Advanced Breast Cancer, Female Breast Cancer
Conditions
Keywords
HR receptor positive HER2 receptor negative, Combined with flulvestrone ± goseraline
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase iii clinical study evaluating the efficacy and safety of FCN- 437c in combination with fluvestrant ± goseraline versus placebo in combination with fluvestrant ± goseraline in women with HR+ and HER2- advanced breast cancer.
Interventions
DRUGFCN-437c,Fulvestrant,Goserelin acetate
FCN-437c：available in 25mg and 100mg capsules for oral administration on an empty stomach. 200mg once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment until progressive disease。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles ； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。
DRUGPlacebo,Fulvestrant,Goserelin acetate
Placebo：available in 25mg and 100mg capsules, and is administered in the same way as FCN-437c。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。
Sponsors
Ahon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following conditions: 1. Female advanced breast cancer patients aged ≥18 years, diagnosed as HR+ HER2-. HR+ positive is defined as：Histological and/or cytological confirmed ER+, PR + or -, defined as immunohistochemistry showing positive nuclear staining of estrogen/progesterone receptor tumor cells≥1%； HER2-negative is defined as：Histological and/or cytological confirmed HER2-， defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+,the ISH test result must be negative。 2. Arbitrary menopausal status.Postmenopausal female is defined as: After bilateral oophorectomy ; Age≥60 years Age\<60 years and menopause for more than 1 year without chemotherapy and treatment with tamoxifen, toremifene and ovarian function suppression, while blood FSH and estradiol levels meet the postmenopausal range and for postmenopausal patients who are taking tamoxifen or toremifene and who are younger than 60 years old, continuous detection of serum FSH and estradiol levels must meet the postmenopausal range.. 3. Previous treatment criteria: Second-line and above patients can be included in the group。 4. Previous treatment criteria: Second-line and above patients can be enrolled. Eastern cooperative oncology group (ECOG) 0-1。 5. According to the RECIST 1.1 criteria, patients must have at least one measurable lesion, or patients with only bone metastases, if no measurable lesions are present, must have at least one bone lesion predominantly lytic. Note:If the lesion has received radiotherapy or other locoregional treatment, there must be imaging evidence of disease progression in the lesion after completion of treatment, and the lesion can be considered as a measurable lesion. For patients with no measurable lesion and only one osteolytic lesion, if the lesion was previously treated with radiotherapy, imaging evidence is needed to show the progression of bone lesions after radiotherapy.。 6. Life expectancy is not less than 12 weeks; 7. Adequate bone marrow and organ function: 1. Absolute neutrophil count (ANC) ≥1.5 x 109/L 2. Hemoglobin ≥90 g/dL(no red blood cell infusion within 14 days before randomization) 3. Platelet count ≥90 x 109/L 4. Total serum bilirubin ≤ 1.5 X upper limit of normal (ULN) , total serum bilirubin≤3 x ULN in patients with Gilbert syndrome; 5. Aspartate aminotransferase (AST)and alanine aminotransferase (ALT) ≤2.5x ULN; for patients with liver metastases,both AST and ALT ≤5× ULN; 6. Creatinine \<1.5 × ULN or creatinine clearance≥50 mL / min\[Ccr = ((140- age) ×body weight (kg)) / (72× Scr (mg / dl)) or Ccr = ((140-age)× body weight (kg)) / (0.818× Scr (umol / L)) Note: Females were calculated ×0.85\] 7. QTcF \< 470 ms ； 8. The patient is willing and able to comply with planned visits, treatment plans, laboratory examinations, and other trial procedures。 9. The patient is fully aware of the study and has signed an informed consent form (ICF); 10. For perimenopausal/premenopausal patients only: a high-efficiency contraceptive method with a failure rate of less than 1% per year must be used with a partner throughout the study period and for at least 90 days after discontinuation.
Exclusion criteria
Patients who meet any of the following conditions are not allowed to enter this clinical study： 1. The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS is determined by the IRC | 2 years | Progression-free survival is determined by the IRC according to the RECIST version 1.1 |
Countries
China
Contacts
Primary ContactXiaoran Yang
Outcome results
None listed