Breast CancerPhase 2NCT05570253
A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer
A Phase 2 study testing Eribulin and SDX-7320 in people with Breast Cancer and Metastatic Triple-Negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.
Trial summary
The researchers are doing this study to find out whether the study drug, SDX-7320, when combined with the standard chemotherapy eribulin, is an effective treatment for people with TNBC and metabolic dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Triple-Negative Breast Cancer
- What is being tested?
- Eribulin and SDX-7320
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Oct 2022to Oct 2027
- 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
- Male or female with histologically and/or cytologically confirmed diagnosis of triple-negative metastatic breast cancer defined as estrogen and progesterone receptor staining ≤10%; and HER2-negative defined as IHC 0 to 1+ at enrolling institution (note: if IHC is equivocal, non-amplified status by FISH is acceptable)
- Advanced (local regionally recurrent, not amenable to curative therapy or surgery) or metastatic stage with up to 2 prior lines of therapy in the advanced or metastatic setting
- Received prior anthracycline and taxane chemotherapy in the neoadjuvant, adjuvant, or metastatic settings and considered appropriate for treatment with single agent eribulin OR was otherwise ineligible to receive anthracycline and/or taxane per treating physician OR patients with de novo metastatic disease.
- Evidence of metabolic dysfunction defined as HbA1c > 5.5 and/or BMI ≥ 30 kg/m^2
- Measurable disease per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), OR at least one evaluable, predominantly lytic bone lesion
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1.
Show all 27Show fewer
- Adult ≥18 at the time of informed consent and has provided written informed consent before the performance of any study-related activities and according to local guidelines.
- Adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory for eligibility):
- Absolute neutrophil count (ANC) ≥ 1,000 µL
- Platelet count ≥ 140,000 µL
- Hemoglobin ≥9.0 g/dL:
- Calcium (corrected for serum albumin) and magnesium ≤ Grade 1 according to National Cancer Institute (NCI) Common Terminology
- Calculate Corrected Calcium if the albumin and/or serum calcium are not within normal limits: Corrected Calcium= Serum Calcium + 0.8 x [(Normal Albumin) - Patient Albumin] Normal Albumin value = 4.4g/dL Criteria for Adverse Events (CTCAE), version 5.0, and not considered by the Investigator to be clinically significant
- Potassium within normal limits, with or without correction with supplements.
- In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×the upper limit of normal (ULN). If the patient has liver metastases, ALT and AST ≤5×ULN.
- Total bilirubin ≤1.5×ULN except for patient with Gilbert's syndrome who may only be included if the total bilirubin is ≤3.0×ULN or direct bilirubin ≤1.5×ULN
- Creatinine ≤1.5 mg/dL.
- Patient is, in the treating Investigator's opinion, willing and able to comply with the study requirements, including the ability to fast prior to treatment days.
- If sexually active female of childbearing potential, willing to use a contraception method listed below:
- Oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception
- Oral, injectable, or implantable progesterone-only hormonal contraception
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner with documentation of successful vasectomy.
- Complete abstinence from heterosexual intercourse
- If a sexually active male, willing to use barrier contraception (condoms)
Who cannot join
- Three or greater prior lines of therapy for metastatic TNBC
- Known primary brain malignancy, brain metastases or active CNS pathology, any of which as determined by the treating Investigator
- Currently participating in a study of an investigational agent
- Body mass index < 18.5 kg/m2
- Known hypersensitivity to SDX-7320 or eribulin
- Established diagnosis of diabetes mellitus type I or uncontrolled or insulin-dependent type II. Uncontrolled is defined as fasting blood glucose >140 mg/dL and/or HbA1c ≥8%
Show all 27Show fewer
- Use of combination antihyperglycemic therapy (single agent metformin on stable dose for at least 3 months prior to enrollment is allowable)
- Concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous skin cancer or curatively resected cervical cancer.
- Uncontrolled human immunodeficiency virus (HIV) infection. (Testing is not mandatory.)
- Evidence of uncontrolled active Hepatitis B or C infection
- History of Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), or other severe medication-related cutaneous reactions.
- Any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (e.g., chronic active hepatitis, severe hepatic impairment).
- Clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following:
- History of angina pectoris, coronary artery bypass graft (CABG) symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.
- History of documented congestive heart failure (New York Heart Association functional classification III-IV).
- Documented cardiomyopathy.
- Left ventricular ejection fraction (LVEF) <45%, as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).
- History of any cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle block, high grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
- Uncontrolled hypertension, defined by a systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: risk factors for torsades de pointe including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia; concomitant medications with a known risk to prolong the QT interval and known to cause torsades de pointe that cannot be discontinued or replaced by safe alternative medications.
- Bradycardia (heart rate less than 50 at rest), by electrocardiogram (ECG) or pulse.
- Inability to determine the QT interval on the ECG (i.e., unreadable or not interpretable) or corrected QT (QTcF) >450 msec for males and >470 msec for females (using Fridericia's correction) during Screening, based on the mean of triplicate ECGs
- Currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment: Medications with a known risk to prolong the QT interval or induce Torsade de Pointes (TdP). CredibleMeds list of drugs known to cause TdP may be used as a reference for this study to determine which drugs are prohibited using the following link: https://crediblemeds.org/new-drug-list or a crediblemeds mobile application.
- °Herbal preparations/medications, with the exception of cannabinoids, CBD compounds, etc.
- Participation in a prior investigational study within 14 days prior to the start of the study treatment or within 5 half-lives of study drug, whichever is longer.
- History of acute pancreatitis within 1 year of Screening or past medical history of chronic pancreatitis
- Pregnant patients
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tiffany Trainia, MD contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Emory University (Data Collection Only)
Atlanta, Georgia, 30322
Neil Iyengar, MD, 404-778-1900
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Sherry Shen, MD, 646-888-5134
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725
Sherry Shen, MD, 646-888-5134
- Recruiting
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Deena Graham, MD, 551-996-5811
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Sherry Shen, MD, 646-888-5134
- Recruiting
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, 33143
Lauren Carcas, MD, 954-837-1490
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Sherry Shen, MD, 646-888-5134
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Sherry Shen, MD, 646-888-5134
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Sherry Shen, MD, 646-888-5134
Tiffany Traina, MD, 646-888-4558
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Sherry Shen, MD, 646-888-5134
About this study
Official title: "A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study
The researchers are doing this study to find out whether the study drug, SDX-7320, when combined with the standard chemotherapy eribulin, is an effective treatment for people with TNBC and metabolic dysfunction. The researchers will also look at whether the study treatment (SDX-7320 combined with eribulin) is safe and causes few or mild side effects in participants. The researchers will compare this treatment approach to eribulin alone.
Read the detailed description
The study includes a safety run-in period in which the first 15 patients enrolled will be assigned to receive the study drug SDX-7320 in combination with eribulin. Upon safety confirmation, randomization will commence for the subsequent 40 patients enrolled.
- Being tested
- Eribulin, SDX-7320, Placebo
- Keywords
- Evexomostat (SDX-7320), Eribulin, 22-074
- 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.
EribulinDrug
Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.
SDX-7320Drug
SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SDX-7320 plus Eribulin (safety run-in period) | Experimental | During the safety run-in period, the first 15 patients enrolled will be assigned to received study drug SDX-7320 plus Eribulin. Not randomized. Receives: Drug: Eribulin; Drug: SDX-7320 |
| SDX-7320 plus Eribulin | Experimental | Patients randomized to SDX-7320 plus Eribulin. Receives: Drug: Eribulin; Drug: SDX-7320 |
| Eribulin Plus Placebo | Placebo comparator | Patients randomized to the control arm will receive placebo plus Eribulin. Receives: Drug: Eribulin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in insulin resistance scores (HOMA-IR)
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a validated tool for the assessment of insulin resistance.87 HOMA-IR is calculated as follows: fasting serum insulin (μU/mL) × fasting plasma glucose (mmol L
-1 )/22.5).
Measured: 1 year
Secondary outcomes (2)
Type, frequency and severity of treatment-emergent adverse events
(TEAEs) and laboratory toxicities per the NCI CTCAE version 5.0.
Measured: 2 years
Overall response rate
Response rate will be assessed by RECIST v1.1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start3 Oct 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (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 Memorial Sloan Kettering 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
- Randomised
- Intervention model
- Sequential
- Model description
- This is a multi-center, placebo-controlled phase 2 randomized control trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- SynDevRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Sherry Shen, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570253
- Sponsor's protocol ID
- 22-074
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study
- ClinicalTrials.gov ID
- NCT05570253
- Acronym / sponsor ID
- 22-074
- Keywords
- Evexomostat (SDX-7320), Eribulin, 22-074
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- SynDevRx, Inc.
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Oct 2022 (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.
The researchers are doing this study to find out whether the study drug, SDX-7320, when combined with the standard chemotherapy eribulin, is an effective treatment for people with TNBC and metabolic dysfunction. The researchers will also look at whether the study treatment (SDX-7320 combined with eribulin) is safe and causes few or mild side effects in participants. The researchers will compare this treatment approach to eribulin alone.
Detailed description
The study includes a safety run-in period in which the first 15 patients enrolled will be assigned to receive the study drug SDX-7320 in combination with eribulin. Upon safety confirmation, randomization will commence for the subsequent 40 patients enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This is a multi-center, placebo-controlled phase 2 randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| SDX-7320 plus Eribulin (safety run-in period) | Experimental | Drug: Eribulin, Drug: SDX-7320During the safety run-in period, the first 15 patients enrolled will be assigned to received study drug SDX-7320 plus Eribulin. Not randomized. |
| SDX-7320 plus Eribulin | Experimental | Drug: Eribulin, Drug: SDX-7320Patients randomized to SDX-7320 plus Eribulin. |
| Eribulin Plus Placebo | Placebo comparator | Drug: Eribulin, Other: PlaceboPatients randomized to the control arm will receive placebo plus Eribulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male or female with histologically and/or cytologically confirmed diagnosis of triple-negative metastatic breast cancer defined as estrogen and progesterone receptor staining ≤10%; and HER2-negative defined as IHC 0 to 1+ at enrolling institution (note: if IHC is equivocal, non-amplified status by FISH is acceptable)
- Advanced (local regionally recurrent, not amenable to curative therapy or surgery) or metastatic stage with up to 2 prior lines of therapy in the advanced or metastatic setting
- Received prior anthracycline and taxane chemotherapy in the neoadjuvant, adjuvant, or metastatic settings and considered appropriate for treatment with single agent eribulin OR was otherwise ineligible to receive anthracycline and/or taxane per treating physician OR patients with de novo metastatic disease.
- Evidence of metabolic dysfunction defined as HbA1c > 5.5 and/or BMI ≥ 30 kg/m^2
- Measurable disease per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), OR at least one evaluable, predominantly lytic bone lesion
Key exclusion criteria (27 listed)
- Three or greater prior lines of therapy for metastatic TNBC
- Known primary brain malignancy, brain metastases or active CNS pathology, any of which as determined by the treating Investigator
- Currently participating in a study of an investigational agent
- Body mass index < 18.5 kg/m2
- Known hypersensitivity to SDX-7320 or eribulin
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 |
|---|---|---|
| EribulinEribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle. | Drug | Eribulin Plus Placebo, SDX-7320 plus Eribulin, SDX-7320 plus Eribulin (safety run-in period) |
| SDX-7320SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis | Drug | SDX-7320 plus Eribulin, SDX-7320 plus Eribulin (safety run-in period) |
| PlaceboPlacebo | Other | Eribulin Plus Placebo |
Primary outcome
change in insulin resistance scores (HOMA-IR)
Time frame: 1 year
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a validated tool for the assessment of insulin resistance.87 HOMA-IR is calculated as follows: fasting serum insulin (μU/mL) × fasting plasma glucose (mmol L -1 )/22.5).
2 secondary outcomes
Type, frequency and severity of treatment-emergent adverse events
Time frame: 2 years
Overall response rate
Time frame: 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 9 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Tiffany Trainia, MD contact
Sherry Shen, MD principal investigator
Memorial Sloan Kettering Cancer Center
10 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 Eribulin and SDX-7320 in people with Breast Cancer and Metastatic Triple-Negative Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 10 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 27 inclusion and 27 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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 Sherry Shen, MD (646-888-5134, shens1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in insulin resistance scores (HOMA-IR) (time frame: 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 9 Sep 2026.