Hormone receptor-positive, HER2-negative inoperable or recurrent breast cancer Hormone receptor-positive, HER2-negative inoperable or recurrent breast cancer
Conditions
Interventions
-_After the primary enrollment, AI + ABE will be administered with the same dosage and administration as those before the primary.
-_Patients who are confirmed not to have PD in the tumor evaluation a
Sponsors
Yoshinami Tetsuhiro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: primary enrollment (1) Histologically diagnosed with invasive breast cancer. (2) Confirmed ER-positive or PgR-positive (>= 1% positive cells by IHC or an Allred score of >= 3). (3) Confirmed HER2-negative (IHC 0 or 1, or FISH/DISH-negative). (4) Diagnosed with advanced or metastatic breast cancer. Note -Aromatase inhibitor + abemaciclib combination therapy" includes LH-RH agonist combination therapy based on menopausal status prior to the start of treatment. (5) Age >= 18 years at the time of informed consent. (6) Women in menopause lasting more than 3 months (including in combination with LH-RH agonists). (7) Performance status (PS) of 0 or 1 according to the ECOG criteria. (8) Aromatase inhibitor + abemaciclib combination therapy has been administered as the first-line treatment for advanced metastatic breast cancer, and both drugs have been continued for >= 6 to =1,500/mm3(>=1.5 x 109/L) [2] Hemoglobin >= 8.0 g/dL* (*Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion. [3] Platelet count >= 10 x 104/mm3 (100x109/L) [4] Total bilirubin <= 1.5 mg/dL*1 *1 Patients with Gilbert's syndrome with a total bilirubin <=2.0 times ULN and direct bilirubin within normal limits are permitted. [5] AST (GOT) <= 120 IU/L [6] ALT (GPT) <= 120 IU/L [7] Serum creatinine <= 2.0 mg/dL* *Even if the above value is exceeded, the patient may be enrolled if the renal function is confirmed to be normal based on the measurement of serum cystatin C within 28 days before the day of primary enrollment. (13) Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade <=1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy) (14) Patients who received radiothe
Exclusion criteria
Exclusion criteria: primary enrollment (1) The patient has concurrent or history of interstitial lung disease (ILD)/pneumonitits, including lung fibrosis. (2) Patients with central nervous system metastases or carcinomatous meningitis, either active or inactive. (3) Patients with active double cancer (synchronous or metachronous with disease-free period within 2years before the day of primary enrollment) other than breast cancer. However, even if the disease-free period is = 95% such as those in the following pathological stages that were totally resected: - Gastric cancer "adenocarcinoma (common type)," stage 0 to I; colon cancer (adenocarcinoma), stage 0 to I; rectal cancer (adenocarcinoma), stage 0 to I;esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma), stage 0; and endometrial cancer - (Endometrioid adenocarcinoma and mucinous adenocarcinoma), stage I; cervical cancer (squamous cell carcinoma), stage 0; thyroid cancer (papillary carcinoma and follicular carcinoma), stages I, II, and III; renal cancer (clear cell carcinoma and chromophobe cell carcinoma), stage I; and other lesions equivalent to intramucosal carcinoma - In principle, staging will follow the UICC TNM 7th edition or equivalent cancer handling rules. (4) Patients with a history of breast cancer other than hormone receptor-positive, HER2-negative breast cancer that is synchronous or for which the disease-free period is = 300 mg/dL or HbA1c of >= 8.0%). (10) Patients with poorly controlled hypertension (systolic blood pressure >= 160 mmHg or diastolicblood pressure >= 100 mmHg). (11) Patients with symptoms of dyspnea at rest. (12) Patients with pleural effusion, ascites, or cardiac effusion requ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year PFS rate from the secondary enrollment (all arms) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)2-year PFS rate after the secondary enrollment (each arm): Key Secondary End Point (2)Rate of disappearance of ESR1 mutations in ctDNA with FUL + ABE: Key Secondary End Point (3)PFS from the secondary enrollment (all arms and each arm) (4)PFS from FUL + ABE initiation (arm FUL + ABE, arm Re-AI + ABE, and both arms) (5)PFS with Re-AI + ABE (arm Re-AI + ABE) (6)Overall survival (OS) (all arms and each arm) (7)Response rate and disease control rate (all arms and each arm) (8)Safety (9)Protocol treatment compliance rate | — |
Contacts
Public ContactTetsuhiro Yoshinami
The University of Osaka Hospital
Outcome results
None listed