RECRUITING

Sacituzumab Govitecan In TNBC

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)

Official Title

A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)

Quick Facts

Study Start:2020-07-14

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04230109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Laura Spring, MD

CONTACT

617-726-6500

LSPRING2@PARTNERS.ORG

Principal Investigator

Laura Spring, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Massachusetts General Hospital

Boston, Massachusetts, 02115

United States

Massachusetts General Hospital - North Shore Cancer Center

Danvers, Massachusetts, 01923

United States

Massachusetts General Hospital at Newton-Wellesley Hospital

Newton, Massachusetts, 02462

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Laura Spring, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-14

Study Completion Date2026-10

Study Record Updates

Study Start Date2020-07-14

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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