Sacituzumab Govitecan In TNBC

NCT04230109 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 19-578
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 5

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)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response(pCR) rate with sacituzumab govitecan

  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.

  12 Weeks

Secondary Outcomes (5)

• Disease-Free Survival

  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

• Overall Survival

  defined as the time from the first dose of study treatment to the date of death or last contact up to 36 months

• Change in Breast Conserving Surgery Rate (BCS) rate

  12 Weeks

• Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

  Baseline to 12 weeks

• Assessment of Quality of life (QOL)

  Baseline up to 12 Weeks

Study Arms (2)

Sacituzumab Govitecan (monotherapy cohort)

EXPERIMENTAL

\- 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 and Pembrolizumab (combination cohort)

EXPERIMENTAL

\- 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.

Drug: Sacituzumab Govitecan; Drug: Pembrolizumab

Interventions

Sacituzumab Govitecan DRUG

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

Also known as: IMMU-132

Sacituzumab Govitecan (monotherapy cohort); Sacituzumab Govitecan and Pembrolizumab (combination cohort)

Pembrolizumab DRUG

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

Sacituzumab Govitecan and Pembrolizumab (combination cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Gilead Sciences: collaborator

Study Sites (5)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Massachusetts General Hospital - North Shore Cancer Center

Danvers, Massachusetts, 01923, United States

RECRUITING

Massachusetts General Hospital at Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38092228 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan; pembrolizumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Spring, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Spring, MD

CONTACT

617-726-6500; LSPRING2@PARTNERS.ORG

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: July 14, 2020
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (5)