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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | Hormone Receptor Positive Breast Cancer |
| Drug: | Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Resistant |
Evidence:
Source:
Title:
Endocrine Therapy for Hormone Receptor-Positive Metastatic Breast Cancer
Excerpt:
CONTRADICTING EVIDENCE: Targeted Therapy: A nonsteroidal AI and palbociclib may be offered to postmenopausal women with treatment-naive HR-positive MBC, because progression-free survival (PFS) but not overall survival (OS) was improved compared with letrozole alone.
Secondary therapy:
Aromatase inhibitor
DOI:
10.1200/JCO.2016.67.1487
Excerpt:
Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:...in combination with an aromatase inhibitor…in combination with fulvestrant in women who have received prior endocrine therapy.
Source:
Title:
A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
Excerpt:
...Centrally confirmed hormone-receptor-positive (≥1% ER and/or PR positive stained cells) and HER2-normal (IHC score 0-1 or FISH negative (in-situ hybridization (ISH) ratio) ly confirmed for both sides....
Trial ID:
Source:
Title:
PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)
Excerpt:
...From a clinical point of view, the primary endpoint for this study is the PFS (progression-free survival) - defined as the period of time from randomization until objective tumor progression or death - assessed by RECIST criteria v.1.1, of continuation of palbociclib treatment combined with second-line endocrine therapy (letrozole or fulvestrant) versus endocrine therapy in pre- and post- menopausal women with HR-positive/HER2-negative ABC.`...
Trial ID:
More C2 evidence
Source:
Title:
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
Excerpt:
...- Female patients ≥ 18 years of age diagnosed with hormone receptor-positive/ human epidermal growth factor receptor 2- negative metastatic breast cancer undergoing treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane or anastrozole) or fulvestrant as first-line therapy, or in treatment with Palbociclib and fulvestrant as second-line or posterior-line therapy in the metastatic setting; may be using ovarian suppression if the patient is premenopausal....
Trial ID:
Source:
Title:
Impact of eHealth-support on Quality of Life in metastatic breast cancer patients treated with Palbociclib and endocrine therapy
Excerpt:
......
Trial ID:
Source:
Title:
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
Excerpt:
...Number of Participants According to the Starting Dose of Palbociclib`Duration of Treatment`Number of Participants Who Had Any Palbociclib Dose Reduction`Number of Participants Who Had Any Interruption in Palbociclib Treatment`Number of Participants Who Had Any Delays in Palbociclib Treatment`Number of Participants According to Reasons for Treatment Discontinuation`Number of Participants According to Reasons for Change in Treatment`Progression Free Survival`Objective Response Rate (ORR)`Number of Participants Who Died`Overall Survival (OS)`Number of Participants According to Biomarker Status`Number of Participants With Family History of Breast Cancer`Duration From Breast Cancer Diagnosis to Palbociclib Treatment`Number of Participants According to Stages of Breast Cancer`Number of Participants According to Node Status`Number of Participants According to Menopausal Status`Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)`Number of Participants According to Metastatic Sites`Number of Participants According to de Novo and Recurrent Disease`Number of Participants According to Therapies Received for Early Breast Cancer`Time Since End of Adjuvant Treatment`Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis`Duration of Supportive Treatments for ABC/MBC`Number of Participants According to Reasons for Regimen Change...
Trial ID:
Source:
Title:
A single-arm, open-label, phase II, multicenter clinical study of abeciclib in the treatment of recurrent or metastatic hormone receptor-positive breast cancer that has progressed after palbociclib therapy
Excerpt:
...Histologically confirmed histopathologically confirmed locally advanced or metastatic hormone receptor-positive (estrogen receptor ER and/or progesterone receptor PR-positive) and HER2-negative (human epidermal growth factor 2 ( HER2) expression deficiency), patients who are not suitable for surgical treatment; 2. ...
Trial ID:
Source:
Title:
Palbociclib plus letrozole for menopausal women with localized breast cancer
Excerpt:
...1.Female, age ≥18 years 2.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 3.Histologically confirmed adenocarcinoma of the breast (bilateral breast cancer allowed) 4.Breast cancer tumor removed by surgery 5.Hormone receptor positive: ER+ and/or PR+ by IHC (≥10%) 6.HER2-negative by IHC (score 0 or 1+) and/or DISH negative (HER2 copy number nopausal range 10.Adequate renal, hepatic, and hematopoietic functions as defined by the following criteria: -Absolute Neutrophil Count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L -Platelets ≥100,000/mm3 or ≥100 x 109/L -Hemoglobin ≥9 g/dL -Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) ≤2.5 x upper limit of normal (ULN) (4x if liver metastasis) -Alkaline phosphatase ≤2.5 x ULN -Total serum creatinine ≤1.5 x ULN or estimated creatinine clearance >60 mL/min as calculated using the method standard for the institution 11.Adequate cardiac functions, including: -12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention. ...
Trial ID:
Source:
Title:
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
Excerpt:
...Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer....
Trial ID:
Source:
Title:
Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer
Excerpt:
...Recurrent tumor must be hormone receptor positive:...
Trial ID:
Source:
Title:
Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)
Excerpt:
...- Patients must have histologically confirmed hormone receptor positive (ER and/or PR), HER2 negative, invasive breast cancer....
Trial ID:
Source:
Title:
Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
Excerpt:
...- Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer....
Trial ID:
Source:
Title:
Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
Excerpt:
...To determine the overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy in subjects with hormone receptor positive and Her-2/neu negative breast cancer`Overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy`To determine the rate of reduction of Ki67 index after 4 weeks of neoadjuvant Palbociclib and endocrine therapy`Rate of reduction of Ki67 index...
Trial ID:
Source:
Title:
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
Excerpt:
...Hormone-receptor-positive (HR+) disease, defined as estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+) 4....
Trial ID:
Source:
Title:
Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy
Excerpt:
...Histologically confirmed non-metastatic primary HR-positive/HER2 negative breast cancer with all the following characteristics:...
Trial ID:
Source:
Title:
Palbociclib With Everolimus + Exemestane In BC
Excerpt:
...- Participants with histologically or cytologically confirmed hormone receptor (HR)-positive, Her2-negative metastatic breast cancer....
Trial ID:
Source:
Title:
Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC
Excerpt:
...- Hormone receptor-positive [estrogen receptor (ER) and/or progesterone receptor (PR)] and HER2-negative...
Trial ID:
Source:
Title:
Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer
Excerpt:
...- Operable hormonal receptor (HR) positive (ER/PR greater than or equal to 10%), HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment and ovarian suppression; HR- positive and HER2-negative as determined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP ) guidelines....
Trial ID:
Source:
Title:
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Excerpt:
...Pathologically confirmed HR-positive/HER2-negative diagnosis....
Trial ID:
Source:
Title:
A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).
Excerpt:
...Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed)....
Trial ID:
Source:
Title:
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
Excerpt:
...The tumor must be hormone-receptor positive 7....
Trial ID:
Source:
Title:
Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer
Excerpt:
...- Patients with histological and imaging findings-confirmed hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer;...
Trial ID:
Source:
Title:
Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -
Excerpt:
......
Trial ID:
Source:
Title:
Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China
Excerpt:
...4) Pathological examination confirmed HR-positive, HER2-negative breast cancer patients with local recurrence or metastasis evidence....
Trial ID:
Source:
Title:
Efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor in hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer: a multi-center parallel-group randomized controlled trial
Excerpt:
...1 Patients with histological and imaging findings-confirmed hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer; 2 postmenopausal patients; 3 eligible patients receiving one or more treatment strategies who are followed-up in the center where they receive treatment; 4 provision of written informed consent....
Trial ID:
Source:
Title:
Palbociclib plus aromatase inhibitor/fulvestrant with ovarian function suppression versus docetaxel plus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative local recurrent or metastatic breast cancer: a multicentre, prospective, randomised, non-inferiority, phase 2 trial
Excerpt:
...1.Premenopausal women with histologically confirmed hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer,and ER >= 10% ,PR >= 10%. ...
Trial ID:
Source:
Title:
Efficacy and safety of intensive adjuvant treatment with a CDK4/6 inhibitor in non-pCR patients with HR-positive HER2-negative breast cancer after neoadjuvant chemotherapy: a prospective, multicenter, randomized, open-label phase II clinical study
Excerpt:
...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). ...
Trial ID:
Source:
Title:
Clinical trial in patients with advanced breast cancer (hormone receptor-positive, HER2-negative) receiving palbociclib and standard therapy with an aromatase inhibitor or fulvestrant after prior endocrine therapy.
Excerpt:
...- Patients with proven diagnosis of advanced adenocarcinoma of the breast (locally advanced, inoperable or metastatic disease).- Patients with hormone-receptor-positive (HR+) disease, defined as ER+ and/or PgR+ - Patients with human-epidermal-growth-factor-receptor-2-negative (HER2-) disease - Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist or postmenopausal status- Patients scheduled for palliative treatment with the combination of palbociclib and letrozole for first- or later-line, anastrozole for first-line, exemestane for first-line, or fulvestrant for first-or later-line after prior endocrine failure.- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2...
Trial ID:
Less C2 evidence
Source:
Title:
[Treatment of palbociclib in hormone receptor positive breast cancer: a real-world study and efficacy prediction model]
Published date:
04/23/2023
Excerpt:
CONTRADICTING EVIDENCE: We retrospectively analyzed data from 66 HR-positive metastatic breast cancer patients treated with palbociclib and endocrine therapy...The overall response rate was 14.3% (95% CI: 6.7%, 25.4%) and clinical benefit rate was 58.7% (95% CI: 45.6%, 71.0%)....Our report indicates that palbociclib combined with endocrine therapy for HR-positive recurrent metastatic breast cancer is effective and safe...
Secondary therapy:
Hormone Therapy
DOI:
10.3760/cma.j.cn112152-20210811-00606
Source:
Title:
32P - The neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios predict efficacy of CDK 4/6 inhibitors in women with hormone receptor-positive/HER2-negative advanced breast cancer
Published date:
05/23/2020
Excerpt:
This is the first study to show a significant association between high NLR or PLR values, as measured during CDK 4/6 inhibitor treatment, and lower PFS in HR+ aBC pts.
