% of breast cancers are endocrine-responsive tumors, the majority of patients candidates for adjuvant chemotherapy (CT) are also candidates for endocrine therapy (ET). The optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet. In patients with hormone receptor positive early stage breast cancer who are candidates to adjuvant chemotherapy and endocrine therapy, the optimal timing for the integration of these two treatment modalities has not been clearly defined yet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)
Disease- free Survival (DFS)
the primary outcome indicator will be the so called DFS, defined as time elapsing between the date of randomization and the date of one of the following events, whichever occurs first, assessed up to 15 years: * Local Recurrence of disease * Regional recurrence of disease * Distant recurrence of disease * Contralateral invasive or intraductal breast cancer * Second primary malignancy other than breast * Death for any cause
Time frame: up to 15 years
Overall Survival (OS)
Time frame: time between the date of randomization up to the date of death for any cause, assessed up to 15 years.
Translational Study: genomic analysis
Expression of genes associated with ER and Ki67 expression will be analyzed by Real Time polymerase chain reaction (PCR) on RNA extracted from formalin-fixed paraffin embedded (FFPE) sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive) and will be correlated with disease free survival.
Time frame: up to 15 years
Translational Study: epigenetic analysis
miRNA expression analysis by real time PCR and DNA methylation analysis by pyrosequencing will be assessed on FFPE sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive)
Time frame: up to 15 years
Translational Study: proteomic analysis
The different proteomic profiles identified in FFPE sections of hormone receptors positive G2 tumors will be correlated with DFS
Time frame: up to 15 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ospedale Santo SpiritoH
Casale Monferrato, AL, Italy
Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2
Fabriano, AN, Italy
A.O. San Giuseppe Moscati
Avellino, AV, Italy
Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico
Bari, BA, Italy
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, BG, Italy
Azienda Ospedaliera Treviglio-Caravaggio
Treviglio, BG, Italy
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'
Benevento, BN, Italy
Presidio Ospedaliero 'Antonio Perrino'
Brindisi, BR, Italy
ASST Spedali Civili - P.O. Spedali Civili
Brescia, BS, Italy
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