BridgeMD
New treatment option for Triple Negative Breast Cancer
Official title PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT04360941
What this study is testing
What is Palbociclib?
Palbociclib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
Also referred to as Ibrance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part A:
- Patients with recurrent inoperable locally advanced or metastatic breast cancer.
- Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced...
- Measurable disease (RECIST 1.1)
- Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7...
You likely can't join if
- Parts A \& B:
- Oral chemotherapy within two weeks, weekly iv chemotherapy within three weeks or any other systemic chemotherapy or investigational medicinal...
- Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand...
- Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting. (Note: Patients who have received...
- Previous treatment with palbociclib or any agents which inhibit CDK4/6. (Note: Patients who have received adjuvant abemaciclib or ribociclib for...
- Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry
See the full eligibility criteria
Who can join
- Part A:
- Patients with recurrent inoperable locally advanced or metastatic breast cancer.
- Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. Patients with ER+ breast cancer must have received at least...
- Measurable disease (RECIST 1.1)
- Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.
- Women/female patients with child-bearing potential (defined as the fertile status following menarche and until becoming post-menopausal unless permanently sterile by methods that include hysterectomy, bilateral...
- Oral, intra-vaginal or transdermal combined hormonal contraception
- Oral, injectable or implantable progesterone-only contraception
- Intrauterine device
- Intrauterine hormone-releasing system,
- Bilateral tubal occlusion
- Vasectomised partner
- True abstinence:\ When this is in line with the preferred and usual lifestyle of the subject Key: \ it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of...
- 18 years of age or over.
- World Health Organisation (WHO) performance status 0 or 1
- Estimated life expectancy of at least 3 months in the opinion of the investigator
- Signed and dated informed consent.
- Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up and other procedures Part B:
- Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. Archival...
- Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease.
- Measurable disease (RECIST 1.1) amenable to fresh biopsy
- Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.
- Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. Women/females of child bearing potential or their male partners must use a highly...
- Oral, intra-vaginal or transdermal combined hormonal contraception
- Oral, injectable or implantable progesterone-only contraception
- Intrauterine device
- Intrauterine hormone-releasing system,
- Bilateral tubal occlusion
- Vasectomised partner
- True abstinence:\ When this is in line with the preferred and usual lifestyle of the subject Key: \ it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of...
- Age 18 years of age or over
- World Health Organisation (WHO) performance status 0 or 1
- Estimated life expectancy of at least 3 months in the opinion of the investigator
- Signed and dated informed consent
- Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up, and other procedures
- Available archival breast primary tumour tissue (or metastatic tissue if de novo metastatic disease)
- Patient willing to undergo a mandatory baseline fresh tumour tissue biopsy procedure (clinical or radiologically-guided)
What rules you out
- Parts A \& B:
- Oral chemotherapy within two weeks, weekly iv chemotherapy within three weeks or any other systemic chemotherapy or investigational medicinal products during the previous four weeks.
- Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases.
- Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting. (Note: Patients who have received neoadjuvant and/or adjuvant pembrolizumab are eligible if treatment was...
- Previous treatment with palbociclib or any agents which inhibit CDK4/6. (Note: Patients who have received adjuvant abemaciclib or ribociclib for early breast cancer are eligible if treatment was completed at least 12...
- Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry
- Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases, leptomeningeal disease or spinal cord compression.
- Active infection requiring systemic therapy
- Any of the following within 12 months prior to study entry: myocardial infarction, history of myocarditis, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure...
- Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive...
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic...
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis (even if fully resolved), pulmonary fibrosis, end stage renal disease on haemodialysis or psychiatric...
- Patients on warfarin or direct acting oral anticoagulants. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.
- Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 5), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- Inability or unwillingness to swallow pills, or receive IV injections.
- Persisting toxicity related to prior therapy \>Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).
- Pregnancy or lactation (women/females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)
- Diagnosis of other malignancy within 3 years, except for previous breast cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, or low-grade (Gleason ≤6) prostate cancer
- Is a participant or plans to participate in another treatment clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.
- Known prior or suspected hypersensitivity to investigational products or to any of the excipients
- Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. Live vaccines must also be avoided for 3 months after the last dose of...
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Requirement for continued use of preparations containing St. John's Wort is specifically contraindicated. Other herbal medicinal or natural products that patient is intended to take during the trial must be explored at...
- Requirement for continued use of CYP3A inhibitors, inducers or substrates (listed in Appendix 4).
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as this medicinal product contains lactose.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Manchester, Greater Manchester, United Kingdom
- Cambridge, United Kingdom
- Glasgow, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Nottingham, United Kingdom
- Sheffield, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manchester, Greater Manchester, United Kingdom; Cambridge, United Kingdom; Glasgow, United Kingdom; Leicester, United Kingdom; London, United Kingdom; Nottingham, United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.