Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant (NCT02894398) | Clinical Trial Compass
CompletedPhase 2
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
Germany388 participantsStarted 2016-09-06
Plain-language summary
The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline therapy in combination with palbociclib (Ibrance)
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Personally signed written informed consent prior to beginning protocol specific procedures, including expected cooperation of the patient for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
✓. Women with proven diagnosis of advanced, defined as locally advanced inoperable or metastatic, adenocarcinoma of the breast
✓. Hormone-receptor-positive (HR+) disease, defined as estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+)
✓. Human epidermal growth factor receptor 2-negative (HER2-) disease (HER2 neg/+ or HER2++ with CISH/FISH neg.)
✓. Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist / ovarian ablation or postmenopausal status
✓. Age ≥18 years
✓. Measurable disease as per Response Evaluation Criteria in Solid Tumors \[RECIST\] or bone-only disease
✓. Patients scheduled for palliative treatment with an combination partner for first- or later-line
Exclusion criteria
✕. Prior treatment with any CDK4/6 inhibitor
✕. Prior adjuvant therapy with the respective endocrine combination partner if last intake \<12 months prior to entering the study
✕. Prior palliative therapy with the respective endocrine combination partner
What they're measuring
1
Clinical Benefit Rate (CBR)
Timeframe: 24 weeks after first administration of Palbociclib in combination with AI / fulvestrant