Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sacituzumab Govitecan In TNBC (NeoSTAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230109
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by (Responsible Party):
Aditya Bardia, Massachusetts General Hospital

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Invasive Breast Cancer Triple Negative Breast Cancer ER-Negative Breast Cancer PR-Negative Breast Cancer HER2-negative Breast Cancer Drug: Sacituzumab Govitecan Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sacituzumab Govitecan

- 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.
Drug: Sacituzumab Govitecan
Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles
Other Name: IMMU-132




Primary Outcome Measures :
  1. Pathological complete response(pCR) rate with sacituzumab govitecan [ Time Frame: 12 Weeks ]
    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 :
  1. 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 ]
    Kaplan-Meier methods and descriptive statistics

  2. 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 ]
    Kaplan-Meier methods and descriptive statistics

  3. Change in Breast Conserving Surgery Rate (BCS) rate [ Time Frame: 12 Weeks ]
    RCB calculator: http:// RCB calculator: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3

  4. Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: Baseline to 12 weeks ]
    CTCAE v5.0

  5. Assessment of Quality of life (QOL) [ Time Frame: Baseline up to 12 Weeks ]
    EORTC questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230109


Contacts
Layout table for location contacts
Contact: Aditya Bardia, MD, MPH 617-724-4800 ABARDIA1@PARTNERS.ORG

Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Neelam Desai, MD    617-667-2100      
Principal Investigator: Neelam Desai, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sara Tolaney, MD, MPH    617-632-3800      
Principal Investigator: Sara Tolaney, MD, MPH         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Aditya Bardia, MD, MPH    617-724-4800      
Principal Investigator: Aditya Bardia, MD, MPH         
Massachusetts General Hospital - North Shore Cancer Center Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Therese Mulvey, MD    978-882-6060      
Principal Investigator: Therese Mulvey, MD         
Massachusetts General Hospital at Newton-Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02462
Contact: Amy Comander, MD    617-219-1230      
Principal Investigator: Amy Comander, MD         
Sponsors and Collaborators
Aditya Bardia
Immunomedics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Aditya Bardia, MD, MPH Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Aditya Bardia, Sponsor Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04230109    
Other Study ID Numbers: 19-578
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aditya Bardia, Massachusetts General Hospital:
Invasive Breast Cancer
Triple Negative Breast Cancer
ER-Negative Breast Cancer
PR-Negative Breast Cancer
HER2-negative Breast Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases