Breast Cancer
Conditions
Interventions
Experimental group:standard endocrine + palbociclib 1 year
Control group:Standard endocrine therapy for 1 year+Capecitabine 1000 mg/m2, bid D1-D14
Sponsors
Changhai Hospital, Navy Medical University, Shanghai
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained from patients before enrollment, including the expected cooperation during treatment and follow-up, which should be recorded according to local regulations. 2. In the core biopsy before and after the NAC, formalin-fixed paraffin embedding (15 white sections and 1 HE staining section) tissues and postoperative pathological specimens (5 non-DCIS white sections and 1 HE staining section) are provided. In special cases, at least one white section and HE staining section will be used to confirm the status of hormone receptor and HER2 and postoperative status of non-pCR. 3. The tumor must be histologically diagnosed as unilateral or bilateral primary infiltrating carcinoma of the breast. 4. Residual invasive disease in the breast or as residual lymph node infiltration after neoadjuvant therapy. 5. Evaluation of the centrally-confirmed positive hormone receptor (>= 10% ER) and normal HER2 (IHC score 0-1 or FISH negative (in situ hybridization (ISH) ratio). 6. Female patients, aged between 18 and 70 years old (18 years old included) 70 years old, with expected overall survival > 12 months. 7. The tumor must be examined by hollow needle puncture or ultrasound-located minimally invasive biopsy, diagnosed as unilateral primary infiltrating breast carcinoma at the clinical staging of ct1-4/n0-3/M0 (except ct1a-b /N0) by histopathology. HR+/HER2-, Ki67 >= 30%, and NAC >= 4 cycles for breast cancer including four cycles of taxonomic chemotherapy with residual invasive carcinoma of the breast or axillary lymph nodes (non-pCR) will be randomly assigned within 12 weeks postoperatively. 8. Patients must have received NAC for not less than 4 courses (three weeks every course). The chemotherapy regimen, which should include anthracyclines and/or taxanes, is designed by the attending physician. The result of the postoperative pathological evaluation must satisfy that the primary lesion is non-pCR (MP grade 1-4), or the lymph node is still positive. 9. Patients must undergo modified radical mastectomy or breast-conserving radical mastectomy after NAC. The standard chemotherapy course must be finished postoperatively. 10. HR-positive HER2-negative type is defined as ER-positive rate of immunohistochemical staining of tumor cells > 10%; PR-positive is defined as the PR-positive rate of immunohistochemical staining of tumor cells is > 10%; HER2-negative is defined as HER2 immunohistochemical 0-1+ or HER2 2+, but is negative by FISH test (no amplification). 11. No concurrent malignant tumors (except for the controlled carcinoma in situ of the cervix or basal cell carcinoma of the skin) 12. Physical examination, imaging, and laboratory examination should be performed two weeks before randomization with no evidence of metastasis or recurrence by standard clinical practice guidelines; EC0G score 0-1; (1) white blood cell count >= 3.5 x 10^9/L or neutrophil count >= 1.5 x 10^9/L, and blood platelet count >= 100 x 10^9/L; (2) AST/SGOT or ALT/AGPT < 1.5 times of upper limit of normal (ULN); (3) serum creatinine <= 110 µmol/L, and urea nitrogen <= 7.l mmol/L; (4) fertile women willing to take contraceptive measures in the trial: serum or urine pregnancy test is negative 7 days before administration.
Exclusion criteria
Exclusion criteria: 1. Any previous (ipsilateral or contralateral) breast cancer history other than LCIS; 2. Any distant metastasis; 3. Patients with in situ carcinoma reaching pCR and pN0 after NAC; 4. Patients with previous malignant tumors (except basal cell carcinoma of the skin and carcinoma in situ of the cervix); 5. Patients enrolled in other clinical trials 6. Patients with serious systemic disease and/or uncontrolled infection; 7. Patients with uncontrolled lung disease, severe infection, active digestive tract ulcer needing treatment, coagulation disorders, severe uncontrolled diabetes, connective tissue disease or bone marrow dysfunction, and incapable of tolerating related treatment; 8. Severe cardiovascular and cerebrovascular diseases (e.g., unstable angina pectoris, chronic heart failure, uncontrolled hypertension >150/90 mmHg, myocardial infarction or cerebrovascular accident) six months before randomization; 9. Any history of a severe allergy to any kind of the drugs in the treatment; 10. Women of childbearing age refusing contraception during treatment and within eight weeks after treatment; 11. Pregnant and lactating women; 12. Positive pregnancy test before drug use after enrollment; 13. Mental illness, cognitive disorder, inability to understand the study protocol and side effects, and complete the protocol and follow-up (systematic evaluation is required before enrollment). 14. Without personal freedom and independent capacity for civil conduct. 15.Patients receiving Cdk4/6 inhibitor medication during the last two months; 16.HER2 overexpression or gene amplification, such as an immunohistochemical score of 3+ or positive fluorescence in situ hybridization; 17.Pregnant or lactating female patients; 18. Known severe hypersensitivity to palbociclib or palbociclib/placebo or endocrine therapy; 19. Insufficiency of organ function before randomization, including hemoglobin 1.5 x ULN; Alkaline phosphatase > 2.5 x ULN, total serum bilirubin > 1.25 x ULN; Serum creatinine > 1.25 x ULN, uncorrectable electrolyte disturbance (e.g., hypocalcemia, hypokalemia, hypomagnesemia); 20. If any of the following conditions occurs 6 months before randomization: myocardial infarction, severe/unstable angina, persistent arrhythmias in patients undergoing neoadjuvant therapy, atrial fibrillation in any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, including a cerebrovascular accident with a transient ischemic attack or symptomatic pulmonary embolism; 21. Active inflammatory bowel diseases or chronic diarrhea, short bowel syndromes or any upper gastrointestinal surgery, including gastrectomy; 22. Preexisting malignancy (including invasive or ductal carcinoma in situ) within the first 5 years before randomization, except for treated basal cell carcinoma and carcinoma in situ of the cervix; 23. Current severe acute or uncontrollable chronic systemic diseases (such as diabetes) or psychiatric or laboratory abnormalities that may increase the risk associated with research involvement or research product management, or may interfere the study findings, leading to patients being unsuitable to participate in the study; 24. Recent (last year) or active suicidal behavior; 25. Pregnancy or lactation. Women in fertility must take appropriate non-hormonal contraceptive measures (barrier method, intrauterine contraceptive device, sterilization) during treatment and within 90 days after discontinuation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| invasive disease free survival, iDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| breast cancer-free interval, BCFI;breast cancer-specific survival, BCSS;overall surviva,OS; | — |
Countries
China
Contacts
Public ContactSheng Yuan
Changhai Hospital, Navy Medical University
Outcome results
None listed