Sacituzumab Govitecan In TNBC

NCT ID: NCT04230109

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2029-10-31

Brief Summary

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)

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 (SG)
• Pembrolizumab (combination therapy with SG)

The study is a umbrella study multi-arm phase II study of neoadjuvant SG-based therapy in patients with localized BC. The first cohort involves SG monotherapy. After the monotherapy cohort completes enrollment, the combination therapy cohort (SG with pembrolizumab) for patients with localized BC will open.

Future planned arms include SG with/without pembrolizumab for patients with Hormone Receptor positive (HR+) breast cancer and inflammatory breast cancer (IBC).

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 patients with metastatic TNBC.

Sacituzumab govitecan (SG) 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 cancer cells from growing/spreading.

After the SG monotherapy cohort completes enrollment, the combination therapy cohort (SG with immunotherapy) will open.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sacituzumab Govitecan (monotherapy cohort)

• 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.

Group Type: EXPERIMENTAL

Sacituzumab Govitecan

Intervention Type: DRUG

Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)

Sacituzumab Govitecan and Pembrolizumab (combination cohort)

• 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.
• Pembrolizumab via iv, predetermined dosage per protocol, IV, 1 day per each 21-day cycle, for 4 cycles.
• This can be followed by standard chemotherapy at the discretion of treating physician.

Group Type: EXPERIMENTAL

Sacituzumab Govitecan

Intervention Type: DRUG

Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)

Interventions

Sacituzumab Govitecan

Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)

Intervention Type: DRUG

Other Intervention Names

IMMU-132

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laura M. Spring, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Spring, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Massachusetts General Hospital - North Shore Cancer Center

Danvers, Massachusetts, United States

Site Status: RECRUITING

Massachusetts General Hospital at Newton-Wellesley Hospital

Newton, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Spring, MD

Role: CONTACT

LSPRING2@PARTNERS.ORG

617-726-6500

Facility Contacts

Neelam Desai, MD

Role: primary

617-667-2100

Sara Tolaney, MD, MPH

Role: primary

617-632-3800

Laura Spring, MD

Role: primary

LSPRING2@PARTNERS.ORG

617-726-6500

Therese Mulvey, MD

Role: primary

978-882-6060

Amy Comander, MD

Role: primary

617-219-1230

References

Spring LM, Tolaney SM, Fell G, Bossuyt V, Abelman RO, Wu B, Maheswaran S, Trippa L, Comander A, Mulvey T, McLaughlin S, Ryan P, Ryan L, Abraham E, Rosenstock A, Garrido-Castro AC, Lynce F, Moy B, Isakoff SJ, Tung N, Mittendorf EA, Ellisen LW, Bardia A. Response-guided neoadjuvant sacituzumab govitecan for localized triple-negative breast cancer: results from the NeoSTAR trial. Ann Oncol. 2024 Mar;35(3):293-301. doi: 10.1016/j.annonc.2023.11.018. Epub 2023 Dec 12.

Reference Type: DERIVED

PMID: 38092228 (View on PubMed)

Other Identifiers

19-578

Identifier Type: -

Identifier Source: org_study_id