^
Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Ibrance (palbociclib) (CDK4/6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Detection of circulating tumor DNA following neoadjuvant chemotherapy and surgery to anticipate early relapse in ER positive and HER2 negative breast cancer: Analysis from the PENELOPE-B trial.
Published date:
05/25/2023
Excerpt:
The PENELOPE-B phase III trial investigated the addition of one year of palbociclib to endocrine therapy (ET), in patients with hormone receptor positive HER2 negative breast cancer with residual invasive disease after neoadjuvant chemotherapy....Seven patients had baseline ctDNA detected, with detection strongly associated with iDFS (HR 8.8, 95% CI 3.3-23.4, p < 0.0001). Detection of ctDNA at cycle 7 (4 patients) was also strongly associated with iDFS (HR 25.5, 95% CI 6.5-99.6, p < 0.0001).
Secondary therapy:
Hormone Therapy
DOI:
10.1200/JCO.2023.41.16_suppl.502
Trial ID:
Source:
Title:
228MO - PALOMA-4: Primary results from a phase III trial of palbociclib (PAL) + letrozole (LET) vs placebo (PBO) + LET in Asian postmenopausal women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative (ER+/HER2–) advanced breast cancer (ABC)
Published date:
09/13/2021
Excerpt:
PALOMA-4, an international, double-blind, phase 3 trial, randomized postmenopausal Asian women who had not received prior systemic therapy for ER+/HER2– ABC 1:1 to receive PAL (125 mg/d orally; 3 weeks on, 1 week off) + LET (2.5 mg/d orally; continuously) or PBO + LET. The median duration of follow-up for overall survival was 52.8 mo. At the data cutoff (Aug 31, 2020), the median PFS based on investigator assessment was 21.5 mo for PAL + LET and 13.9 mo for PBO + LET (hazard ratio, 0.68 [95% CI, 0.53–0.87]; P=0.0012). The ORR based on investigator assessment was 37.3% vs 31.6%, respectively, among all pts (P=0.154) and 43.4% vs 38.0% in pts with measurable disease (P=0.206). PALOMA-4, the largest study to date of a cyclin-dependent kinase 4/6 inhibitor in Asian pts with ABC, confirmed the efficacy and safety of PAL + LET as first-line therapy in postmenopausal Asian women with ER+/HER2– ABC.
Secondary therapy:
letrozole
Trial ID:
Source:
Title:
Efficacy and safety of palbociclib in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2
Published date:
07/27/2021
Excerpt:
This post hoc analysis of PALOMA-2 evaluated the efficacy and safety of palbociclib plus letrozole...in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ABC)....Regardless of baseline preexisting condition, palbociclib plus letrozole prolonged PFS compared with placebo plus letrozole....This post hoc analysis of PALOMA-2 demonstrated a favorable effect of palbociclib on PFS...
Secondary therapy:
letrozole
DOI:
10.1016/j.breast.2021.07.017
Trial ID:
Source:
Title:
Efficacy of AI and palbociclib in ER+ HER2- advanced breast cancer patients relapsing during adjuvant tamoxifen: An exploratory analysis of the PADA-1 trial.
Published date:
05/19/2021
Excerpt:
...ER+ HER2- advanced breast patients (ABC pts) received Aromatase Inhibitor (AI) and Palbociclib (Pal)...The median PFS under AI+PAL was 20.4 months (95%CI16.1;27.8) in patients relapsing during adjuvant TAM. In contrast, median PFS in patients with de novo metastatic disease and metastatic relapses after the completion of adjuvant endocrine therapy were 30.6 months (95%CI26.7;Not reached) and 27.8 months (95%CI24.1;30.)], respectively.
Secondary therapy:
Aromatase inhibitor
DOI:
10.1200/JCO.2021.39.15_suppl.1070
Trial ID:
Source:
Title:
Efficacy and safety of palbociclib (PAL) in patients (pts) with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with preexisting conditions: A post hoc analysis of PALOMA-2
Published date:
11/17/2020
Excerpt:
PAL + LET showed prolonged PFS and a consistent safety profile regardless of baseline preexisting condition in pts with ER+/HER2– ABC.
Secondary therapy:
letrozole
Trial ID:
Source:
Title:
Palbociclib Plus Letrozole as First-Line Therapy in Postmenopausal Asian Women With Metastatic Breast Cancer: Results From the Phase III, Randomized PALOMA-2 Study
Published date:
05/24/2019
Excerpt:
Of 666 enrolled postmenopausal women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer...Consistent with the overall study population, the addition of palbociclib to letrozole significantly improved PFS in Asians.
Secondary therapy:
letrozole
DOI:
10.1200/JGO.18.00173
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:
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:
...- ER-positive and/or PR-positive tumor based on local laboratory results...
Trial ID:
More C2 evidence
Source:
Title:
Phase Ia/b Study of Giredestrant ±Palbociclib and ±Luteinizing Hormone-releasing Hormone Agonists in Estrogen Receptor-positive, HER2-negative, Locally Advanced/Metastatic Breast Cancer
Published date:
11/03/2023
Excerpt:
Clinical benefit was observed in all cohorts (48.6% of patients in the single-agent cohort and 81.3% in the giredestrant +palbociclib ±LHRH agonist cohort)...Giredestrant was well tolerated and clinically active in patients who progressed on prior ET.
Secondary therapy:
GDC-9545
DOI:
10.1158/1078-0432.CCR-23-1796
Trial ID:
Source:
Title:
Overall survival in Japanese patients with ER+/HER2- advanced breast cancer treated with first-line palbociclib plus letrozole
Published date:
10/26/2023
Excerpt:
In this population of Japanese women with ER+/HER2- ABC, median OS was over 7 years with 1L PAL + LET, supporting the use of 1L PAL + endocrine therapy.
Secondary therapy:
letrozole
DOI:
10.1007/s12282-023-01511-z
Trial ID:
Source:
Title:
Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study
Published date:
09/01/2023
Excerpt:
112 patients were evaluable for objective response rate in the giredestrant plus palbociclib group, and 108 were evaluable in the anastrozole plus palbociclib group. Objective response rates were similar between the two groups (56 [50·0%] of 112 [95% CI 40·4–59·6] with giredestrant plus palbociclib vs 53 [49·1%] of 108 [39·3–58·9] with anastrozole plus palbociclib...Giredestrant offers encouraging anti-proliferative and anti-tumour activity and was well tolerated, both as a single agent and in combination with palbociclib.
Secondary therapy:
GDC-9545
DOI:
https://doi.org/10.1016/S1470-2045(23)00268-1
Trial ID:
Source:
Title:
Neoadjuvant giredestrant + palbociclib (P) vs. anastrozole (A) + P in postmenopausal women with estrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+, HER2– eBC): Patient (pt)-reported outcomes (PROs) in the randomized, open-label, international phase II coopERA BC study.
Published date:
05/25/2023
Excerpt:
Pts with cT1c-cT4a-c (≥ 1.5 cm within cT1c) ER+, HER2– untreated eBC and baseline Ki67 score ≥ 5% were randomized 1:1 to 30 mg PO daily (QD) giredestrant or 1 mg PO...FACT-G GP5 showed greater proportions of “improved/no change” responses in the giredestrant + P than the A + P arm at Cycles 2–4 (Cycle 2 75%; Cycle 3 71%; Cycle 4 68% vs. 62%; 66%; 53%)....Furthermore, there were numeric trends towards greater stability and improvement and less worsening of treatment burden in the giredestrant + P arm.
Secondary therapy:
GDC-9545
DOI:
10.1200/JCO.2023.41.16_suppl.591
Trial ID:
Source:
Title:
A retrospective, non-interventional study of breast cancer patients diagnosed with ER+/HER2 negative, locally advanced or metastatic breast cancer treated with palbociclib in Denmark
Published date:
04/03/2023
Excerpt:
This retrospective, population-based study included all Danish, advanced breast cancer patients with ER+/HER2 negative disease who initiated first- or second-line treatment with palbociclib...Median OS was 51.7 months (95% CI, 44.9-54.6) for all patients in the first-line setting (n = 728) and median PFS was 24.3 months (95% CI, 21.7-27.8).
DOI:
10.1080/0284186X.2023.2194030
Source:
Title:
Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer: Primary results from PALOMA-4
Published date:
09/22/2022
Excerpt:
Median (95% CI) PFS was 21.5 (16.6–24.9) months with palbociclib plus letrozole and 13.9 (13.7–16.6) months with placebo plus letrozole (hazard ratio, 0.68 [95% CI, 0.53–0.87]; P = 0.0012)….Findings from PALOMA-4 support the efficacy and safety of first-line palbociclib plus letrozole in postmenopausal Asian women with ER+/HER2– ABC.
Secondary therapy:
letrozole
DOI:
10.1016/j.ejca.2022.08.012
Trial ID:
Source:
Title:
Neoadjuvant giredestrant (GDC-9545) plus palbociclib (P) versus anastrozole (A) plus P in postmenopausal women with estrogen receptor–positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): Final analysis of the randomized, open-label, international phase 2 coopERA BC study
Published date:
05/26/2022
Excerpt:
Consistent with the primary analysis, greater suppression of Ki67 was observed at surgery with giredestrant + P (–81% [95% confidence interval (CI): –86%, –75%]) vs A + P (–74% [95% CI: –80%, –67%]). Similarly, greater CCCA was achieved at surgery with giredestrant + P (20%) vs A + P (14%). ORR was similar between the two arms (giredestrant + P: 50% [95% CI: 40%, 60%]; A + P: 49% [95% CI: 39%, 59%]). coopERA BC is the first randomized study to show superior antiproliferative activity of an oral SERD (giredestrant) over an aromatase inhibitor (A) in ER+/HER2– eBC...
Secondary therapy:
GDC-9545
DOI:
10.1200/JCO.2022.40.16_suppl.589
Trial ID:
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:
Pathological complete response rates were 3.8% and 5.9%....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:
10.1016/j.ejca.2022.01.014
Source:
Title:
Palbociclib in combination with aromatase inhibitors in patients ≥ 75 years with oestrogen receptor-positive, human epidermal growth factor receptor 2 negative advanced breast cancer: A real-world multicentre UK study
Published date:
10/28/2021
Excerpt:
The clinical benefit rate was 87%. 50.7% of patients had dose reductions and 59.3% had dose delays. The 12- and 24- month PFS rates were 75.9% and 64.9%, respectively. The 12- and 24- month OS rates were 85.1% and 74.0%, respectively….Palbociclib is an effective therapy in the real-world older population and is well-tolerated with low levels of clinically significant toxicities.
DOI:
10.1016/j.breast.2021.10.010
Source:
Title:
LBA14 - Neoadjuvant giredestrant (GDC-9545) + palbociclib (palbo) vs anastrozole (A) + palbo in post-menopausal women with oestrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): Interim analysis of the randomised, open-label, phase II coopERA BC study
Published date:
09/13/2021
Excerpt:
coopERA BC (NCT04436744) investigates giredestrant vs A (both + palbo) in post-menopausal women with ER+/HER2– eBC....At Week 2, 25% of tumours exhibited CCCA with giredestrant vs 5% with A (Δ 20%; 95% CI = –37%, –3%)....Interim analysis data demonstrated superior anti-proliferative activity of giredestrant compared with A.
Secondary therapy:
GDC-9545
Trial ID:
Source:
Title:
245P - Palbociclib combined with aromatase inhibitors (AIs) in women ≥75 years with oestrogen receptor positive (ER+ve), human epidermal growth factor receptor 2 negative (HER2-ve) advanced breast cancer: A real-world multicentre UK study
Published date:
09/13/2021
Excerpt:
Patients aged ≥75 years who received at least one cycle of palbociclib combined with an AI for first-line treatment of advanced ER+ve/HER2-ve breast cancer were eligible….The PFS rates at 12 and 24 months were 75.9% and 64.9%, respectively. The best radiological response was complete response (2%), partial response (32.9%) and stable disease (54.9%) with a clinical benefit rate at 24 weeks of 87%.
Secondary therapy:
Aromatase inhibitor
Source:
Title:
Rintodestrant (G1T48), an oral selective estrogen receptor degrader, in combination with palbociclib for ER+/HER2– advanced breast cancer: Phase 1 results.
Published date:
05/19/2021
Excerpt:
Rintodestrant, as monotherapy or combined with palbociclib, continues to demonstrate an excellent safety/tolerability profile with promising antitumor activity in pts with ER+/HER2– ABC, including those with ESR1 variants.
Secondary therapy:
G1T48
DOI:
10.1200/JCO.2021.39.15_suppl.1063
Trial ID:
Source:
Title:
AMEERA-1: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with palbociclib (palbo) in postmenopausal women with ER+/ human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).
Published date:
05/19/2021
Excerpt:
Patients (pts) were postmenopausal women with ER+/HER2– Mbc...In pts with ER+/HER2– mBC, safety at the RP2D of amcenestrant + palbo was favorable...Preliminary antitumor activity after at least 6 cycles of therapy (unless early treatment discontinuation) is reported in the table below....Preliminary antitumor activity was observed (ORR: 31.4% and CBR: 74.3%)….
Secondary therapy:
SAR439859
DOI:
10.1200/JCO.2021.39.15_suppl.1058
Trial ID:
Source:
Title:
63O - Letrozole and palbociclib versus 3rd generation chemotherapy as neoadjuvant treatment in luminal breast cancer: survival results of the UNICANCER-NeoPAL study
Published date:
05/03/2021
Excerpt:
Postmenopausal women with ER-positive, HER2-negative...were randomly assigned to either letrozole (2.5 mg daily) and palbociclib (125 mg daily, 3 weeks/4) during 19 weeks (LETPAL)...40 months PFS rate is 86.7% (78.0-96.4) and 87.2% (78.1-97.4) in LETPAL and CT arms respectively....LETPAL strategy, together with selected postoperative administration of chemotherapy, may spare chemotherapy in some pts with LBC...
Trial ID:
Source:
Title:
Palbociclib-letrozole as first-line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study
Published date:
05/18/2020
Excerpt:
Palbociclib plus letrozole remained effective and tolerable in Japanese postmenopausal patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in this updated analysis.
Secondary therapy:
letrozole
DOI:
10.1002/cam4.3091
Trial ID:
Source:
Title:
A phase Ib study to evaluate the oral selective estrogen receptor degrader GDC-9545 alone or combined with palbociclib in metastatic ER-positive HER2-negative breast cancer.
Published date:
05/13/2020
Excerpt:
GDC-9545 was well-tolerated as a single agent and in combination with palbociclib with encouraging PK, PD, and anti-tumor activity in ER+ MBC to support Phase III development.
Secondary therapy:
GDC-9545
DOI:
10.1200/JCO.2020.38.15_suppl.1023
Trial ID:
Source:
Title:
Successful Treatment of Estrogen Receptor Positive, HER2 Negative Breast Cancer with Life-Threatening Multiple Bone Metastases Using the Combination of Fulvestrant and Palbociclib-A Case Report
Published date:
10/02/2021
Excerpt:
Palbociclib, a CDK4/6 inhibitor, is found to be an effective therapeutic drug in the treatment of estrogen receptor positive (ER+)metastatic breast cancer. In this report, we describe a case of rapid progression of life-threatening multiple bone metastases of breast cancer treated with a combination of fulvestrant and palbociclib....The patient responded well to the treatment, and her general condition improved to PS 1.
Secondary therapy:
fulvestrant
Source:
Title:
Abstract 1501: Exceptional response to anti HER-2 targeted therapy in patient with HER2/neu negative breast cancer with HER2/neu positive CTCs
Published date:
05/15/2020
Excerpt:
R axillary node biopsy revealed breast cancer cells ER+, PR-, HER2-....started palbociclib plus letrozole which continued for 15 months with no evidence of disease on serial repeat imaging.
Secondary therapy:
letrozole
DOI:
10.1158/1538-7445.AM2020-1501
