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Breast CancerPhase 2NCT04468061

Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC

A Phase 2 study testing Sacituzumab Govitecan and Pembrolizumab in people with Breast Cancer and Triple Negative Breast Cancer, run by Dana-Farber Cancer Institute at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Govitecan and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
15 sitesUnited States
Study dates
20 Jul 2020to 1 Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
  • Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines. If a patient has more than one histological result, the most recent sample will be considered for inclusion.
  • Participants must have PD-L1-negative metastatic breast cancer defined as less than 1% expression of PD-L1 on tumor-infiltrating immune cells (IC) by the PD-L1 IHC SP142 assay or a Combined Positive Score (CPS) less than 10 by the PD-L1 IHC 22C3 assay measured with standard of care testing.
  • Participants must be treatment-naïve in the metastatic setting.
  • Participants must have evaluable or measurable disease per RECIST 1.1. Patients with bone only disease will be allowed to participate.
  • Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline. Previously collected archival tissue will also be obtained on all participants. Tissue needs to be located and availability confirmed at time of registration (see Section 9 for more details). Participants must agree to a mandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely accessible.
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  • Prior chemotherapy: Participants must have received no prior chemotherapy for metastatic breast cancer and must have discontinued all chemotherapy at least 28 days prior to study treatment initiation. No prior irinotecan or topoisomerase I-containing antibody drug conjugates in the metastatic or neo/adjuvant setting are allowed. All toxicities related to prior chemotherapy must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified per protocol, except alopecia can be any grade and neuropathy can be grade 2 or lower.
  • Prior biologic therapy: Patients must have received no prior biologic therapy for metastatic breast cancer and discontinued all biologic therapy at least 28 days prior to study treatment initiation. All toxicities related to prior biologic therapy must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified per protocol.
  • Prior radiation therapy: Patients may have received prior radiation therapy. Radiation therapy must be completed at least 7 days prior to study treatment initiation, and all toxicities related to prior radiation therapy must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified per protocol. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Previously treated brain metastases are permitted, with the following provisions:
  • Prior SRS should complete ≥ 7 days before study treatment initiation
  • Prior WBRT should complete ≥ 7 days before study treatment initiation.
  • Any corticosteroid use for brain metastases must have been discontinued for ≥ 7 days prior to study treatment initiation.
  • The subject is ≥ 18 years old.
  • ECOG performance status 0-1 (Karnofsky > 60%, see Appendix A).
  • Participants must have normal organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,000/mcL
  • Platelets ≥100,000/mcL
  • Hemoglobin ≥ 9.0 g/dl
  • INR/PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant
  • Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)(or ≤2.0 x ULN in patients with documented Gilbert's Syndrome)
  • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or ≤5 × institutional ULN for participants with documented liver metastases
  • Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN.
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to study treatment initiation. Childbearing potential is defined as participants who have not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
  • Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception. Contraception is required starting with the first dose of study medication through 180 days (6 months) after the last dose of study medication. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with pembrolizumab and 3 months after the last dose of study treatment
  • Participants on bisphosphonates or RANK ligand inhibitors may continue receiving therapy during study treatment and also may initiate therapy with these agents on study if clinically indicated.
  • The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.

Who cannot join

  • Has received prior systemic anti-cancer therapy, including investigational agents, within 4 weeks of study treatment initiation or during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed).
  • Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan (IMMU-132). Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic disease.
  • Prior hypersensitivity to pembrolizumab or the excipients of pembrolizumab or sacituzumab govitecan (IMMU-132 therapy).
  • Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) *28 allele homozygosity, which is associated with increased risk for neutropenia and diarrhea related to irinotecan. Note: Concurrent administration of strong UGT1A1 inhibitors or inducers is not allowed during the course of the study.
  • Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
  • Major surgery within 2 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.
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  • Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness/social situation that would limit compliance with study requirements in the opinion of the treating investigator.
  • Participant has a medical condition that requires chronic systemic steroid therapy (> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and has required such therapy in the last 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.
  • Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study principal investigator to determine eligibility.
  • Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as detected HCV RNA [qualitative]) infection. HIV-positive participants are ineligible due to the potential for pharmacokinetic interactions of combination antiretroviral therapy with study drugs and the increased risk of fatal infections when treated with marrow-suppressive therapy. Note: No testing for HIV, Hepatitis B, or Hepatitis C is required unless mandated by local health authority.
  • The participant has received a live vaccine within 28 days prior to study treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. The use of the inactivated seasonal influenza vaccine is allowed.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • It is unknown whether pembrolizumab is excreted in human milk. Since many drugs are excreted in human milk, and because of the potential for serious adverse reactions in the nursing infant, participants who are breast-feeding are not eligible for enrollment.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ana C Garrido-Castro, MD contact

617-632-6409

Ana_Garrido-Castro@dfci.harvard.edu

15 sites in 1 country

United States15 sites, 15 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Ana C. Garrido-Castro, MD, 617-632-6409, Ana_Garrido-Castro@dfci.harvard.edu

    Ana C. Garrido-Castro, MD

    Recruiting

  • Eastern Maine Medical Center

    Brewer, Maine, 04412

    Sarah Sinclair, DO, ssinclair@emhs.org

    Sarah Sinclair, DO

    Recruiting

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Emily Ray, MD, emmi@ad.unc.edu

    Emily Ray, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Abirami Sivapiragasam, MD

    sivapira@musc.edu

    Recruiting

  • Sarah Cannon Research Institute

    Chattanooga, Tennessee, 37404

    Brooke R Daniel, MD, bdaniel@tnonc.com

    Brooke R Daniel, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Rita Nanda, MD, rnanda@medicine.bsd.uchicago.edu

    Rita Nanda, MD

    Recruiting

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

    Julie Specht, MD, julie.specht@thechristhospital.com

    Julie Specht, MD

    Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio, 43212

    Margaret Gatti-Mays, MD, margaret.gatti-mays@osumc.edu

    Margaret Gatti-Mays, MD

    Recruiting

  • DFCI @ Foxborough

    Foxborough, Massachusetts, 02035

    Natalie Sinclair, MD, Nsinclair1@partners.org

    Natalie Sinclair, MD

    Recruiting

  • Miami Cancer Institute at Baptist Health (Kendall)

    Miami, Florida, 33176

    Lauren Carcas, MD, laurencar@baptisthealth.net

    Lauren Carcas, MD

    Recruiting

  • DFCI @ Milford Regional Hospital

    Milford, Massachusetts, 01757

    Natalie Sinclair, MD, nsinclair1@partners.org

    Natalie Sinclair, MD

    Recruiting

  • University of Pennsylvania-Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Payal Shah, MD, payal.shah@pennmedicine.upenn.edu

    Payal Shah, MD

    Recruiting

  • Miami Cancer Institute at Baptist Health

    Plantation, Florida, 33324

    Lauren Carcas, MD, laurencar@baptisthealth.net

    Lauren Carcas, MD

    Recruiting

  • DF/BWCC in Clinical Affiliation with South Shore Hospital

    South Weymouth, Massachusetts, 02190

    Thomas P O'Connor, MD, ThomasP_O'Connor@DFCI.HARVARD.EDU

    Thomas P O'Connor, MD

    Recruiting

  • Stamford Hospital

    Stamford, Connecticut, 06904

    K.M. Steve Lo, MD, slo@stamhealth.org

    K.M. Steve Lo, MD

    Recruiting

Other trials in United States

About this study

Official title: Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)

This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative.

The names of the study interventions involved in this study are:

  • Sacituzumab govitecan (Trodelvy™;IMMU-132)
  • Pembrolizumab (Keytruda®; MK-3475)
Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or a combination of investigational drugs to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug or drug combination is being studied.

The U.S. Food and Drug Administration (FDA) has approved Sacituzumab Govitecan for metastatic triple-negative breast cancer, but it is currently approved only for patients who have had 2 or more prior regimens for metastatic disease. The U.S. Food and Drug Administration (FDA) has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is currently approved only for patients with PD-L1-positive metastatic triple-negative breast cancer.

In this research study, we are:

  • Studying Sacituzumab Govitecan alone or in combination with Pembrolizumab as a possible treatment for patients with metastatic triple-negative breast cancers that are PD-L1-negative.
  • Sacituzumab Govitecan is composed of a chemotherapy drug, called Irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. The antibody in this study binds to certain types of cancer tumors, including triple-negative breast tumors.
  • Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body's own immune system to seek out and destroy tumors. It has been used in previous research studies to treat breast cancer, where it has been shown to be effective.
  • The overall goal of this study is to evaluate the effectiveness of either Sacituzumab Govitecan alone or in combination with Pembrolizumab, in delaying the worsening of triple-negative breast cancers that are PD-L1-negative.

The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, questionnaires, data collection, and study treatment including evaluations and follow up visits.

Participants will be randomized into one of two groups.

  • Group A: Sacituzumab Govitecan on days 1 and 8 and Pembrolizumab on day 1 of a 21-day cycle
  • Group B: Sacituzumab Govitecan alone on days 1 and 8 of a 21-day cycle

Participants will receive study treatment for as long as they are benefitting from this therapy. Participants will be followed for the rest of their life.

It is expected that about 110 people will take part in this research study.

Being tested
Sacituzumab Govitecan, Pembrolizumab
Keywords
Breast Cancer, Triple Negative Breast Cancer, PD-L1 Negative
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab GovitecanDrug

    Also called IMMU-132, Trodelvy

    Intravenous Infusion

  • PembrolizumabDrug

    Also called Keytruda

    Intravenous Infusion

Study groups in NCT04468061
Study groupRoleWhat they receive
Sacituzumab Govitecan + PembrolizumabExperimentalParticipants will receive Sacituzumab Govitecan + Pembrolizumab at a pre-determined dose during a 21 day cycle. Sacituzumab Govitecan will be given on days 1 and 8 of the 21 day cycle Pembrolizumab will be given on day 1 of the 21 day cycle.
Receives: Drug: Sacituzumab Govitecan; Drug: Pembrolizumab
Sacituzumab GovitecanExperimentalParticipants will receive Sacituzumab Govitecan at a pre-determined dose during a 21 day cycle. Sacituzumab Govitecan will be given on days 1 and 8 of a 21-day cycle
Receives: Drug: Sacituzumab Govitecan
RetreatmentExperimentalParticipants randomized to the combination arm (Sacituzumab Govitecan + Pembrolizumab) who stop with CR after at least 24 weeks of treatment may be eligible for additional pembrolizumab and/or sacituzumab govitecan therapy if they progress after stopping study treatment. This is termed the Second Course Phase and is only available if the study remains open and the subject meets conditions. .
Receives: Drug: Sacituzumab Govitecan; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Compare PFS of patients randomized to receive sacituzumab govitecan in combination with pembrolizumab (Arm A) versus those randomized to receive sacituzumab govitecan monotherapy (Arm B).

    Defined as the time from study randomization to disease progression, per RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first.

    Measured: 3 years

Secondary outcomes (7)

  1. Overall Survival (OS)

    Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Overall Survival (OS), defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive, will be reported with Kaplan Meier estimates.

    Measured: 3 years

  2. Objective Response Rate (ORR)

    Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Objective Response Rate by RECIST 1.1.

    Measured: 3 years

  3. Duration of response (DOR)

    Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the duration of response (the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death due to any cause. Participants without events reported are censored at the last disease evaluation).

    Measured: 3 years

  4. Time to objective response (TTOR)

    Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the time to objective response defined as the time from randomization to the date of the first documented CR or PR (whichever is first recorded).

    Measured: 3 years

  5. Time to progression (TTP)

    Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Time to progression (TTP) defined as the time from randomization (or registration) to progression, or censored at date of last disease evaluation for those without progression reported.

    Measured: 3 years

  6. Clinical benefit rate (CBR)

    Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Clinical benefit rate (CBR) according to RECIST 1.1, defined as CR, PR or stable disease for ≥ 24 weeks.

    Measured: 3 years

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

    Evaluate the safety and tolerability of sacituzumab govitecan and pembrolizumab compared to sacituzumab govitecan alone by monitoring adverse events, including immune-related adverse events.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start20 Jul 2020
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468061
Sponsor's protocol ID
20-166
Status last verified
Apr 2026
First submitted
8 Jul 2020
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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: \[contact information for Sponsor Investigator or designee\]. 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.

Publications

  • Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.

    PubMed 35728046

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan and Pembrolizumab in people with Breast Cancer and Triple Negative Breast Cancer, run by Dana-Farber Cancer Institute at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ana C Garrido-Castro, MD (617-632-6409, Ana_Garrido-Castro@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04468061, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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