Sacituzumab Govitecan In TNBC (NeoSTAR)

July 16, 2026 updated by: Laura M. Spring, MD, Massachusetts General Hospital

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Laura Spring, MD
        • Contact:
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Sara Tolaney, MD, MPH
          • Phone Number: 617-632-3800
        • Principal Investigator:
          • Sara Tolaney, MD, MPH
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Beth Israel Deaconess Medical Center
      • Danvers, Massachusetts, United States, 01923
        • Recruiting
        • Massachusetts General Hospital - North Shore Cancer Center
        • Principal Investigator:
          • Therese Mulvey, MD
        • Contact:
          • Therese Mulvey, MD
          • Phone Number: 978-882-6060
      • Newton, Massachusetts, United States, 02462
        • Recruiting
        • Massachusetts General Hospital at Newton-Wellesley Hospital
        • Contact:
          • Amy Comander, MD
          • Phone Number: 617-219-1230
        • Principal Investigator:
          • Amy Comander, MD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female or male patients ≥ 18 years of age.
  • Histologically confirmed diagnosis of invasive breast cancer, previously untreated.

  • Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:

    • Not a woman of childbearing potential (WOCBP) OR

    • A WOCBP who agrees to use effective contraceptive measures that have a failure rate of less than 1% per year from the initiation of treatment through at least 6 months b. after the last dose of study treatment. WOCBP must agree to 1 of the following contraceptive methods:

      • Complete abstinence from intercourse of reproductive potential, or

      • Consistent and correct use of 1 of the following methods of birth control:

        • Nonhormonal intrauterine device (IUD); Hormonal IUD in conjunction with a barrier method; Female sterilization (have had surgical bilateral oophorectomy with or; without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; Vasectomy in the male partner (upon medical assessment of surgical success)

  • Male patients with female partners of childbearing potential must practice

    • Complete abstinence from intercourse of reproductive potential
    • Have a surgically successful vasectomy upon medical assessment, or
    • Use condoms plus partner use of a contraceptive method with a failure rate of <1% per year during treatment and until 3 months after last dose of study drug.
  • 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
    • PT-INR ≤1.5 x institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPPT is within therapeutic range of intended use of anticoagulants (for patients receiving pembrolizumab only).
    • Serum creatinine <1.5 mg/dL or creatinine clearance ≥50 mL/min (via the Cockcroft-Gault formula) for participants with creatinine levels above institutional upper limit of normal (ULN)
    • Adequate hepatic function (bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5 X ULN and serum albumin > 3 g/dL).

Exclusion Criteria:

  • Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years. (Concurrent endocrine therapy allowed in the adjuvant setting. Concurrent GnRH agonists allowed in any setting. Concurrent CDK4/6 inhibitor not allowed in any setting.)
  • 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 repolarization 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. Higher blood pressure is permissible per discretion of treating physician; 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.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to enrollment are eligible for this trial. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Participants who are not good candidates for the study (as per investigator judgement)
  • History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Sacituzumab Govitecan
Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
Other Names:
  • IMMU-132
Experimental: 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.
Drug: Sacituzumab Govitecan
Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
Other Names:
  • IMMU-132
Drug: Pembrolizumab
Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
Time Frame: 12 Weeks
RCB calculator: http:// RCB calculator: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
12 Weeks
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: Baseline to 12 weeks
CTCAE v5.0
Baseline to 12 weeks
Assessment of Quality of life (QOL)
Time Frame: Baseline up to 12 Weeks
EORTC questionnaire
Baseline up to 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Spring, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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