Breast CancerPhase 2KELLYNCT03222856

Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes

A Phase 2 study testing Pembrolizumab and Eribulin in people with Breast Cancer, run by MedSIR at 11 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Pembrolizumab and Eribulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 11 sitesSpain
Study dates: 14 Dec 2017to 23 Dec 2020
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent prior to beginning specific protocol procedures.
Female patients ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 which the Investigator believes is stable at the time of screening.
Life expectancy ≥ 12 weeks.
Patients have a histologically and/or cytologically confirmed diagnosis of breast cancer.
Patients have radiologic evidence of inoperable locally recurrent or MBC.

Show all 21Show fewer

Patients have HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization (ISH) test or an immunohistochemistry (IHC) status of 0, 1+, or 2+ (if IHC 2+, a negative ISH test is required) by local laboratory testing.
Patients have HR-positive breast cancer defined as estrogen receptor (ER) and/or progesterone receptor (PR) with >1% of tumor cells positive for ER and/or PR by IHC irrespective of staining intensity.
Available tumor tissue for PD-L1 biomarker analysis from a newly obtained core or excisional biopsy since last progression of a metastatic tumor lesion not previously irradiated.
Note: Subjects for whom tumor biopsies cannot be obtained (e.g., inaccessible tumor or subject safety concern) may submit an archived metastatic tumor specimen only upon agreement from the Sponsor.
Patients have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 as assessed by site Investigator and local radiology review.
Patients have received at least one, but not more than two, prior chemotherapeutic regimens for locally recurrent and/or metastatic disease. Prior therapy must have included an anthracycline and a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient. Prior anti-hormonal therapy is mandatory.
Patients have adequate bone marrow and organ function as defined by the following laboratory values:
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.
Platelets ≥ 100 x 10^9/L.
Hemoglobin ≥ 9 g/dL.
Potassium, calcium (corrected for serum albumin), and magnesium within normal limits for the institution.
Serum creatinine ≤ 1.5 x upper limit of normal (ULN).
Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 x ULN (or ≤ 5.0 x ULN if liver metastases are present).
Total serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present). Patients with known Gilbert disease who have serum bilirubin ≤ 3 x ULN may be enrolled.
Patients must be accessible for treatment and follow-up.

Who cannot join

Patients have received previous treatment with eribulin and an/or anti-PD1 or anti-PD-L1 agents.
Patients have a known hypersensitivity to any of the excipients of MK3475 (pembrolizumab) or eribulin.
Patients who have received chemotherapy, targeted small molecule therapy, or radiotherapy within two weeks of first dose of study treatment.
Patients who have received monoclonal antibodies for direct antineoplastic treatment or an investigational agent/device within four weeks of first dose of study treatment.
Patients have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Note: Known brain metastases are considered active, if any of the following criteria is applicable:

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Brain imaging during screening demonstrates progression of existing metastases and/or appearance of new lesions compared to brain imaging performed at least four weeks earlier.
Neurological symptoms attributed to brain metastases have not returned to baseline.
Steroids were used for brain metastases within 28 days of first dose of study treatment.
Patients have peripheral neuropathy grade 2 or more.
Patients have a concurrent malignancy or malignancy within five years of study enrollment (with the exception of adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer).
Patients have not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy.
Patients have had a major surgical procedure within 28 days prior to starting study drug.
Patients have an active cardiac disease or a history of cardiac dysfunction including any of the following:
Unstable angina pectoris or documented myocardial infarction within six months prior to study entry.
Symptomatic pericarditis.
History of documented congestive heart failure (New York Heart Association functional classification III-IV).
Patients have a left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
Patients have any of the following cardiac conduction abnormalities:
Ventricular arrhythmias except for benign premature ventricular contractions.
Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication.
Conduction abnormality requiring a pacemaker.
Other cardiac arrhythmia not controlled with medication.
Uncontrolled hyper/hypothyroidism or type 1 diabetes mellitus (T1DM). Patients with hypothyroidism stable on hormone replacement will not be excluded from the trial. Patients with controlled T1DM on a stable insulin regimen may be eligible for this study.
Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that has required systemic treatment (steroids or immunosuppressive agents) in the past two years.
Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic steroid replacement therapy (≤ 10 mg prednisone daily) for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Prior allogenic stem cell or solid organ transplantation.
Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease.
Active uncontrolled infection at the time of screening
Active tuberculosis.
Current known infection with HIV.
Active hepatitis B (HBV) [patients with negative hepatitis B surface antigen (HBsAg) test and a positive antibody to HBsAg (anti-HBsAg) test at screening are eligible] or hepatitis C (HCV) [patients with a positive antibody to hepatitis C (anti-HCV) are eligible only if polymerase chain reaction (PCR) is negative for virus hepatitis C RNA].
Patients have any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment contraindicate patient participation in the clinical study.
Treatment with systemic steroids (standard premedication for chemotherapy/contrast reactions, inhaled steroids, and local applications are allowed) or another immunosuppressive agent within seven days prior to study treatment initiation.
Has received live vaccines within 30 days prior to first dose of study treatment.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study unless they are using highly effective methods of contraception during dosing and up to 120 days after study drugs discontinuation.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Spain11 sites

Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña
Hospital Clínic de Barcelona
Barcelona
Instituto Oncológico Baselga - Hospital Quirónsalud Barcelona
Barcelona
Hospital Universitario Ramón y Cajal
Madrid
MD Anderson
Madrid
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Hospital de Navarra
Pamplona, Navarre
Corporació Sanitaria Sanitari Parc Taulí
Sabadell, Barcelona
Hospital Universitario Virgen del Rocío
Seville
Hospital Arnau de Vilanova de Valencia
Valencia
Hospital Clínico de Valencia
Valencia

Other trials in Spain

About this study

Official title: A Phase II Study of Pembrolizumab and Eribulin in Patients With HR-positive/HER2-negative Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

This a multicenter, open-label, phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients older than 18 years old with hormone receptor-(HR)positive/HER2-negative metastatic breast cancer (MBC) previously treated with at least one, but not more than two, prior chemotherapeutic regimens for treatment of locally recurrent and/or metastatic disease. Prior therapy must have included an anthracycline and a taxane and prior anti-hormonal therapy is mandatory.

The number of patients to be included is 44 patients at 11 sites. All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle.

Read the detailed description

The number of patients to be included is 44 patients at 11 sites. The primary objective is to assess the efficacy -as determined by the clinical benefit rate (CBR) (total number of objective responses plus stable disease for at least 24 weeks) based on RECIST v.1.1- of MK3475 (pembrolizumab) in combination with eribulin.

Primary endpoint is CBR based on RECIST v.1.1. All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.

Available tumor tissue for PD-L1 biomarker analysis from a newly obtained core or excisional biopsy since last progression of a metastatic tumor lesion not previously irradiated is requested for this study.

Translational research of this protocol involves the collection, processing, temporary storage, and shipment of samples from consenting patients enrolled in centers selected for participation in the study. The study plan includes collection and initial processing of tumor tissues and blood samples to the central laboratory of Institut Hospital del Mar d"Investigacions Mèdiques (IMIM), that will be used to identify dynamic biomarkers that may be predictive of response to MK3475 (pembrolizumab) and eribulin treatment.

Conditions: Breast Cancer
Being tested: Pembrolizumab, Eribulin
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, MK3475
MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
EribulinDrug
Also called Halaven
Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.

Study groups in NCT03222856
Study group	Role	What they receive
Pembrolizumab + eribulin	Experimental	All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose. Receives: Drug: Pembrolizumab; Drug: Eribulin

What is being measured

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

Efficacy of Pembrolizumab in Combination With Eribulin.
The efficacy -as determined by the clinical benefit rate (CBR) (total number of objective responses plus stable disease for at least 24 weeks) based on RECIST v.1.1- of MK3475 (pembrolizumab) in combination with eribulin in patients with HR-positive/HER2-negative MBC who have previously received an anthracycline and a taxane (for either early or advanced disease), unless contraindicated, and between one to two lines of chemotherapy in the metastatic setting.
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a decrease of ≥30% in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as Progressive Disease (PD).
Measured: Through study completion. From baseline up to 36 months.

Secondary outcomes (10)

The CBR in Subjects With Programmed Death Ligand-1 (PD-L1) Positive Tumors.
CBR based on RECIST v.1.1 in subjects with PD-L1 positive tumors.
Measured: Through study completion. From baseline up to 36 months.
The Progression-free Survival (PFS)
PFS based on RECIST v.1.1.
Measured: Through study completion. From baseline up to 36 months.
The PFS in Subjects With PD-L1 Positive Tumors.
PFS based on RECIST v.1.1 in subjects with PD-L1 positive tumors.
Measured: Through study completion. From baseline up to 36 months.
Overall Survival (OS)
Overall survival (OS) represents the time from the start of the study until death from any cause.
Measured: From baseline up to 36 months.
The OS in Subjects With PD-L1 Positive Tumors.
OS in subjects with PD-L1 positive tumors.
Measured: Through study completion. From baseline up to 36 months.
Overall Response Rate (ORR) Based on RECIST v1.1
The Overall Response Rate (ORR) is defined as the proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1 criteria. ORR is calculated as:
ORR = (Number of participants with CR + Number of participants with PR) / Total number of participants.
Measured: Through study completion. From baseline up to 36 months.
Overall Response Rate (ORR) in Participants With PD-L1 Positive Tumors Based on RECIST v1.1
The Overall Response Rate (ORR) in participants with PD-L1 positive tumors is defined as the proportion of participants with a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1 criteria. ORR is calculated as:
ORR = (Number of participants with CR + Number of participants with PR) / Total number of participants with PD-L1 positive tumors.
Measured: Through study completion. From baseline up to 36 months.
The Duration of Response (DoR)
DoR based on RECIST v.1.1.
Measured: Through study completion. From baseline up to 36 months.
The DoR in Subjects With PD-L1 Positive Tumors.
DoR based on RECIST v.1.1 in subjects with PD-L1 positive tumors.
Measured: Through study completion. From baseline up to 36 months.
Number of AEs Per CTCAE Grade (Safety and Tolerability of Pembrolizumab in Combination With Eribulin)
The safety and tolerability of MK3475 (pembrolizumab) in combination with eribulin according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3.
Measured: Through study completion. From baseline up to 36 months.

Timeline

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

14 Dec 201723 Dec 2020

First posted19 Jul 2017
Study start14 Dec 2017
Primary completion31 Oct 2018
Study completion23 Dec 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: A phase II, multicenter, open-label study of pembrolizumab and eribulin in patients with HR- positive/HER2-negative metastatic breast cancer previously treated with anthracyclines and taxanes.
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03222856
Sponsor's protocol ID: MedOPP127
Other IDs: 2016-004513-27, 2016
Acronym: KELLY
Status last verified: May 2025
First submitted: 13 Jul 2017
Last updated: 5 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Perez-Garcia JM, Llombart-Cussac A, G Cortes M, Curigliano G, Lopez-Miranda E, Alonso JL, Bermejo B, Calvo L, Caranana V, de la Cruz Sanchez S, M Vazquez R, Prat A, R Borrego M, Sampayo-Cordero M, Segui-Palmer MA, Soberino J, Malfettone A, Schmid P, Cortes J. Pembrolizumab plus eribulin in hormone-receptor-positive, HER2-negative, locally recurrent or metastatic breast cancer (KELLY): An open-label, multicentre, single-arm, phase Ⅱ trial. Eur J Cancer. 2021 May;148:382-394. doi: 10.1016/j.ejca.2021.02.028. Epub 2021 Mar 29.
PubMed 33794440

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Pembrolizumab and Eribulin in Patients With HR-positive/HER2-negative Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
ClinicalTrials.gov ID: NCT03222856
Acronym / sponsor ID: KELLY / MedOPP127
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: MedSIRUniversity, hospital or other
Study start: 14 Dec 2017 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 23 Dec 2020 (actual)
First posted: 19 Jul 2017 (actual)
Results: Posted 19 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A phase II, multicenter, open-label study of pembrolizumab and eribulin in patients with HR- positive/HER2-negative metastatic breast cancer previously treated with anthracyclines and taxanes.

Arm	Type	Receives
Pembrolizumab + eribulin	Experimental	Drug: Pembrolizumab, Drug: EribulinAll eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Written informed consent prior to beginning specific protocol procedures.
Female patients ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 which the Investigator believes is stable at the time of screening.
Life expectancy ≥ 12 weeks.
Patients have a histologically and/or cytologically confirmed diagnosis of breast cancer.

Key exclusion criteria (36 listed)

Patients have received previous treatment with eribulin and an/or anti-PD1 or anti-PD-L1 agents.
Patients have a known hypersensitivity to any of the excipients of MK3475 (pembrolizumab) or eribulin.
Patients who have received chemotherapy, targeted small molecule therapy, or radiotherapy within two weeks of first dose of study treatment.
Patients who have received monoclonal antibodies for direct antineoplastic treatment or an investigational agent/device within four weeks of first dose of study treatment.
Patients have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

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, MK3475MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.	Drug	Pembrolizumab + eribulin
EribulinAlso: HalavenEribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.	Drug	Pembrolizumab + eribulin

Primary outcome

Efficacy of Pembrolizumab in Combination With Eribulin.
Time frame: Through study completion. From baseline up to 36 months.
The efficacy -as determined by the clinical benefit rate (CBR) (total number of objective responses plus stable disease for at least 24 weeks) based on RECIST v.1.1- of MK3475 (pembrolizumab) in combination with eribulin in patients with HR-positive/HER2-negative MBC who have previously received an anthracycline and a taxane (for either early or advanced disease), unless contraindicated, and between one to two lines of chemotherapy in the metastatic setting. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a decrease of ≥30% in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as Progressive Disease (PD).

10 secondary outcomes

The CBR in Subjects With Programmed Death Ligand-1 (PD-L1) Positive Tumors.
Time frame: Through study completion. From baseline up to 36 months.
The Progression-free Survival (PFS)
Time frame: Through study completion. From baseline up to 36 months.
The PFS in Subjects With PD-L1 Positive Tumors.
Time frame: Through study completion. From baseline up to 36 months.
Overall Survival (OS)
Time frame: From baseline up to 36 months.
The OS in Subjects With PD-L1 Positive Tumors.
Time frame: Through study completion. From baseline up to 36 months.
Overall Response Rate (ORR) Based on RECIST v1.1
Time frame: Through study completion. From baseline up to 36 months.
Overall Response Rate (ORR) in Participants With PD-L1 Positive Tumors Based on RECIST v1.1
Time frame: Through study completion. From baseline up to 36 months.
The Duration of Response (DoR)
Time frame: Through study completion. From baseline up to 36 months.
The DoR in Subjects With PD-L1 Positive Tumors.
Time frame: Through study completion. From baseline up to 36 months.
Number of AEs Per CTCAE Grade (Safety and Tolerability of Pembrolizumab in Combination With Eribulin)
Time frame: Through study completion. From baseline up to 36 months.

Results and safety

Results posted to the registry on 19 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pembrolizumab + Eribulin	44	37

Primary outcome: Efficacy of Pembrolizumab in Combination With Eribulin.

Time frame: Through study completion. From baseline up to 36 months.. Count of participants. Unit: Participants

Measure	Pembrolizumab + Eribulin n = 44
Value	25

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pembrolizumab + Eribulin	0 of 44 (0%)	44 of 44 (100%)	11 of 44

Limitations and caveats (from the sponsor): There were not enough events in the SOC arm (patients discharged) to estimate the upper limit of the 95% confidence interval in the Duration of Response (DoR) endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33794440Perez-Garcia JM, Llombart-Cussac A, G Cortes M, Curigliano G, Lopez-Miranda E, Alonso JL, Bermejo B, Calvo L, Caranana V, de la Cruz Sanchez S, M Vazquez R, Prat A, R Borrego M, Sampayo-Cordero M, Segui-Palmer MA, Soberino J, Malfettone A, Schmid P, Cortes J. Pembrolizumab plus eribulin in hormone-receptor-positive, HER2-negative, locally recurrent or metastatic breast cancer (KELLY): An open-label, multicentre, single-arm, phase Ⅱ trial. Eur J Cancer. 2021 May;148:382-394. doi: 10.1016/j.ejca.2021.02.028. Epub 2021 Mar 29.
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. This study is not recruiting at the moment.

Javier Cortés, PhD principal investigator

MedSIR

11 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 Eribulin in people with Breast Cancer, run by MedSIR at 11 sites in Spain.

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 21 inclusion and 36 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. 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 19 Feb 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?

Efficacy of Pembrolizumab in Combination With Eribulin. (time frame: Through study completion. From baseline up to 36 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03222856, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.