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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | Estrogen Receptor Positive Breast Cancer |
| Drug: | Ibrance (palbociclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Early Switch to Fulvestrant Plus Palbociclib Improves Outcomes in ESR1-Mutated, Estrogen Receptor-Positive Metastatic Breast Cancer
Published date:
03/28/2022
Excerpt:
For patients with estrogen receptor-positive metastatic breast cancer who are treated with palbociclib plus an aromatase inhibitor, the strategy of switching to palbociclib plus fulvestrant upon detection of a resistance mutation more than doubled progression-free survival, according to results from the phase III PADA-1 trial.
Secondary therapy:
fulvestrant
DOI:
10.1093/oncolo/oyac016
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 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:
More C2 evidence
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 Versus Epirubicin + Cyclophosphamide and Sequential Docetaxel as Neoadjuvant Chemotherapy
Excerpt:
...- pathological examination confirms estrogen receptor positive, and Ki67 < 30% in breast cancer patients;...
Trial ID:
Source:
Title:
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
Excerpt:
...ER positive metastatic breast tumors (data now shows all to be Rb positive.) B....
Trial ID:
Source:
Title:
Palbociclib combined with letrozole versus epirubicin combined with cyclophosphamide and sequential docetaxel as neoadjuvant chemotherapy for inoperable postmenopausal estrogen receptor-positive breast cancer with low Ki67 expression: a prospective randomized controlled double-blind phase IV trial
Excerpt:
...pathological examination confirms estrogen receptor positive, and Ki67 < 30% in breast cancer patients; 2. ...
Trial ID:
Source:
Title:
A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Excerpt:
...or metastatic disease, both progressing after at least 6 months of hormonal therapy for estrogen receptor (ER) positive breast cancer...
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 <55 years with no menses for at least 12 months prior to study entry and documented or current FSH and oestradiol levels within the postmenopausal range (as per local institutional/laboratory standard>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:
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:
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:
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:
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:
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:
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:
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
Excerpt:
...Estrogen Receptor (ER)-positive and HER2-negative breast cancer. ...
Trial ID:
Less C2 evidence
Source:
Title:
Selective Androgen Receptor Modulators in combination with CDK4/6 inhibitors demonstrate anti-cancer activity in preclinical treatment resistant ER+AR+ breast cancer models
Published date:
11/22/2022
Excerpt:
...enobosarm or DHT and palbociclib treatment were evaluated in vivo using endocrine and CDK4/6i resistant ER+ patient derived xenograft models (PDX) and cell line xenograft models….growth inhibition was more potent and durable in combination with a CDK4/6i.
Secondary therapy:
enobosarm
Source:
Title:
The Combination of the CDK4/6 Inhibitor, Palbociclib, With the Vitamin D 3 Analog, Inecalcitol, Has Potent In Vitro and In Vivo Anticancer Effects in Hormone-Sensitive Breast Cancer, But Has a More Limited Effect in Triple-Negative Breast Cancer
Published date:
06/17/2022
Excerpt:
we evaluated if the combination of the potent vitamin D3 analog, inecalcitol, with a selective CDK4/6 inhibitor, palbociclib, enhanced the antiproliferative effects of both single compounds in hormone-sensitive (ER+) BC, for which palbociclib treatment is already approved, but also in triple-negative BC (TNBC). Inecalcitol and palbociclib combination treatment decreased cell proliferation in both ER+ (T47D-MCF7) and TNBC (BT20-HCC1143-Hs578T) cells, with a more pronounced antiproliferative effect in the former.
Secondary therapy:
TX-522
DOI:
10.3389/fendo.2022.886238
Source:
Title:
6280 / 15 - CDK4/6 inhibitor-mediatated radiosensitization of estrogen receptor positive breast cancer
Published date:
05/15/2020
Excerpt:
Palbociclib significantly radiosensitized ER+ cell lines at concentrations at or below the IC50 value in clonogenic survival assays (MCF-7 rER: 1.22-1.52, T47D rER: 1.23-1.50) and led to a decrease in the surviving fraction of cells at 2 Gy (p < 0.001). Similar results were observed in ribociclib- (rER: 1.08 - 1.68) and abemaciclib-treated (rER: 1.19 - 2.05) cells....Our data suggests that CDK4/6 inhibitor-mediated radiosensitization may be effective in ER+ breast cancers prior to the development of CDK4/6 inhibitor resistance.
Source:
Title:
eIF4A Inhibitors Suppress Cell-Cycle Feedback Response and Acquired Resistance to CDK4/6 Inhibition in Cancer
Excerpt:
Furthermore, ER+ breast cancer and KRAS-mutant NSCLC cells that acquired resistance to palbociclib after chronic drug exposure are also highly sensitive to this combination treatment strategy.
DOI:
10.1158/1535-7163.MCT-19-0162
