NCT04526028
Unknown
Not Applicable
Evaluate Efficacy and Safety of CDK4/6 Inhibitor Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Female Patients With HR+/HER2- Advanced Breast Cancer: A Real-world Multicenter Observational Study in China
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country612 target enrollmentStarted: September 13, 2019Last updated:
Overview
- Phase
- Not Applicable
- Enrollment
- 612
- Locations
- 1
- Primary Endpoint
- progression-free survival (PFS)
Overview
Brief Summary
The purpose of this study is to evaluate efficacy and safety of CDK4/6 inhibitor Palbociclib in combination with Fulvestrant versus Fulvestrant in female patients with HR+/HER2- advanced breast cancer in a real world setting in China. Primary study endpoint: progression-free survival (PFS). Secondary study endpoints: overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), objective response duration (DOR) and safety.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients with advanced breast cancer aged 18 years or older.
- •Meet the inclusion criteria (2a) or the inclusion criteria (2b). Patients who met inclusion criteria (2a) were included in cohort A, and patients who met inclusion criteria (2b) were included in cohort B.
- •(2a) Meet any of the following criteria: a) recurrence and metastasis of evidence of imaging progression for more than 1 year after completion of endocrine neoadjuvant or adjuvant therapy and no endocrine therapy for recurrent metastatic disease; b) A primary metastatic disease has occurred and no previous endocrine therapy has been received.
- •(2b) Meet any of the following criteria: a) previous endocrine-assisted treatment completed 2 years and above, and recurrence and metastasis of evidence of imaging progression during treatment, and no subsequent endocrine therapy after progression; b) completion of adjuvant endocrine After treatment, recurrence and metastasis of evidence of imaging progression occurred within 1 year, and no subsequent endocrine therapy was received after progression; c) recurrence and metastasis occurred after more than 1 year after completion of adjuvant endocrine therapy, and then received anti-estrogen drugs or aromatase inhibitors as evidence of disease progression after first-line endocrine therapy and evidence of imaging progression, patients may not have more than 1 line of endocrine therapy for recurrent metastatic disease; d) primary metastatic disease, and subsequent anti-acceptance Estrogen drugs or aromatase inhibitors as a first-line metastatic disease after endocrine therapy disease progression and evidence of imaging progression, patients can not receive more than 1 line of endocrine therapy for metastatic disease.
- •Postmenopausal or premenopausal/perimmenopausal women can be enrolled. In postmenopausal state, defined as meeting at least one of the following criteria: previous bilateral ovarian surgery; age≥60 years; age \<60 years, menopause for at least 12 months (not because of chemotherapy, tamoxifen, toremifene or ovarian suppression) and follicle stimulating hormone (FSH) and estrogen levels are in the postmenopausal range.
- •Premenopausal or perimenopausal women can also be enrolled, but must be willing to receive LHRHa treatment during the study.
- •Pathological examination confirmed HR-positive, HER2-negative breast cancer patients with local recurrence or metastasis evidence.
- •ER-positive and/or PR-positive is defined as: positively stained tumor cells account for ≥1% of all tumor cells (confirmed by the investigator at the test center);
- •HER2-negative is defined as: standard immunohistochemistry (IHC) detection is 0/1+; ISH detection: the HER2/CEP17 ratio is less than 2.0 or the HER2 gene copy number is less than 4 (confirmed by the researcher at the test center).
- •According to the RECIST1.1 standard, patients must have: a) measurable lesions; b) unmeasurable osteolytic or mixed (osteolytic + osteogenic) bone lesions in the absence of measurable lesions.
Exclusion Criteria
- •HER2 overexpression or gene amplification, such as immunohistochemical score 3+ or fluorescent in situ hybridization.
- •Female patients during pregnancy or lactation.
- •Patients who are considered unsuitable for inclusion by the investigator.
Arms & Interventions
Palbociclib combined with Fulvestrant
Intervention: Fulvestrant Injectable Product (Drug)
Palbociclib combined with Fulvestrant
Intervention: Palbociclib (Drug)
Fulvestrant
Intervention: Fulvestrant Injectable Product (Drug)
Outcomes
Primary Outcomes
progression-free survival (PFS)
Time Frame: 41 months
To compare the progression-free survival for patients receiving CDK4/6 Inhibitor Palbociclib in Combination with Fulvestrant Versus Fulvestrant
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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