Breast CancerPhase 2NCT05675579
A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
A Phase 2 study testing Sacituzumab Govitecan and Pembrolizumab in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if sacituzumab govitecan and pembrolizumab, when given before surgery, can help to control early-stage triple negative breast cancer that has not responded well to other treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- 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
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 31 Dec 2026
- 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
- Female or male patients 18 years of age or older.
- Histologically or cytologically confirmed breast cancer
- T1c N1-2 or T2-4 N0-2 early-stage disease
- ER/PR negative (ER/PR <1%) or ER/PR low positive (1%≤ER/PR≤10%), and HER2 negative as per institutional and ASCO-CAP guidelines)
- Initiated the NAC with the first regimen of KN-522 regimen (i.e., pembrolizumab 200 mg Q3W, given with 4 cycles of paclitaxel + carboplatin).
- ECOG performance score of 0 or 1.
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- The volumetric change of primary tumor = 0% or increase in volumetric size by US or MRI after completing the first part of the KN-522 regimen.
- Negative serum pregnancy test within 72 hours of receiving the first dose of the study medication for women of childbearing potential as per institutional guidelines. Postmenopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy tests.
- Agreed with undergoing the image-guided core needle biopsy after completing the first part of neoadjuvant treatment regimen.
- Subjects of childbearing potential should be willing to use effective birth control methods or be surgically sterile or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of the study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Effective methods of birth control include:
- Use hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin).
- Intrauterine devices (IUDs).
- Using 2 barrier methods (each partner must use 1 barrier method) with a spermicide. Males must use the male condom (latex or other synthetic material) with spermicide. Females must choose either a Diaphragm with spermicide, cervical cap with spermicide, or a sponge.
- The patient must have adequate organ function as determined by the following laboratory values:
- Absolute neutrophil count* ≥ 1,500 /μL
- Platelets* ≥ 100,000 /μL
- Hemoglobin* ≥ 9 g/dL
- Creatinine clearance > 50 ml/min
- Total bilirubin ≤ 1.5 X ULN
- Alanine aminotransferase and aspartate aminotransferase < 2.5 X ULN *Hematologic counts above should be without transfusion or growth factor support within 2 weeks of study drug initiation.
Who cannot join
- Stage IV disease
- Any other previous antitumor therapies for the current cancer event.
- Pregnant or planning to become pregnant during therapy.
- Gastrointestinal tract disease or defect or previous history of colitis.
- Has an active autoimmune disease that requires systemic therapy within two years of treatment or a medical condition that requires immunosuppression.
- Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
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- Has known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection (screen test is not required). Subjects positive for hepatitis C (HCV) antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
- Has a cognitive impairment.
- Any other major comorbidities that can impact receiving immunotherapy or Sacituzumab govitecan.
- Have live vaccinations within 30 days prior to registration and receive study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if sacituzumab govitecan and pembrolizumab, when given before surgery, can help to control early-stage triple negative breast cancer that has not responded well to other treatments.
Read the detailed description
Primary Objective:
- To determine the efficacy of sacituzumab govitecan and pembrolizumab combination treatment on pathological complete response (pCR)/residual cancer burden (RCB)-1 in the patients with early-stage TNBC who showed a resistance to the combination of immunochemotherapy.
Secondary Objectives:
- To determine the safety of the proposed combination treatment.
- To determine the objective overall response rate (ORR) of the proposed treatment.
- To determine the distant-recurrence-free survival (DRFS).
- To determine the 3-year event-free survival (EFS) rate.
- To determine the 3-year overall survival (OS) rate.
Exploratory Objective:
- To investigate the response biomarkers in the tumor tissues and peripheral blood.
- Conditions
- Breast Cancer
- Being tested
- Sacituzumab Govitecan, Pembrolizumab
- Medical subject headings
- 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) Immunomedics
Given by IV (vein)
PembrolizumabDrug
Also called KEYTRUDA®
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan and Pembrolizumab | Experimental | Participants will receive drug on Days 1 and 8 of Cycles 1-4, Participants will receive sacituzumab govitecan by vein.
Participants will receive drug on Days 1, 8, and 15 of each cycle, Participants will receive pembrolizumab by vein. Receives: Drug: Sacituzumab Govitecan; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start23 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Clinton Yam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675579
- Sponsor's protocol ID
- 2022-0431
- Other IDs
- NCI-2022-10926
- Status last verified
- May 2026
- First submitted
- 22 Dec 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT05675579
- Acronym / sponsor ID
- 2022-0431
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if sacituzumab govitecan and pembrolizumab, when given before surgery, can help to control early-stage triple negative breast cancer that has not responded well to other treatments.
Detailed description
Primary Objective:
- To determine the efficacy of sacituzumab govitecan and pembrolizumab combination treatment on pathological complete response (pCR)/residual cancer burden (RCB)-1 in the patients with early-stage TNBC who showed a resistance to the combination of immunochemotherapy.
Secondary Objectives:
- To determine the safety of the proposed combination treatment.
- To determine the objective overall response rate (ORR) of the proposed treatment.
- To determine the distant-recurrence-free survival (DRFS).
- To determine the 3-year event-free survival (EFS) rate.
- To determine the 3-year overall survival (OS) rate.
Exploratory Objective:
- To investigate the response biomarkers in the tumor tissues and peripheral blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan and Pembrolizumab | Experimental | Drug: Sacituzumab Govitecan, Drug: PembrolizumabParticipants will receive drug on Days 1 and 8 of Cycles 1-4, Participants will receive sacituzumab govitecan by vein. Participants will receive drug on Days 1, 8, and 15 of each cycle, Participants will receive pembrolizumab by vein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Female or male patients 18 years of age or older.
- Histologically or cytologically confirmed breast cancer
- T1c N1-2 or T2-4 N0-2 early-stage disease
- ER/PR negative (ER/PR <1%) or ER/PR low positive (1%≤ER/PR≤10%), and HER2 negative as per institutional and ASCO-CAP guidelines)
- Initiated the NAC with the first regimen of KN-522 regimen (i.e., pembrolizumab 200 mg Q3W, given with 4 cycles of paclitaxel + carboplatin).
Key exclusion criteria (10 listed)
- Stage IV disease
- Any other previous antitumor therapies for the current cancer event.
- Pregnant or planning to become pregnant during therapy.
- Gastrointestinal tract disease or defect or previous history of colitis.
- Has an active autoimmune disease that requires systemic therapy within two years of treatment or a medical condition that requires immunosuppression.
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 |
|---|---|---|
| Sacituzumab GovitecanAlso: (IMMU-132) ImmunomedicsGiven by IV (vein) | Drug | Sacituzumab Govitecan and Pembrolizumab |
| PembrolizumabAlso: KEYTRUDA®Given by IV (vein) | Drug | Sacituzumab Govitecan and Pembrolizumab |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Clinton Yam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan and Pembrolizumab in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site 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 20 inclusion and 10 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year.). 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 20 May 2026.