Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Part 1: Breast Cancer (BC)
* Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC
* Part 1A/Part 1D/Part1E also include: Refractory HR-positive/HER2-positive BC
Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests
Part 1F: prostate cancer
Part 2A, 2B, 2C and 2E:
* HR-positive/HER2-negative BC
* Patients who are either postmenopausal women or pre/peri-menopausal (Part 2C only)
Part 1D: metastatic castration resistant prostate cancer
Lesion:
* Part 1: evaluable lesion (including skin or bone lesion only)
* Part 2A, 2B, 2C and 2E: measurable lesion per RECIST v1.1
* Part 2D: Participants with evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded.
Prior systemic Treatment
* Part 1: HR-positive/HER2-negative BC
* At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator
* At least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
* HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy
* Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available
* Part 2A and 2E: participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed
* Part 2B: participants who have not received any prior systemic anti-cancer therapies for advanced/metastatic BC
* Part 2C:
* Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or
* Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal
* One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy
* Part 2D:
* Received prior abiraterone; enzalutamide and CDK4i naive
All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Adequate renal, liver, and bone marrow function
You may not be if
Part 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal
Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor
Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway
Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
Major surgery or radiation within 4 weeks prior to study intervention
Last anti-cancer treatment within 2 weeks prior to study intervention
Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
Pregnant or breastfeeding female participant
Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
