CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 200 enrolled
Drug / intervention
Doxorubicin +5 moredrug
Likely dose
Letrozole 2.5 mg orally daily plus abemaciclib 150 mg orally every 12 hours on continuous dosing schedule (up to 12 months, in 28-day cycles); or AC (doxorubicin 60 mg/m² and cyclophosphamide 600 mg/m² every 21 days for 4 cycles) followed by paclitaxel 80 mg/m² weekly for 12 weeks or docetaxel 100 mg/m² every 3 weeks for 4 cyclesAI-extracted
Key inclusion· 8
  • ✓Women aged ≥18 years
  • ✓Histologically confirmed primary invasive adenocarcinoma of the breast
  • ✓HR-positive (≥10% positive cells on IHC for ER and/or PgR) and HER2-negative tumors
  • ✓Ki67 ≥20% (intermediate/high risk) determined at central laboratory
Key exclusion· 8
  • ✕Prior anti-cancer treatment with therapeutic intent for current breast cancer
  • ✕Inflammatory breast cancer, multifocal/multicentric with ≥3 lesions, or bilateral breast cancers
  • ✕Serious/uncontrolled preexisting medical conditions (interstitial lung disease, severe dyspnea, renal impairment, GI surgery, inflammatory bowel disease, baseline Grade ≥2 diarrhea)
  • ✕Active systemic bacterial, fungal, or detectable viral infection (HIV, hepatitis B or C)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04293393
NCT04293393Phase 2Active
CompareCT.gov

Phase II, Randomized, Open-label, International, Multicenter Study to Compare Efficacy of Standard Chemotherapy vs. Letrozole Plus Abemaciclib as Neoadjuvant Therapy in HR-positive/HER2-negative High/Intermediate Risk Breast Cancer Patients

Spanish Breast Cancer Research Group·interventional·Posted Mar 3, 2020·Updated Mar 12, 2026

In Brief

A Phase 2 clinical trial evaluating Doxorubicin, Cyclophosphamide, and 4 other interventions for Early Breast Cancer. Active but no longer recruiting, targeting 200 participants across 28 sites.

Detailed Summary

Phase II, randomized, open-label, international, multicenter study to compare efficacy of standard chemotherapy vs. letrozole plus abemaciclib as neoadjuvant therapy in HR-positive/HER2-negative high/intermediate risk breast cancer patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Breast Cancer
CountriesSpain
CollaboratorsEli Lilly and Company

Timeline

Phase 2Active
20202021202220232024202520262027202820292030203120322033
First PostedMar 3, 2020
Enrollment StartOct 2, 2020
Primary CompletionJun 21, 2023
Study CompletionFeb 28, 2033
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.3 years ago

Interventions

Doxorubicindrug

Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.

Cyclophosphamidedrug

Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.

Taxanedrug

Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.

Letrozoledrug

Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles

Abemaciclibdrug

Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles

LHRH Analoguedrug

Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles