NCT02918084

CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

A Phase III Study Comparing the Concurrent Versus the Sequential Administration of Chemotherapy and Aromatase Inhibitors, as Adjuvant Treatment of Post-menopausal Patients With Endocrine-responsive Early Breast Cancer.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Anastrozole or Letrozole or Exemestane	Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
DRUG	Anastrozole or Letrozole or Exemestane	Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)

Timeline

• Start date: 2013-06-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2016-09-28
• Last updated: 2024-05-08

Locations

74 sites across 1 country: Italy