A phase 3 study of sacituzumab govitecan in refractory/relapsed triple negative breast cancer, sponsored by Immunomedics, Inc.

ClinicalTrials.gov identifier: NCT02574455

now recruiting eligible patients

Study description

ASCENT is a multicenter, open-label, randomized, phase 3 study in patients with metastatic triple negative breast cancer (TNBC) refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Learn about eligibility requirements for the ASCENT trial.

Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization. Learn more about the ASCENT trial design.

  • Subjects will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first
  • Tumor progression leading to treatment withdrawal will be assessed by the investigator
  • CT scans will be obtained at least every 6 weeks for 36 weeks and every 9 weeks thereafter until the occurrence of progression of disease requiring discontinuation of further treatment under the trial
  • All subjects, including those prematurely terminating study participation, will be followed every 4 weeks for survival follow-up

Outcome measures include: progression-free survival, overall survival, objective response rate, duration of response, and time to onset of response. See full information about outcome measures.

Find a list of ASCENT Trial participating centers here.

For questions or more information about the ASCENT Trial, please contact us.

For more information about the antibody-drug conjugate, sacituzumab govitecan, please visit immunomedics.com or email IMMU132@immunomedics.com.

Trial Design

Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization from 1 of the 4 allowed regimens. Subjects will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first.

ASCENT study design

ASCENT Study Design - Metastatic triple negative breast cancer (TNBC). ASCENT Study Design - Metastatic triple negative breast cancer (TNBC).

Patient criteria

Patients with metastatic TNBC who are refractory/relapsed after 2 or more prior standard-of-care chemotherapies, including taxanes, for advanced disease. See Eligibility for the complete list of inclusion and exclusion criteria.

Study arms

Investigational:
sacituzumab govitecan

10 mg/kg on Days 1 and 8 of 21-day cycles

Control:
1 of the following 4 TPC regimens (no combinations are permitted):

Eribulin

Capecitabine

Gemcitabine

Vinorelbine

Outcome measures

Primary outcome measure

  1. Progression-free survival (PFS)

Secondary outcome measures

  1. Overall survival (OS): OS will be compared between the 2 treatment groups. PFS will be measured by an independent, centralized, and blinded group of radiology experts who will be assessing tumor response using RECIST 1.1 criteria. FDA definitions and guidance as described in Guidance for Industry.
  2. Objective response rate (ORR): ORR will be compared between the 2 treatment groups.
  3. Duration of response: Duration of response will be compared between the 2 treatment groups.
  4. Time to onset of response: Time to onset of response will be compared between the 2 treatment groups.

Eligibility

Key entry criteria

  • Women or men >18 years of age with histologically or cytologically confirmed TNBC
  • Refractory to or relapsed after at least 2 prior standard therapeutic regimens for advanced/metastatic TNBC, including a taxane
        - Prior use of taxane-based regimens in localized setting or platinum-containing regimens is permitted
  • ECOG performance score of 0 or 1; adequate hematology, renal, and hepatic function
  • Brain MRI must be done for patients with brain metastasis and patient must have had stable CNS disease for at least 4 weeks. A maximum of 15% (N=74) of patients with brain metastases will be included in this trial.