TNBC - Triple-Negative Breast CancerPhase 2NCT07015853
ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation
A Phase 2 study testing Pembrolizumab, Radiotherapy and Axatilimab in people with TNBC - Triple-Negative Breast Cancer and Breast Cancer, run by Stephen Shiao at 1 site in United States.
Trial summary
Open label, single-arm, prospective therapeutic trial. Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer, Breast Cancer
- What is being tested?
- Pembrolizumab, Radiotherapy and Axatilimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jul 2033
- 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
- Age ≥ 18 years at the time of consent.
- Patients with metastatic or locally recurrent TNBC who received prior immunotherapy in any setting (curative or advanced/metastatic).
- Have ≥2 measurable, non-osseous, non-hepatic recurrent or metastatic lesions. Of these lesions, at least one is indicated for radiation therapy and at least one will not be irradiated to be used to determine response. Notes on lesions: patients are still eligible if they have liver or bone lesions, so long as at least 2 measurable lesions are non-osseous, non-hepatic recurrent or metastatic per above criterion.
- Histologically or cytologically-confirmed TNBC, defined as ER <10%, PR <10%, HER2-negative by ASCO CAP guidelines. Note: HER2 0-2+ IHC is allowed (i.e., if FISH-negative, this is still considered HER2-negative).
- ECOG Performance Status ≤ 1.
- Demonstrate adequate organ function
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- Female subject of childbearing potential should have a negative serum or urine pregnancy test or documentation of absence of pregnancy by a gynecologist within 14 days of initiating first dose of pembrolizumab for eligibility verification.
- Female subjects of childbearing potential should be willing to use highly effective contraceptive methods (Appendix 12.6) during the treatment period through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male participants should be willing to use highly effective contraceptive methods (Appendix 12.6) during the treatment period through 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
- Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has had prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study treatment Day 1 or who has not recovered (i.e., > Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier.
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- Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., > Grade 1 or baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Has a known additional malignancy that is progressing or has required treatment within the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least four weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.).
- Has known history of/active, non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/active interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. Note: Negative urine or serum pregnancy test is also conducted within 72 hours prior to C1D1 for study procedures but if screening pregnancy test is done within 72 hours of C1D1, it is not required to be repeated.
- Has a known history of Human Immunodeficiency Virus (HIV). HIV testing is not required unless mandated by local health authority.
- History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA [qualitative]) infection. Note: Testing for Hepatitis B or C is not required unless mandated by local health authority.
- Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of pembrolizumab. Administration of killed vaccines is allowed.
- Has had an allogeneic tissue/solid organ transplant, including patients with prior allogeneic hematopoietic stem-cell transplant.
- Patients eligible for PARP inhibitor therapy.
- Any patient with prior immune-related treatment toxicity for which permanent discontinuation is indicated.
- History of acute or chronic pancreatitis. Note: Participants who had a defined pancreatitis etiology (e.g., pancreatitis due to gallstones, trauma/injury, or medications such as asparaginase) may be enrolled if pancreatitis resolved prior to study enrollment.
- History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study enrollment.
- Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to study enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: IIT2024-02-SHIAO-ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation
Open label, single-arm, prospective therapeutic trial. Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. RT, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance.
Read the detailed description
Checkpoint blockade-mediated immunotherapy (IO) is an emerging cornerstone in the treatment of triple negative breast cancer (TNBC) in both the metastatic and curative intent settings. Initial studies of IO monotherapy in heavily pretreated metastatic TNBC were disappointing with low objective response rate (ORR) (5.3%: KEYNOTE-086, KEYNOTE-119) and no effect in OS (1-3). However, recent studies in patients with previously untreated metastatic TNBC, showed IO combinations with chemotherapy were associated with improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone in patients with "PD-L1 positive" disease (IMpassion130 and KEYNOTE-355) (4-7). Nonetheless, nearly half of patients on IMpassion130 had grade 3 or higher toxicity, leading to a discontinuation rate of 16.9%, and over 70% of all patients on first-line IO containing regimens will experience disease progression within one year. Based on these data, IO-containing regimens have become the standard-of-care treatment option for metastatic TNBC, albeit with a high failure rate and a non-trivial toxicity profile. Second line antibody-drug conjugate Sacituzumab govitecan while also improving response in metastatic TNBC still has 85% of patients fail at 1 year (ASCENT, Bardia NEJM 2021). Therefore, novel strategies that augment IO-enhanced tumor-specific responses and limit treatment-associated toxicities are critically important in TNBC. Lastly, radiotherapy (RT), commonly used in palliation of metastatic TNBC, is a potent modulator of the immune response, and can produce responses in unirradiated tumors in combination with IO (8-11).
- Being tested
- Pembrolizumab, Radiotherapy, Axatilimab
- Keywords
- Pembrolizumab, Axatilimab, CSF-1R inhibitor, potent humanized immunoglobulin G4 (IgG4), Radiation Therapy
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Ketruda
Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance.
RadiotherapyRadiation
RT, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2;
AxatilimabDrug
Also called CSF-1R inhibitor
Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab, Radiotherapy, Axatilimab | Experimental | Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance.
Radiotherapy, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance. Receives: Drug: Pembrolizumab; Radiation: Radiotherapy; Drug: Axatilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The proportion of patients with confirmed PR or CR per RECIST v1.1, assessed from the start of study treatment (defined as from first dose of pembrolizumab) for up to two years. ORR in the non-targeted, unirradiated lesion(s) as defined by CR or PR per iRECIST. Objective response will be assessed separately in all sites that are not irradiated.
Measured: From start of study treatment until subject proceeds to standard of care treatment, up to 2 years.
Secondary outcomes (4)
Number of Adverse Events Related to Study Treatment
To determine the safety, toxicity, and tolerability of the combination in recurrent or metastatic TNBC. Safety, toxicity, and tolerability of the combination will be assessed by the number of adverse events related to study treatment per NCI's CTCAE v5.0 from start of study treatment up to 90 days post end of study treatment.
Measured: From start of study treatment up to 90 days post end of study treatment.
Progression-free survival (PFS)
To assess progression-free survival (PFS). Assessed from the start of study treatment until documented progression, or death due to any cause.
Measured: Up to 2 years post end of study treatment.
Overall Survival (OS)
To assess overall survival (OS). Assessed from the start of study treatment until death due to any cause.
Measured: Up to 2 years post end of study treatment.
Duration of Response (DoR)
To assess duration of response (DoR). Assessed from the start of study treatment until documented progression, or death due to any cause.
Measured: Up to 2 years post end of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study startJun 2026 (estimated)
- Primary completionJul 2033 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single-arm, prospective therapeautic trial
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephen Shiao
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Incyte Corporation
- Responsible party
- Sponsor-investigator, Stephen Shiao, Cedars-Sinai Medical Center
- Investigators
- Stephen Shiao, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015853
- Sponsor's protocol ID
- IIT2024-02-SHIAO-ASTRAEA
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2024-02-SHIAO-ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation
- ClinicalTrials.gov ID
- NCT07015853
- Acronym / sponsor ID
- IIT2024-02-SHIAO-ASTRAEA
- Keywords
- Pembrolizumab, Axatilimab, CSF-1R inhibitor, potent humanized immunoglobulin G4 (IgG4), Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Stephen ShiaoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Incyte Corporation
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 11 Jun 2025 (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.
Open label, single-arm, prospective therapeutic trial. Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. RT, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance.
Detailed description
Checkpoint blockade-mediated immunotherapy (IO) is an emerging cornerstone in the treatment of triple negative breast cancer (TNBC) in both the metastatic and curative intent settings. Initial studies of IO monotherapy in heavily pretreated metastatic TNBC were disappointing with low objective response rate (ORR) (5.3%: KEYNOTE-086, KEYNOTE-119) and no effect in OS (1-3). However, recent studies in patients with previously untreated metastatic TNBC, showed IO combinations with chemotherapy were associated with improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone in patients with "PD-L1 positive" disease (IMpassion130 and KEYNOTE-355) (4-7). Nonetheless, nearly half of patients on IMpassion130 had grade 3 or higher toxicity, leading to a discontinuation rate of 16.9%, and over 70% of all patients on first-line IO containing regimens will experience disease progression within one year. Based on these data, IO-containing regimens have become the standard-of-care treatment option for metastatic TNBC, albeit with a high failure rate and a non-trivial toxicity profile. Second line antibody-drug conjugate Sacituzumab govitecan while also improving response in metastatic TNBC still has 85% of patients fail at 1 year (ASCENT, Bardia NEJM 2021). Therefore, novel strategies that augment IO-enhanced tumor-specific responses and limit treatment-associated toxicities are critically important in TNBC. Lastly, radiotherapy (RT), commonly used in palliation of metastatic TNBC, is a potent modulator of the immune response, and can produce responses in unirradiated tumors in combination with IO (8-11).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single-arm, prospective therapeautic trial
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab, Radiotherapy, Axatilimab | Experimental | Drug: Pembrolizumab, Radiation: Radiotherapy, Drug: AxatilimabPembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. Radiotherapy, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years at the time of consent.
- Patients with metastatic or locally recurrent TNBC who received prior immunotherapy in any setting (curative or advanced/metastatic).
- Have ≥2 measurable, non-osseous, non-hepatic recurrent or metastatic lesions. Of these lesions, at least one is indicated for radiation therapy and at least one will not be irradiated to be used to determine response. Notes on lesions: patients are still eligible if they have liver or bone lesions, so long as at least 2 measurable lesions are non-osseous, non-hepatic recurrent or metastatic per above criterion.
- Histologically or cytologically-confirmed TNBC, defined as ER <10%, PR <10%, HER2-negative by ASCO CAP guidelines. Note: HER2 0-2+ IHC is allowed (i.e., if FISH-negative, this is still considered HER2-negative).
- ECOG Performance Status ≤ 1.
Key exclusion criteria (24 listed)
- Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
- Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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: KetrudaPembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. | Drug | Pembrolizumab, Radiotherapy, Axatilimab |
| RadiotherapyRT, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; | Radiation | Pembrolizumab, Radiotherapy, Axatilimab |
| AxatilimabAlso: CSF-1R inhibitorAxatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance. | Drug | Pembrolizumab, Radiotherapy, Axatilimab |
Primary outcome
Overall Response Rate (ORR)
Time frame: From start of study treatment until subject proceeds to standard of care treatment, up to 2 years.
The proportion of patients with confirmed PR or CR per RECIST v1.1, assessed from the start of study treatment (defined as from first dose of pembrolizumab) for up to two years. ORR in the non-targeted, unirradiated lesion(s) as defined by CR or PR per iRECIST. Objective response will be assessed separately in all sites that are not irradiated.
4 secondary outcomes
Number of Adverse Events Related to Study Treatment
Time frame: From start of study treatment up to 90 days post end of study treatment.
Progression-free survival (PFS)
Time frame: Up to 2 years post end of study treatment.
Overall Survival (OS)
Time frame: Up to 2 years post end of study treatment.
Duration of Response (DoR)
Time frame: Up to 2 years post end of study treatment.
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 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Stephen Shiao, MD principal investigator
Cedars-Sinai Medical 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 Pembrolizumab, Radiotherapy and Axatilimab in people with TNBC - Triple-Negative Breast Cancer and Breast Cancer, run by Stephen Shiao 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 10 inclusion and 24 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: opening soon, as of the sponsor's last update on 20 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 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?
Contact Clinical Trial Navigator (3104232133, cancer.trial.info@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From start of study treatment until subject proceeds to standard of care treatment, up to 2 years.). 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 Apr 2026.