Invasive Breast CancerPhase 2NCT04448886
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
A Phase 2 study testing Pembrolizumab and Sacituzumab Govitecan in people with Invasive Breast Cancer and Metastatic Breast Cancer, run by Ana C Garrido-Castro, MD at 8 sites in United States.
Trial summary
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: Sacituzumab govitecan (IMMU-132) Pembrolizumab (Keytruda®; MK-3475) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer
- What is being tested?
- Pembrolizumab and Sacituzumab Govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Sep 2020to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, i.e. visible chest wall disease or metastases on imaging meeting standard radiology criteria (i.e. lymph nodes larger than 1 cm in the short axis diameter).
- Participants must have HR-positive, HER2-negative breast cancer (ER>1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines) on local pathology review. If a patient has more than one histological result, the most recent sample will be considered for inclusion.
- Participants must have either progressed on or within 12 months of adjuvant endocrine therapy or have progressed on at least one line of endocrine therapy for metastatic disease, and be considered appropriate candidates for chemotherapy.
- Participants must have evaluable or measurable disease per RECIST 1.1. For instance, 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. Participants must agree to a mandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely accessible.
- Prior chemotherapy: Participants may have received 0-1 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to study treatment initiation. If a prior chemotherapy was given for less than 1 cycle, it will not be counted as a prior line. 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, except alopecia can be any grade and neuropathy can be grade 2 or lower.
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- Prior biologic therapy: Patients must have discontinued all biologic therapy at least 14 days prior to study treatment initiation. All toxicities related to prior biologic therapy must have resolved to CTCAE v5.0 grade 1 or lower.
- Prior targeted therapy: Targeted therapy must have been discontinued ≥ 14 days prior to initiation of study therapy. All toxicities related to prior targeted therapy must have resolved to CTCAE v5.0 grade 1 or lower.
- Prior radiation therapy: Patients may have received prior radiation therapy. Radiation therapy must be completed at least 7 days prior to the initiation of study treatment (at least 7 days for SRS), 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.
- 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 subject is ≥ 18 years old.
- ECOG performance status 0-1 (Karnofsky > 60%).
- 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, and copper intrauterine devices. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Hormonal contraceptives are contraindicated for HR+ breast cancer.
- 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.
- The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.
Who cannot join
- Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan. Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic disease.
- Prior hypersensitivity to the excipients of pembrolizumab or sacituzumab govitecan 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/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
- 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. 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago Medical Center
Chicago, Illinois, 60637
DFCI @ Foxborough
Foxborough, Massachusetts, 02035
DFCI @ Milford Regional Hospital
Milford, Massachusetts, 01757
University of Pennsylvania-Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
DF/BWCC in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190
About this study
Official title: Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC)
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer.
The names of the study interventions involved in this study are:
- Sacituzumab govitecan (IMMU-132)
- Pembrolizumab (Keytruda®; MK-3475)
Read the detailed description
The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits.
The names of the study interventions involved in this study are:
- Sacituzumab govitecan (IMMU-132)
- Pembrolizumab (Keytruda®; MK-3475)
- Questionnaires/Data Collection/Sample Collection
Participants will be randomized into one of two groups. Group A: Sacituzumab govitecan (IMMU-132) and Pembrolizumab Group B: Sacituzumab govitecan (IMMU-132)
Participants will receive study treatment for as long they are benefiting from the therapy. Participants will be followed for the rest of their lives. It is expected that about 110 people will take part in this research study
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 not approved Sacituzumab Govitecan for your specific disease, but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab for your specific disease but it has been approved for other uses.
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Being tested
- Pembrolizumab, Sacituzumab Govitecan
- Keywords
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
(iv) fixed dose, administered once per cycle
Sacituzumab GovitecanDrug
Also called TRODELVY
(iv) fixed dose, administered twice per cycle
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan + Pembrolizumab | Experimental | The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days
* Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
* Pembrolizumab (iv) fixed dose administered once per cycle Receives: Drug: Pembrolizumab; Drug: Sacituzumab Govitecan |
| Sacituzumab Govitecan | Experimental | The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits.
- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle Receives: Drug: Sacituzumab Govitecan |
| Retreatment | Experimental | Participants who have attained a confirmed complete response (CR) who have been treated for at least 24 weeks on protocol therapy and had at least three cycles (with pembrolizumab and sacituzumab govitecan (Arm A) or sacituzumab govitecan alone (Arm B)) beyond the date when the initial CR was declared may be eligible for additional sacituzumab govitecan and/or pembrolizumab therapy if they progress after stopping study treatment. This retreatment is termed the Second Course Phase of this study and is only available if the study remains open and the subject meets protocol-specified conditions. Receives: Drug: Pembrolizumab; Drug: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone. PFS is defined as the time from study randomization to disease progression, according to 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. Patients alive without disease progression are censored at the date of last disease evaluation.
Measured: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024.
Secondary outcomes (5)
Objective Response Rate
Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Overall Response Rate (ORR) by RECIST 1.1
Measured: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Overall Survival
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 with censoring at date last known alive, will be reported with Kaplan Meier estimates
Measured: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Clinical Benefit Rate
Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing clinical benefit rate (CBR). CBR defined as CR, PR or stable disease for ≥ 24 weeks according to RECIST 1.1
Measured: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Time to Progression
Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing time to progression
Measured: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Duration of Response
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)
Measured: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start23 Sep 2020
- Primary completion9 Mar 2024
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (actual)
Sponsor and investigators
- Lead sponsor
- Ana C Garrido-Castro, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Gilead Sciences
- Responsible party
- Sponsor-investigator, Ana C Garrido-Castro, MD, Dana-Farber Cancer Institute
- Investigators
- Ana Garrido-Castro, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448886
- Sponsor's protocol ID
- 20-153
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2020
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT04448886
- Acronym / sponsor ID
- 20-153
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Keywords
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ana C Garrido-Castro, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Gilead Sciences
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 9 Mar 2024 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Jun 2020 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer.
The names of the study interventions involved in this study are:
- Sacituzumab govitecan (IMMU-132)
- Pembrolizumab (Keytruda®; MK-3475)
Detailed description
The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits.
The names of the study interventions involved in this study are:
- Sacituzumab govitecan (IMMU-132)
- Pembrolizumab (Keytruda®; MK-3475)
- Questionnaires/Data Collection/Sample Collection
Participants will be randomized into one of two groups. Group A: Sacituzumab govitecan (IMMU-132) and Pembrolizumab Group B: Sacituzumab govitecan (IMMU-132)
Participants will receive study treatment for as long they are benefiting from the therapy. Participants will be followed for the rest of their lives. It is expected that about 110 people will take part in this research study
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 not approved Sacituzumab Govitecan for your specific disease, but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab for your specific disease but it has been approved for other uses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan + Pembrolizumab | Experimental | Drug: Pembrolizumab, Drug: Sacituzumab GovitecanThe research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle |
| Sacituzumab Govitecan | Experimental | Drug: Sacituzumab GovitecanThe research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. - Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle |
| Retreatment | Experimental | Drug: Pembrolizumab, Drug: Sacituzumab GovitecanParticipants who have attained a confirmed complete response (CR) who have been treated for at least 24 weeks on protocol therapy and had at least three cycles (with pembrolizumab and sacituzumab govitecan (Arm A) or sacituzumab govitecan alone (Arm B)) beyond the date when the initial CR was declared may be eligible for additional sacituzumab govitecan and/or pembrolizumab therapy if they progress after stopping study treatment. This retreatment is termed the Second Course Phase of this study and is only available if the study remains open and the subject meets protocol-specified conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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, i.e. visible chest wall disease or metastases on imaging meeting standard radiology criteria (i.e. lymph nodes larger than 1 cm in the short axis diameter).
- Participants must have HR-positive, HER2-negative breast cancer (ER>1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines) on local pathology review. If a patient has more than one histological result, the most recent sample will be considered for inclusion.
- Participants must have either progressed on or within 12 months of adjuvant endocrine therapy or have progressed on at least one line of endocrine therapy for metastatic disease, and be considered appropriate candidates for chemotherapy.
- Participants must have evaluable or measurable disease per RECIST 1.1. For instance, 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. Participants must agree to a mandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely accessible.
Key exclusion criteria (15 listed)
- Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan. Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic disease.
- Prior hypersensitivity to the excipients of pembrolizumab or sacituzumab govitecan 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: Keytruda(iv) fixed dose, administered once per cycle | Drug | Retreatment, Sacituzumab Govitecan + Pembrolizumab |
| Sacituzumab GovitecanAlso: TRODELVY(iv) fixed dose, administered twice per cycle | Drug | Retreatment, Sacituzumab Govitecan, Sacituzumab Govitecan + Pembrolizumab |
Primary outcome
Progression Free Survival
Time frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024.
Compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone. PFS is defined as the time from study randomization to disease progression, according to 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. Patients alive without disease progression are censored at the date of last disease evaluation.
5 secondary outcomes
Objective Response Rate
Time frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Overall Survival
Time frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Clinical Benefit Rate
Time frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Time to Progression
Time frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Duration of Response
Time frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Garrido-Castro, MD principal investigator
Dana-Farber Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Sacituzumab Govitecan in people with Invasive Breast Cancer and Metastatic Breast Cancer, run by Ana C Garrido-Castro, MD at 8 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.