^
Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
HER2-Negative and postmenopausal or premenopausal receiving ovarian ablation or suppression: Preferred Regimens: Second and subsequent line therapy: Fulvestrant + CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) if CDK4/6 inhibitor not previously used (category 1)....Preferred Regimens: First-Line therapy, Aromatase inhibitor + CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) (category 1).
Secondary therapy:
fulvestrant; Aromatase inhibitor
Source:
Title:
Impact of eHealth-support on Quality of Life in metastatic breast cancer patients treated with Palbociclib and endocrine therapy
Excerpt:
...The tumor has to be HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by ISH.8. ...
Trial ID:
Source:
Title:
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
Excerpt:
......
Trial ID:
More C2 evidence
Source:
Title:
Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
Excerpt:
...- ER positive tumor and HER2-negative tumor, as assessed locally...
Trial ID:
Source:
Title:
Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
Excerpt:
...- Newly diagnosed invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR-positive breast cancer is defined by > 10% staining by immunohistochemistry...
Trial ID:
Source:
Title:
Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy
Excerpt:
...- Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is...
Trial ID:
Source:
Title:
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
Excerpt:
......
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:
A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC
Excerpt:
...Patient has HER2-negative breast cancer with IHC and/or FISH (or SISH, CISH) Patient has ER positive and/or PgR positive breast cancer by local laboratory testing 5....
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:
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:
A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with ER+ primary breast cancer.
Excerpt:
...HER2 negativity will be defined as per the 2013 ASCO/CAP guidelines as follows:i. ...
Trial ID:
Source:
Title:
NEO21-RS: A prospective study of the outcomes following 21-gene recurrence score directed neoadjuvant therapy in ER-positive, HER2-negative breast cancer patients
Excerpt:
...• 18 years of age or older• Histologically confirmed invasive breast cancer• ER positive (Allred ≥3) • HER2 negative per the 2013 ASCO/CAP guidelines• Axillary node negative or positive• Tumour measuring ≥15mm in longest diameter as measured clinically or radiologically* or any size tumour with axillary node involvement • Candidate for neoadjuvant endocrine therapy or chemotherapy • Pre- or postmenopausal womenPostmenopausal status will be defined by the presence of any one of the following criteria:≥55 years of age with an intact uterus and amenorrhoea ≥12 months at the time of diagnosis 18 years with prior hysterectomy with intact ovaries and with a documented or current FSH and oestradiol level within the postmenopausal range (as per local institutional/laboratory standard)>18 years with prior bilateral oophorectomy• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2• Adequate bone marrow function defined by Hb≥10 g/dl, ANC >1.5 x109, PLT≥100 x109/L. ...
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:
Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women
Excerpt:
...- Negative HER-2 receptor...
Trial ID:
Source:
Title:
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
Excerpt:
...- Metastatic estrogen receptor positive (ER+) or progesterone receptor positive (PR+), Her2/neu negative breast cancer patients with imaging confirming bone metastasis within 60 days of radiation simulation...
Trial ID:
Source:
Title:
Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant
Excerpt:
...- Her-2 negative (score 0 or 1 by immunochemistry), FISH (fluorescence in situ hybridization) negative if IHC (immuno-histochemistry) score 2)....
Trial ID:
Source:
Title:
A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer
Excerpt:
...- Operable ER-positive/HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment....
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:
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:
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 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:
Source:
Title:
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
Excerpt:
......
Trial ID:
Source:
Title:
A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs
Excerpt:
......
Trial ID:
Source:
Title:
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
Excerpt:
...- Documentation of HER2-negative tumor based on most recent tumor biopsy....
Trial ID:
Source:
Title:
Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer
Excerpt:
...Recurrent tumor must be HER2-negative (0, 1+, 2+ by IHC and/or ISH/FISH...
Trial ID:
Source:
Title:
Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer
Excerpt:
...- Diagnosis of estrogen positive breast cancer, estrogen receptor-positive and HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria...
Trial ID:
Source:
Title:
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
Excerpt:
......
Trial ID:
Source:
Title:
PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
Excerpt:
......
Trial ID:
Source:
Title:
Prediction of Treatment Efficacy of the Combination of Palbociclib/(Letrozole or Anastrozole) in First Line Metastatic Women With Luminal, HER2 Negative Advanced Breast Cancer, Using Infrared Laser Spectroscopy Analysis on Liquid Biopsies.
Excerpt:
...HER2 negative (score 0 or 1 by immunochemistry), FISH negative if IHC score 2....
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:
HR+/HER2- Advanced Breast Cancer and Endocrine Resistance
Excerpt:
...Known HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+....
Trial ID:
Source:
Title:
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
Excerpt:
......
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:
Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
Excerpt:
...- ER-positive and/or PR-positive, HER2-negative tumor -...
Trial ID:
Source:
Title:
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
Excerpt:
......
Trial ID:
Source:
Title:
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
Excerpt:
......
Trial ID:
Source:
Title:
Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
Excerpt:
...- Histologically confirmed adenocarcinoma of the breast, with ER positive and HER2 negative status based on local testing on most recent pathological tumour specimen....
Trial ID:
Source:
Title:
PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
Excerpt:
...- Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2 negative (0 or 1+ by IHC or FISH negative for amplification) breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node....
Trial ID:
Source:
Title:
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
Excerpt:
...- Histologic confirmation from the pre-registration biopsy of either locally advanced or metastatic breast cancer that is ER-positive and HER2 -negative -...
Trial ID:
Source:
Title:
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Excerpt:
...Estrogen Receptor (ER)-positive and HER2-negative breast cancer....
Trial ID:
Source:
Title:
A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC.
Excerpt:
...HER-2 negative....
Trial ID:
Source:
Title:
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
Excerpt:
...- Hormonal receptor-positive, HER2 negative....
Trial ID:
Source:
Title:
Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer
Excerpt:
...- Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER >1%, PR >1%), HER2 negative breast cancer....
Trial ID:
Source:
Title:
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
Excerpt:
...Estrogen Receptor (ER)-positive and HER2-negative 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:
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region
Excerpt:
......
Trial ID:
Source:
Title:
Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period
Excerpt:
...Scoring of 0 or 1+ for HER2 protein expression by a validated immunohistochemistry assay or +1/+2 with negative HER2 amplification FISH/ISH ratio lower than 1.8 or HER2 gene copy less than 4.0....
Trial ID:
Source:
Title:
Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer (NeoRHEA)
Excerpt:
...Histological diagnosis of breast adenocarcinoma that is estrogen receptor-positive, and HER2- negative as per the updated American Society of Clinical Oncology (ASCO)...
Trial ID:
Source:
Title:
Patterns of Prescribing and Monitoring of Palbociclib
Excerpt:
......
Trial ID:
Source:
Title:
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
Excerpt:
...Human epidermal growth factor receptor 2-negative (HER2-) disease (HER2 neg/+ or HER2++ with CISH/FISH neg.) 5....
Trial ID:
Source:
Title:
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer
Excerpt:
...Negative HER-2 receptor (based on 2018 ASCO/CAP Guideline) 6....
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:
Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone
Excerpt:
...HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, fluorescence in situ hybridization [FISH] positive/amplified, positive...
Trial ID:
Source:
Title:
Palbociclib and FES PET
Excerpt:
...Patients with ER positive (i.e. >1% staining), HER2 negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy) 2....
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:
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
Excerpt:
...Estrogen Receptor (ER)-positive and HER2-negative breast cancer. ...
Trial ID:
Source:
Title:
Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer
Excerpt:
...Documented histologically confirmed breast cancer with ER and/or PgR positive and HER2 negative status....
Trial ID:
Source:
Title:
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy
Excerpt:
...HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis 5....
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 Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women
Excerpt:
...HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish 8....
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:
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
Excerpt:
...- HER2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines)....
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 HER2-negative defined as either HER2 immunohistochemistry Score 0 or 1+ or as HER2-negative by in situ hybridization.....
Trial ID:
Source:
Title:
Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
Excerpt:
...estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required...
Trial ID:
Source:
Title:
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
Excerpt:
...HER2-negative breast cancer based on local laboratory results (test to be used as per local practice) 4....
Trial ID:
Source:
Title:
PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer
Excerpt:
...HER2 negative breast cancer as confirmed by IHC, SISH or FISH....
Trial ID:
Source:
Title:
Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
Excerpt:
...Documented HER2 negative breast cancer based on local laboratory determination on most recent tumor biopsy....
Trial ID:
Source:
Title:
Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -
Excerpt:
...Patients with HER2-negative breast cancer through in situ hybridization test (fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], or silver enhanced in situ hybridization [SISH]) or negative immunohistochemical status of 0, 1+, or 2+....
Trial ID:
Source:
Title:
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
Excerpt:
...- In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease)...
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:
High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)
Excerpt:
...Patient with histologically confirmed HER2-negative breast cancer 7....
Trial ID:
Source:
Title:
Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy
Excerpt:
...Histological confirmation of ER and/or PgR ≥ 1% and HER2 negative breast cancer (IHC status 0, 1+, 2+ and FISH...
Trial ID:
Source:
Title:
Fulvestrant (F)+Placebo vs F+Palbociclib First Line for Postmenopausal Hormone Receptor+ Advanced Breast Cancer
Excerpt:
...Documented HER2-negative tumour based on central testing on the most recent tumour biopsy....
Trial ID:
Source:
Title:
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
Excerpt:
...- Inoperable estrogen receptor positive and HER2 negative breast cancer....
Trial ID:
Source:
Title:
Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
Excerpt:
...- HER2-negative tumor based on local laboratory results...
Trial ID:
Source:
Title:
The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer
Excerpt:
...HER2 negative (HER2+/- by IHC or FISH-) 5....
Trial ID:
Source:
Title:
A Biomarker Study of Palbociclib + Fulvestrant for Second, and Third Line of Postmenopausal Women With hr+/her2- Advanced Breast Cancer
Excerpt:
......
Trial ID:
Source:
Title:
To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy
Excerpt:
...- HER2 negative breast cancer by FISH or IHC...
Trial ID:
Source:
Title:
Early identification of patients who benefit from palbociclib in addition to letrozole
Excerpt:
...Patients with ER positive (i.e. >1% staining), HER2 negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy)2. ...
Trial ID:
Source:
Title:
A Phase II study of post-operative palbociclib as an alternative to chemotherapy in older patients with localized breast cancer at high risk of relapse
Excerpt:
...- Women or men with stage II or stage III, early invasive breast cancer according to the UICC 8th edition for TNM classification - Histologically confirmed ER+ (at least 10 % of cells staining positive for ER), HER-2 negative, early invasive breast cancer based on results of local pathology. ...
Trial ID:
Less C2 evidence
Source:
Title:
Proton pump inhibitors may reduce the efficacy of ribociclib and palbociclib in metastatic breast cancer patients based on an observational study
Published date:
05/07/2022
Excerpt:
We enrolled hormone receptor-positive, HER2-negative mBC patients treated with endocrine treatment (letrozole or fulvestrant) combined palbociclib or ribociclib alone or with PPI accompanying our observational study....In the palbociclib group, the PFS of the patients using PPIs was shorter than the PFS of the patients not using (13.04 months vs. unreachable, p < 0.001)....In the ribociclib group, the PFS of the patients using PPIs was shorter than the PFS of the patients not using (12.64 months vs. unreachable, p = 0.003)....Our study demonstrated that concomitant usage of PPIs was associated with shorter PFS in mBC treated with both ribociclib and especially palbociclib.
Secondary therapy:
Proton pump inhibitor + fulvestrant; Proton pump inhibitor + letrozole
DOI:
10.1186/s12885-022-09624-y
Source:
Title:
Survival outcomes after neoadjuvant letrozole and palbociclib versus third generation chemotherapy for patients with high-risk oestrogen receptor-positive HER2-negative breast cancer
Published date:
03/22/2022
Excerpt:
Twenty-three of the 53 patients in the letrozole-palbociclib arm received postoperative adjuvant chemotherapy….The 40 months PFS rate was 86.7% [95%CI 78.0–96.4] and 89.9% [95%CI 81.8–98.7] in letrozole-palbociclib and control arms, respectively….NEOPAL suggests that a neoadjuvant letrozole-palbociclib strategy may allow sparing chemotherapy in some patients with luminal breast cancer while allowing good long-term outcomes.
DOI:
https://doi.org/10.1016/j.ejca.2022.01.014
Trial ID:
Source:
Title:
Palbociclib with letrozole as second-line neo-systemic therapy after failure of neo-adjuvant chemotherapy for luminal type breast cancer: A case report
Published date:
04/09/2021
Excerpt:
A 50-year-old female patient visited our hospital with palpable lump in the right breast....Palbociclib with letrozole was administered as second neo-systemic therapy for 10 months....reduce the size of the tumor and increase the likelihood of avoiding the side effects of surgery. Palbociclib with letrozole may be a good treatment in the preoperative stage for luminal breast cancer that is resistant to chemotherapy.
Secondary therapy:
letrozole
DOI:
10.1097/MD.0000000000025175
