Home » ABCSG Studies » Studies open for Enrollment » ABCSG 63 / ERIKA » ABCSG 63 / ERIKA Study Details*

ABCSG 63 / ERIKA Study Details*


Elacestrant and RIbociclib in Ki67-tested endocrine responsive breAst cancer

An open-label, two-arm, randomized, phase II study of elacestrant plus ribociclib vs. AI (plus GnRH agonist in pre-/perimenopausal women and men) plus ribociclib as neoadjuvant therapy for endocrine-responsive HER2-negative early breast cancer

Studienstart: Q3/2025
Coordinating Investigators: Christian Singer, Vienna
Michael Gnant, Vienna
Participants: 120 (Austria, Germany)
Study Design
(Click to enlarge)		 ABCSG 63 / ERIKA Study Details

Treatment:

Patients will be randomized in a 1:1 ratio to receive in step 1 either

  • 1 cycle (= 28 days) of 400 mg elacestrant dihydrochloride qd plus 400 mg ribociclib qd in arm A

OR

  • 1 cycle (= 28 days) of AI (and GnRH agonist in pre-/perimenopausal women and men) plus 400 mg ribociclib qd in arm B

to identify endocrine-responsive tumors.

Tumors which exhibit a Ki-67 of ≤10 % at C1D22 visit as determined by local pathologist will be considered “endocrine responsive” and these patients will continue to receive treatment in step 2 – dependent on the initial randomization – either

  • 5 cycles (= 5 x 28-day cycles) of 400 mg elacestrant dihydrochloride qd plus 400 mg ribociclib qd in arm A

OR

  • 5 cycles (= 5 x 28-day cycles) of AI (and GnRH agonist in pre-/perimenopausal women and men) plus 400 mg ribociclib qd in arm B

Tumors which exhibit a Ki-67 of >10 % at C1D22 visit as determined by local pathologist will be considered “non-endocrine responsive” and these patients will have an EOSV scheduled and will receive further treatment at the discretion of the investigator.

Primary Objective:

  • To evaluate the superiority of the study treatment when measured by modified PEPI score at the time of surgery

Secondary Objectives:

  • To evaluate Ki-67 (at C1D22), RCB (at surgery) and pCR (at surgery)
  • To evaluate changes in the radiological tumor size from screening to 3 months of treatment and to pre-surgery

Safety Objective:

  • To evaluate the safety and tolerability

Patient Reported Outcome Objectives:

  • To evaluate quality of life at screening, at C1D22 visit, at surgery visit as well as at EOSV

Translational Objective:

  • To study additional research questions / to perform additional analyses from biological material and / or clinical data that have been collected within this trial

Patient Population

  • The target population of this study consists of patients (women or men) with ER+/HER2- early breast cancer (stage cT1c-4a-c, cN0-3, M0 per AJCC v8)

*Study information is displayed as described in study protocol V2.0. Sites must adhere to the currently approved version of the protocol.


Share on


Top