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ABCSG 64 / neoGRACE Study details *


An open-label, two-arm, randomized phase II study of Sacituzumab Govitecan vs Standard of Care as neoadjuvant therapy for endocrine non-responsive ER+/HER2-negative early breast cancer

Study start: Q4/2026
Coordinating Investigators: Christian Singer, Vienna
Michael Gnant, Vienna
Sample size: 80 (national)
Study design:
(Click to enlarge)		 ABCSG 64_Study design

Treatment:

Participants will first receive an aromatase inhibitor (AI) during a 4 -week run-in phase. Following assessment of the Ki-67 value after approximately three weeks, participants with evidence of endocrine non-responsiveness will be randomized in a 1:1 ratio to one of the treatment arms:  

  • Arm A: Sacituzumab govitecan (SG)
  • Arm B: Chemotherapy (SoC)

Primary Objective:

To evaluate the efficacy of neoadjuvant sacituzumab govitecan (SG) vs. SoC in endocrine non-responsive early breast cancer patients, when measured by pCR at the time of surgery

 Secondary Objectives

  • To evaluate the efficacy of neoadjuvant SG vs. SoC in endocrine non-responsive early breast cancer, when measured by RCB at the time of surgery (descriptive)
  • To determine the efficacy of neoadjuvant SC vs. SoC in endocrine non-responsive early breast cancer measured by long-term outcome

Safety Objective

  • To evaluate the safety and tolerability of neoadjuvant SC vs. SoC in endocrine non-responsive early breast cancer

Patient Reported Outcome (PRO) Objective

  • To evaluate PRO of neoadjuvant SG vs. SoC in endocrine non-responsive early breast cancer

Translational Objectives

  • To identify prognostic and predictive markers in endocrine non-responsive early breast cancer
  • To study additional research questions / to perform additional analyses from biological material and / or clinical as well as imaging data

Patient population

  • The target population for this clinical trial comprises participants with ER-positive/HER2-negative early or locally advanced breast cancer (AJCC v8.0 Stage IIA–III) who have an indication for chemotherapy and have not received prior systemic therapy for breast cancer.
  • In addition, participants who discontinue study ABCSG 61 due to their endocrine response profile may be enrolled in ABCSG 64, provided that all applicable eligibility criteria are met.

 * The information provided is based on Study Protocol Version 1.0. Study sites must refer to the currently approved protocol version.

 


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