Breast CancerPhase 2PELICANNCT03841747
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer
A Phase 2 study testing Pembrolizumab and Paclitaxel in people with Breast Cancer, run by Queen Mary University of London.
Trial summary
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pembrolizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Willing and able to provide written informed consent
- Ability to comply with the protocol
- Female ≥ 18 years of age
- Histologically confirmed metastatic or locally advanced breast cancer that is Luminal B, ER+ve, HER2-ve.
- Patients must have measurable disease.
- Representative formalin-fixed paraffin embedded breast tumour samples from the primary or recurrent cancer.
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- ECOG performance status 0-1
- Adequate haematologic and end-organ function within 28 days prior to the first study treatment
- Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on Day 1 Cycle 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible.
Who cannot join
- Luminal A breast cancer
- Prior chemotherapy for advanced or metastatic disease
- Prior treatment with paclitaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel treatment and randomisation into this study
- Patients with neuropathy ≥ Grade 2
- Previous systemic treatment for other neoplasms within 5 years prior to randomisation.
- Patients with prior allogeneic stem cell or solid organ transplantation.
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- Prior treatment with CD137 agonists, AKT inhibitors, anti-CTLA-4, anti-OX-40, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
- Patients must not have a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy.
- Received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation.
- Administration of a live vaccine within 30 days prior to the first dose of study drug.
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL] -2) within 28days or five half-lives of the drug, whichever is shorter, prior to randomisation.
- History of autoimmune disease.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia requiring steroids, or evidence of active pneumonitis on screening chest CT scan.
- Active infection requiring systemic therapy.
- History of HIV infection
- Known active hepatitis infection.
- Known history of active tuberculosis
About this study
Official title: A Phase II, Randomized Study of Paclitaxel Weekly Plus Pembrolizumab Versus Paclitaxel Weekly in ER-positive, Luminal B Metastatic Breast Cancer
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease.
Patients will be randomised (2:1) to one of the two treatment arms:
- Pembrolizumab plus Paclitaxel
- Paclitaxel
- Conditions
- Breast Cancer
- Being tested
- Pembrolizumab, Paclitaxel
- Keywords
- ER-positive, Metastatic, Locally Advanced, Ki67, PAM50, Pembrolizumab, Paclitaxel, HER2-negative
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called KEYTRUDA, lambrolizumab
200 mg Pembrolizumab IV Q3W.
PaclitaxelDrug
Also called Taxol
80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Paclitaxel | Experimental | 200 mg Pembrolizumab IV Q3W plus 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle. Receives: Drug: Pembrolizumab; Drug: Paclitaxel |
| Paclitaxel | Active comparator | 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival, defined as the time from the date of randomisation to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first.
Measured: At 12months
Overall Survival
Overall Survival is defined as the time from date of randomisation to the date of death due to any cause in all patients.
Measured: At 24 months.
Secondary outcomes (2)
Objective Response Rates
Objective Response Rate is defined as the proportion of the patients in the analysis population who have a CR or PR (using RECIST 1.1).
Measured: Date of first documentation of CR or PR or to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first, assessed up to 30 months.
Safety and tolerability of paclitaxel plus pembrolizumab versus paclitaxel through review of all AEs and SAEs assessed by CTCAE v4.03
Incidence, nature and severity of adverse events with severity determined according to CTCAE v4.03
Measured: Date of randomisation to date of all adverse event resolution following discontinuation for any reason or death, assessed up to 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startDec 2020 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Funding restrictions
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 Queen Mary University of LondonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, European Institute of Oncology
- Responsible party
- Sponsor
- Investigators
- Peter Schmid, MD PhD FRCP, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841747
- Sponsor's protocol ID
- 012342QM
- Other IDs
- 2018-000188-10, 2018
- Acronym
- PELICAN
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2019
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized Study of Paclitaxel Weekly Plus Pembrolizumab Versus Paclitaxel Weekly in ER-positive, Luminal B Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03841747
- Acronym / sponsor ID
- PELICAN / 012342QM
- Conditions
- Breast Cancer
- Keywords
- ER-positive, Metastatic, Locally Advanced, Ki67, PAM50, Pembrolizumab, Paclitaxel, HER2-negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding restrictions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, European Institute of Oncology
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Feb 2019 (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.
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease.
Patients will be randomised (2:1) to one of the two treatment arms:
- Pembrolizumab plus Paclitaxel
- Paclitaxel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Paclitaxel | Experimental | Drug: Pembrolizumab, Drug: Paclitaxel200 mg Pembrolizumab IV Q3W plus 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle. |
| Paclitaxel | Active comparator | Drug: Paclitaxel80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to provide written informed consent
- Ability to comply with the protocol
- Female ≥ 18 years of age
- Histologically confirmed metastatic or locally advanced breast cancer that is Luminal B, ER+ve, HER2-ve.
- Patients must have measurable disease.
Key exclusion criteria (17 listed)
- Luminal A breast cancer
- Prior chemotherapy for advanced or metastatic disease
- Prior treatment with paclitaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel treatment and randomisation into this study
- Patients with neuropathy ≥ Grade 2
- Previous systemic treatment for other neoplasms within 5 years prior to randomisation.
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, lambrolizumab200 mg Pembrolizumab IV Q3W. | Drug | Pembrolizumab + Paclitaxel |
| PaclitaxelAlso: Taxol80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle. | Drug | Paclitaxel, Pembrolizumab + Paclitaxel |
Primary outcome
Progression-free survival
Time frame: At 12months
Progression-free survival, defined as the time from the date of randomisation to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first.
Overall Survival
Time frame: At 24 months.
Overall Survival is defined as the time from date of randomisation to the date of death due to any cause in all patients.
2 secondary outcomes
Objective Response Rates
Time frame: Date of first documentation of CR or PR or to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first, assessed up to 30 months.
Safety and tolerability of paclitaxel plus pembrolizumab versus paclitaxel through review of all AEs and SAEs assessed by CTCAE v4.03
Time frame: Date of randomisation to date of all adverse event resolution following discontinuation for any reason or death, assessed up to 30 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Peter Schmid, MD PhD FRCP principal investigator
Queen Mary University of London
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Paclitaxel in people with Breast Cancer, run by Queen Mary University of London.
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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: At 12months). The study lists 2 primary outcomes in all. 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 12 Mar 2024.