Actively Recruiting
PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
Led by Royal Marsden NHS Foundation Trust · Updated on 2026-04-06
45
Participants Needed
9
Research Sites
311 weeks
Total Duration
On this page
Sponsors
R
Royal Marsden NHS Foundation Trust
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab. The study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer. It is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.
CONDITIONS
Official Title
PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with recurrent inoperable locally advanced or metastatic breast cancer (Part A)
- Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with confirmed receptor status (Part B)
- Previously treated with at least one but no more than two prior lines of chemotherapy for advanced disease
- Patients with ER+ breast cancer must have received at least one prior hormone therapy; HER2+ breast cancer patients must have received at least one prior HER2-directed therapy
- Measurable disease according to RECIST 1.1 criteria
- Haematological and biochemical tests within required ranges within 7 days before starting trial
- Women with child-bearing potential must have a negative pregnancy test within 7 days prior to trial
- Use of highly effective contraception before, during, and after treatment for females and their male partners
- Age 18 years or older
- WHO performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Signed and dated informed consent
- Willing and able to comply with study visits, treatments, laboratory tests, and follow-up
- For Part B, available archival breast tumour tissue and willingness to undergo mandatory fresh tumour biopsy
You will not qualify if you...
- Recent chemotherapy or investigational treatments within specified washout periods (oral chemotherapy within 2 weeks, IV chemotherapy within 3 weeks, other systemic therapy within 4 weeks)
- Hormonal therapy within 7 days except specific ovarian suppression treatments
- Prior exposure to immune checkpoint inhibitors in advanced setting (except certain neoadjuvant/adjuvant treatments completed 6 months prior)
- Previous treatment with palbociclib or other CDK4/6 inhibitors (with exceptions for adjuvant treatments completed 12 months prior)
- Major surgery within 4 weeks or radiation therapy within 14 days before study entry
- Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
- Active infections requiring systemic therapy
- Significant cardiovascular events or uncontrolled cardiac conditions within 12 months
- Active autoimmune diseases likely to worsen with immunotherapy (some exceptions apply)
- Current use of immunosuppressive medications except certain low-dose or local steroids
- Severe acute or chronic medical conditions or psychiatric illness affecting safety or study compliance
- Use of warfarin or direct oral anticoagulants (unless switched to low-molecular weight heparin)
- Known HIV/AIDS or active hepatitis infections
- Severe allergies or asthma related to monoclonal antibodies
- Inability or unwillingness to swallow pills or receive IV injections
- Persisting toxicity from prior therapy above specified grades
- Pregnancy or lactation
- Other malignancies within 3 years except certain skin or cervical cancers
- Participation in another interventional clinical trial during this study
- Known hypersensitivity to study drugs or excipients
- Recent vaccination with live vaccines or vaccination within 4 weeks before starting avelumab
- Psychiatric conditions preventing informed consent
- Use of St. John's Wort or certain herbal medicines during the trial
- Use of CYP3A inhibitors, inducers, or substrates as specified
- Rare hereditary conditions related to lactose intolerance
- Any condition judged by the investigator as unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 9 locations
1
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX
Actively Recruiting
2
Addenbrooke's Hospital Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
3
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
4
Hope Clinical Trials Cancer Centre
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
5
Barts Cancer Institute
London, United Kingdom, EC1M 6BQ
Actively Recruiting
6
Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
7
University College London Hospitals NHS Foundation Trust
London, United Kingdom, W1T 7HA
Actively Recruiting
8
Nottingham University Hospital
Nottingham, United Kingdom, NG5 1PB
Active, Not Recruiting
9
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
Research Team
O
Orla Batchelor
CONTACT
D
Dr Alicia Okines
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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