Clinical Trials /

Sacituzumab Govitecan In TNBC

NCT04230109

Description:

This research study is studying to see if Sacituzumab govitecan is effective and safe for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: - Sacituzumab govitecan

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Sacituzumab Govitecan In TNBC
  • Official Title: A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)

Clinical Trial IDs

  • ORG STUDY ID: 19-578
  • NCT ID: NCT04230109

Conditions

  • Invasive Breast Cancer
  • Triple Negative Breast Cancer
  • ER-Negative Breast Cancer
  • PR-Negative Breast Cancer
  • HER2-negative Breast Cancer

Interventions

DrugSynonymsArms
Sacituzumab GovitecanIMMU-132Sacituzumab Govitecan

Purpose

This research study is studying to see if Sacituzumab govitecan is effective and safe for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: - Sacituzumab govitecan

Detailed Description

      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational drug to learn whether the drug works in treating a
      specific disease."Investigational" means that the drug is being studied.

      This research study involves an experimental study treatment. The names of the study drugs
      involved in this study is:

      - Sacituzumab govitecan

      The research study procedures include screening for eligibility and study treatment including
      evaluations and follow up visits.

        -  Eligible participants will receive Sacituzumab govitecan for up to 12 weeks.

        -  This can be followed by standard chemotherapy at the discretion of the treating
           physician.

        -  It is expected that about 50 people will take part in this research study.

      The U.S. Food and Drug Administration (FDA) has not approved Sacituzumab govitecan as a
      treatment for any disease.

      Sacituzumab govitecan is an antibody-drug conjugate which means it's made up of an antibody
      attached to an anticancer drug. An antibody is a protein normally made the immune system.
      Sacituzumab govitecan is believed to work by binding the antibody portion of the drug in the
      tumor(s) while the anticancer drug portion works to prevent ancer cells from
      growing/spreading.
    

Trial Arms

NameTypeDescriptionInterventions
Sacituzumab GovitecanExperimental- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles. This can be followed by standard chemotherapy at the discretion of treating physician.
  • Sacituzumab Govitecan

Eligibility Criteria

        Inclusion Criteria:

          -  Female or male patients ≥ 18 years of age.

          -  Histologically confirmed diagnosis of invasive breast cancer, previously untreated.

          -  Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2
             negative (HER2-), invasive breast cancer. ER, PR, and HER2 positivity would be
             determined per ASCO/CAP guidelines by institutional (local) assessment. Patients with
             multi-focal and multicentric disease are eligible provided all histologically examined
             lesions are ER-/PR-/HER2- (local assessment). The need to biopsy additional lesions is
             at the discretion of the treating physician. Patients with bilateral invasive breast
             cancer are eligible provided all histologically examined lesions are ER-/PR-/HER2-
             (local assessment).

          -  Primary tumor (at least one lesion) 1 cm or greater measured by radiological imaging.
             Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, any primary tumor
             size is permissible. Absence of distant metastatic disease (AJCC TNM stage M0).
             Staging scans are not required and are per discretion of the treating physician.

          -  Pre- and postmenopausal women are eligible.

          -  ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)

          -  Ability to understand and the willingness to sign a written informed consent form
             (ICF). Patient has signed the ICF prior to any screening procedures being performed
             and is able to comply with protocol requirements, including research biopsy.

          -  Patient has adequate bone marrow and organ function as defined by the following
             laboratory values at screening:

          -  Absolute neutrophil count (ANC) ≥ 1,500 per mm3

          -  Platelets ≥ 100,000 per mm3

          -  Hemoglobin ≥9.0 g/dL

          -  INR ≤1.5

          -  Serum creatinine <1.5 mg/dL or creatinine clearance ≥50 mL/min

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN.

          -  Total bilirubin ≤1.5 x ULN or in patients with well-documented Gilbert's Syndrome
             direct bilirubin ≤1.5 x ULN.

        Exclusion Criteria:

          -  Inflammatory breast cancer, or locally recurrent breast cancer

          -  Participants currently receiving systemic therapy for any other malignancy or having
             received systemic therapy for a malignancy in the preceding 3 years.

          -  Uncontrolled inter-current illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia,or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Clinically significant, uncontrolled heart disease and/or cardiac reppolarization
             abnormality including any of the following:

               -  History of angina pectoris, symptomatic pericarditis, coronary artery bypass
                  graft (CABG) or myocardial infarction within 6 months prior to study entry.

               -  History of cardiac failure, known cardiomyopathy (LVEF < 50%; new LVEF assessment
                  is not specifically required for this trial), significant/symptomatic
                  bradycardia, Long QT syndrome, family history of idiopathic sudden death or
                  congenital long QT syndrome or any of the following:

          -  Known risk to prolong the QT interval or induce Torsade's de Pointes.

          -  Uncorrected hypomagnesemia or hypokalemia.

          -  Systolic Blood Pressure (SBP) >160 mmHg or <90 mmHg.

          -  Bradycardia (heart rate <50 at rest), by ECG or pulse. On screening, inability to
             determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF
             >470 screening ECG

          -  Pregnant or breast-feeding women are excluded from this study because the safety of
             study medications is not established.

          -  Known HIV-positive participants on combination antiretroviral therapy are ineligible.

          -  These participants are at increased risk of lethal infections when treated with
             marrow-suppressive therapy. Separate HIV testing for this trial is not required.
             Similarly, separate Hepatitis B or C testing for this trial is not required, but
             patients with known (or history) of hepatitis B positive, or hepatitis C positive
             infection will be excluded
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathological complete response(pCR) rate with sacituzumab govitecan
Time Frame:12 Weeks
Safety Issue:
Description:pCR is defined as no residual invasive carcinoma in the breast and in the lymph node. The two-sided 95% CIs for pCR rate will be calculated.

Secondary Outcome Measures

Measure:Disease-Free Survival
Time Frame:Time from the first dose of study treatment to disease recurrence/progression by RECIST v1.1 or death due to any cause, up to 36 months
Safety Issue:
Description:Kaplan-Meier methods and descriptive statistics
Measure:Overall Survival
Time Frame:defined as the time from the first dose of study treatment to the date of death or last contact up to 36 months
Safety Issue:
Description:Kaplan-Meier methods and descriptive statistics
Measure:Change in Breast Conserving Surgery Rate (BCS) rate
Time Frame:12 Weeks
Safety Issue:
Description:RCB calculator: http:// RCB calculator: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Measure:Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time Frame:Baseline to 12 weeks
Safety Issue:
Description:CTCAE v5.0
Measure:Assessment of Quality of life (QOL)
Time Frame:Baseline up to 12 Weeks
Safety Issue:
Description:EORTC questionnaire

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Aditya Bardia

Trial Keywords

  • Invasive Breast Cancer
  • Triple Negative Breast Cancer
  • ER-Negative Breast Cancer
  • PR-Negative Breast Cancer
  • HER2-negative Breast Cancer

Last Updated

January 14, 2020