ER-positive HER2-negative metastatic breast cancer
Conditions
Interventions
Sponsors
Kogawa Takahiro
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1 have a diagnosis of invasive carcinoma histologically 2 have a diagnosis of ER and or PgR positive breast cancer 3 have a diagnosis of HER2 negative breast cancer 4 locally advanced or metastatic breast cancer in patients who are not candidates for local treatment 5 without active central nervous system metastasis or carcinomatous meningitis 6 have measurable disease 7 had previously received no more than three lines of endocrine therapy and one line of chemotherapy (Aromatase inhibitors, fulvestrant or tamoxifen). A washout period of at least 21 days is required between last chemotherapy dose and randomization 8 have not previously everolimus, olaparib, palbociclib (except for perioperative therapy) for advanced or metastatic disease. In case of patient who received immune checkpoint inhibitor, patient who enrolled in clinical study {NEWFLAME (nivolumab + abemaciclib + endocrine therapy) or NEWBEAT (nivolumab + bevacizumab + paclitaxel)} . Disease free interval after completion of adjuvant PARP inhibitor should be more than one year. 9 last dose of abemaciclib administered no later than 8 weeks immediate previous treatment with abemaciclib in combination with endocrine therapy that led to a clinical benefit, including CR, PR, or SD, during abemaciclib based treatment more than 6 months confirmed disease progression during immediate previous abemaciclib plus endocrine therapy permitted clinical judgment included adjuvant therapy pretreatment dose of abemaciclib is more than 50mg twice per day 10 must have recovered less than Grade1 from the acute effects of previous therapy 11 patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy A washout period of at least 14 days is required between end of radiotherapy and study entry 12 have undergone major surgery defined as requiring general anesthesia and history of major surgical resection involving the stomach or small bowel within 4 weeks prior to study entry 13 regardless of menopausal status 14 Eastern Cooperative Oncology Group performance status of 0,1 15 are able to swallow tablets 16 without visceral crisis Visceral crisis is not only having metastatic internal organs, life threatening serous multiple organ failure and rapidly progress disease 17 have adequate organ function 18 HBs antigen negative and HBc antibody positive or HBs antibody positive and HBV DNA quantity is below detect sensitivity within one year
Exclusion criteria
Exclusion criteria: 1 have other active malignancies 2 have a history of any of the following conditions, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin including, but not limited to, ventricular tachycardia and ventricular fibrillation, or sudden cardiac arrest 3 have concurrent or history of interstitial lung disease or pneumonitis, including lung fibrosis, radiation induced pneumonitis unnecessary steroid treatment 4 have severe dyspnea at rest or requiring oxygen therapy 5 have pleural effusion or ascites necessary to procedure 6 have a history of disease or ulcerative colitis, preexisting Crohns disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea, history of malabsorption syndrome or other condition that would interfere with enteral absorption 7 severe renal impairment 8 known abnormalities in coagulation such as bleeding diathesis 9 have psychiatric condition that may increase the risk associated with study participation 10 patient has active systemic bacterial infection requiring intravenous antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection such as known human immunodeficiency virus positivity 11 known hypersensitivity to any study drugs 12 The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study 13 other condition that would make the patient inappropriate for entry into this study in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, Clinical benefit rate, Overall survival, Chemotherapy-free interval, Safety, Evaluation of mechanism of sensitivity and resistance to drug | — |
Contacts
Public ContactTakahiro Kogawa
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Outcome results
None listed