Breast Cancer
Conditions
Interventions
Group 1:palbociclib plus aromatase inhibitor/fulvestrant with ovarian function suppression
Group 2:docetaxel plus capecitabine and sequential capecitabine
Sponsors
The Second Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Premenopausal women with histologically confirmed hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer,and ER >= 10% ,PR >= 10%. 2.Recurrent or metastatic breast cancer which is not suitable for radical resection or radiotherapy. 3.Patient must meet one of the following criterianot receive adjuvant endocrine therapy or complete adjuvant endocrine therapy for more than 1 year while disease progressioncomplete adjuvant endocrine therapy for less than 1 year or receive adjuvant endocrine therapy for more than 2 years while disease progressionadjuvant endocrine therapy with an aromatase inhibitor is excluded ;Primary metastatic breast cancer. 4.Patient must meet one of the following criteria:not receive neoadjuvant or adjuvant chemotherapy contained Taxanesstop neoadjuvant or adjuvant chemotherapy contained Taxanes for at least 12 months while disease progression. 5.No previous anticancer treatment in the context of advanced disease, such as endocrine therapy, chemotherapy, biological agents or targeted therapy. At least 2 weeks prior to randomization, the use of traditional Chinese medicine for anticancer treatment must be discontinued. 6.Premenopausal status defined as having had the most recent menstrual period within the past 12 months in any patients; for patients on tamoxifen, a period within the previous 3 months, a plasma oestradiol concentration higher than 10 pg/mL, follicle-stimulating hormone (FSH) concentration of at least 40 IU/L, or plasma oestradiol and FSH concentrations within the laboratory-defined premenopausal range; or in patients with chemotherapy-induced amenorrhoea, a plasma oestradiol concentration higher than 10 pg/mL, FSH concentration of at least 40 IU/L, or plasma oestradiol and FSH concentrations within the laboratory-defined premenopausal range. 7.Eligible patients must have had measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), Single bone metastasis or only lymph nodes metastasis is excluded. 8.Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. 9.Adequate bone marrow, liver, and renal function. 10.Female aged 18 years or older. 11.Randomization 2 weeks after discontinuation of local radiation therapy for palliative or osteolytic lesions at risk of fracture , and recovery from the acute effects of the treatment (toxicity remission to baseline or at least grade 1 level), with the exception of residual effects of hair loss or peripheral neuropathy. 12.Able to swallow capsules and tablets. 13.Intend to participate in study process and to follow the study procedure and sign informed consen1.
Exclusion criteria
Exclusion criteria: 1.Postmenopausal status. 2.Patients with visceral crisis. 3.Symptomatic central nervous system (CNS) metastases or meningeal metastases. 4.Receive chemotherapy or endocrine treatment in the context of advanced disease. 5.Previous treatment with fulvestrant, or capecitabine. or CDK4/6 inhibitors. 6.Bisphosphonates were used during the first 7 days of randomization. 7.Participate in another clinical trial within 4 weeks (or 3 months in the case of a monoclonal drug clinical trial) prior to study inclusion. 8.Pregnant and lactation patients. 9.Severe medical conditions such as serious uncontrolled intercurrent infections and serious intercurrent medical or psychiatric illness. 10.Undergone major surgery within 14 days prior to randomization. 11.Any other history of cancer except cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin which has been treated radically. 12.Any history of study drug hypersensitivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;CBR;safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactMan Li
The Second Affiliated Hospital of Dalian Medical University
Outcome results
None listed