Breast CancerPhase 2NCT05966584
A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
A Phase 2 study testing Benralizumab and fulvestrant or AIs) and PI3K inhibition (alpelisib) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Benralizumab and fulvestrant or AIs) and PI3K inhibition (alpelisib)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Jul 2023to 2 Aug 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic HR-positive, HER2-negative breast cancer. HR positive is defined by ER status >10% immunohistochemical (IHC) staining of any intensity.
- Must be scheduled to receive SOC endocrine therapy (alpelisib plus fulvestrant or AIs)
- Presence of one or more activating PIK3CA mutations in tumor tissue.
- Measurable disease per RECIST v1.1 OR at least one predominantly lytic bone lesion must be present.
- Written informed consent provided
- Female or male ≥18 years of age
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- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy ≥6 months.
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥8.0 g/dL (without blood transfusion within 7 days of laboratory test used to determine eligibility)
- Absolute neutrophil count ≥1.0 × 10^9 /L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
- Platelet count ≥50 × 10^9 /L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
- Total bilirubin (TB) ≤1.0 × institutional upper limit of normal (ULN; Patients with known Gilbert's disease who have TB ≤3 × ULN may be enrolled)
- Aspartate transaminase/alanine transaminase ≤2.5 × ULN with normal alkaline phosphatase (≤5 × ULN for patients with liver metastases) OR ≤1.5 × ULN in conjunction with alkaline phosphatase >2.5 × ULN
- Creatinine ≤1.5 mg/dL
- Able to swallow oral medication.
- Willing to be randomized to any of the treatment arms and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- Women must be of postmenopausal status. Postmenopausal status is defined by any one of the following criteria:
- Prior bilateral oophorectomy
- Age ≥60 years
- Age <60 years and amenorrheic for at least 12 months (spontaneous cessation of menses for 12 consecutive months or more in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone and estradiol levels in the postmenopausal range without an alternative cause.
Who cannot join
- Known hypersensitivity to alpelisib, fulvestrant or AIs, benralizumab, cetirizine, or to any of the excipients of alpelisib, fulvestrant or AIs, benralizumab, or cetirizine.
- Concurrent malignancy (basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone curative intent therapy are allowed)
- Individuals with impaired decision making capacity.
- Concurrent use of another investigational drug or device for the rash (i.e., outside of study treatment) during, or within 4 weeks of treatment.
- Known use of anti-IL-5 agents or other biologics for the treatment of asthma which are known to decrease blood eosinophil levels within the past 12 weeks.
- Known history of anaphylaxis to benralizumab therapy.
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- A helminthic parasitic infection diagnosed within 24 weeks prior to the first treatment, and assent when applicable, was obtained that had not been treated with, or has failed to respond to, standard of care therapy.
- Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
- Active infection that would impair the ability of the patient to receive study treatment.
- Women who are pregnant or breast-feeding.
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
- Oral corticosteroids at a dose of ≥20mg/day prednisone or equivalent within 14 days expected to continue during alpelisib therapy.
- More than 2 lines of endocrine-based therapy in the metastatic setting.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Rockville (Limited Protocol Activities)
Rockville Centre, New York, 11570
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib. Researchers think adding benralizumab to the standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.
- Conditions
- Breast Cancer
- Being tested
- Benralizumab, fulvestrant or AIs) and PI3K inhibition (alpelisib)
- Keywords
- Alpelisib, Benralizumab, Metastatic HR-positive, HER2-negative breast cancer, Rash, 22-276
- Medical subject headings
- Breast Neoplasms, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabDrug
Benralizumab 30mg subcutaneously on day -1.
fulvestrant or AIs) and PI3K inhibition (alpelisib)Drug
SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab and PI3K inhibition (alpelisib) | Experimental | Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1. Receives: Drug: Benralizumab; Drug: fulvestrant or AIs) and PI3K inhibition (alpelisib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects That Have a Grade ≤1 Rash
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start6 Jul 2023
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Why it stopped: Limited amount of eligible participants
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A multi-center, open-label, phase 2 trial
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Alina Markova, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966584
- Sponsor's protocol ID
- 22-276
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2023
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05966584
- Acronym / sponsor ID
- 22-276
- Conditions
- Breast Cancer
- Keywords
- Alpelisib, Benralizumab, Metastatic HR-positive, HER2-negative breast cancer, Rash, 22-276
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited amount of eligible participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, Novartis Pharmaceuticals
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib. Researchers think adding benralizumab to the standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multi-center, open-label, phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| Benralizumab and PI3K inhibition (alpelisib) | Experimental | Drug: Benralizumab, Drug: fulvestrant or AIs) and PI3K inhibition (alpelisib)Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed metastatic HR-positive, HER2-negative breast cancer. HR positive is defined by ER status >10% immunohistochemical (IHC) staining of any intensity.
- Must be scheduled to receive SOC endocrine therapy (alpelisib plus fulvestrant or AIs)
- Presence of one or more activating PIK3CA mutations in tumor tissue.
- Measurable disease per RECIST v1.1 OR at least one predominantly lytic bone lesion must be present.
- Written informed consent provided
Key exclusion criteria (13 listed)
- Known hypersensitivity to alpelisib, fulvestrant or AIs, benralizumab, cetirizine, or to any of the excipients of alpelisib, fulvestrant or AIs, benralizumab, or cetirizine.
- Concurrent malignancy (basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone curative intent therapy are allowed)
- Individuals with impaired decision making capacity.
- Concurrent use of another investigational drug or device for the rash (i.e., outside of study treatment) during, or within 4 weeks of treatment.
- Known use of anti-IL-5 agents or other biologics for the treatment of asthma which are known to decrease blood eosinophil levels within the past 12 weeks.
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 |
|---|---|---|
| BenralizumabBenralizumab 30mg subcutaneously on day -1. | Drug | Benralizumab and PI3K inhibition (alpelisib) |
| fulvestrant or AIs) and PI3K inhibition (alpelisib)SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib) | Drug | Benralizumab and PI3K inhibition (alpelisib) |
Primary outcome
Proportion of Subjects That Have a Grade ≤1 Rash
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
Alina Markova, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 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 Benralizumab and fulvestrant or AIs) and PI3K inhibition (alpelisib) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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 21 inclusion and 13 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: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 29 Aug 2024). 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?
Proportion of Subjects That Have a Grade ≤1 Rash (time frame: 4 weeks). 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 29 Aug 2024.