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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Published date:
05/11/2023
Excerpt:
Median progression-free survival was significantly longer in the dalpiciclib group than in the placebo group (30·6 months [95% CI 30·6-not reached] vs 18·2 months [16·5-22·5]; stratified hazard ratio 0·51 [95% CI 0·38-0·69]; one-sided log-rank p<0·0001)....Our findings suggest that dalpiciclib plus letrozole or anastrozole could be a novel standard first-line treatment for patients with hormone receptor-positive, HER2-negative advanced breast cancer, and is an alternative option to the current treatment landscape.
Secondary therapy:
anastrozole; letrozole
DOI:
10.1016/S1470-2045(23)00172-9
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

229P - Dalpiciclib plus fulvestrant in HR+/HER2− advanced breast cancer (ABC): Updated analysis from the phase III DAWNA-1 trial

Published date:
09/05/2022
Excerpt:
The PFS benefit with dalpiciclib was consistent in postmenopausal women (HR 0.44 [95% CI 0.31-0.62]) and pre- or perimenopausal women (HR 0.55 [95% CI 0.37-0.82]). 86 (35.7%) patients in the dalpiciclib group and 28 (23.3%) in the placebo group achieved an objective response per investigator; the median duration of response was 20.8 mo...The addition of dalpiciclib to fulvestrant continued to demonstrate PFS benefits with no new safety signals identified after prolonged follow-up, further supporting this regimen as a new option for pretreated HR+/HER2− ABC.
Secondary therapy:
fulvestrant
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

LBA16 - Dalpiciclib plus letrozole or anastrozole as first-line treatment for HR+/HER2- advanced breast cancer (DAWNA-2): A phase III trial

Published date:
09/05/2022
Excerpt:
With a median follow-up of 21.7 and 21.4 mo respectively, PFS per INV was significantly improved in the dalp group vs the placebo group (median, 30.6 mo [95% CI 30.6-NR] vs 18.2 mo [16.5-22.5]; HR 0.51 [95% CI 0.38-0.69], 1-sided P <0.0001)....Adding dalp to letrozole/anastrozole significantly prolonged PFS in HR+/HER2- ABC, with manageable toxicities. Dalp is the 4th CDK4/6 inhibitor showing survival benefit with letrozole or anastrozole in untreated HR+/HER2- ABC, or with fulvestrant in pretreated HR+/HER2- ABC...
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial

Published date:
11/04/2021
Excerpt:
The study met the primary end point, showing significantly prolonged investigator-assessed progression-free survival with dalpiciclib plus fulvestrant versus placebo plus fulvestrant (median = 15.7, 95% confidence interval (CI) = 11.1–not reached versus 7.2, 95% CI = 5.6–9.2 months; hazard ratio = 0.42, 95% CI = 0.31–0.58; one-sided P < 0.0001 (boundary was P ≤ 0.008))....This phase 3 trial showed that adding dalpiciclib to fulvestrant significantly prolonged progression-free survival, with a manageable safety profile. Our findings support dalpiciclib plus fulvestrant as a new treatment option for pretreated hormone receptor-positive, HER2-negative ABC.
Secondary therapy:
fulvestrant
DOI:
https://doi.org/10.1038/s41591-021-01562-9
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Dalpiciclib Extends Progression-Free Survival in HR+/HER2– Advanced Breast Cancer

Published date:
06/21/2021
Excerpt:
The phase III DAWNA-1 trial met its primary endpoint of improved progression-free survival with dalpiciclib added to fulvestrant in previously treated HR-positive, HER2-negative advanced breast cancer...
Secondary therapy:
fulvestrant
DOI:
https://doi.org/10.1002/onco.13865
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Dalpiciclib versus placebo plus fulvestrant in HR+/HER2- advanced breast cancer that relapsed or progressed on previous endocrine therapy (DAWNA-1): A multicenter, randomized, phase 3 study.

Published date:
05/19/2021
Excerpt:
...double-blind, phase 3 trial, patients (pts) with HR+/HER2− locally advanced or metastatic breast cancer who had relapsed or progressed on previous endocrine therapy were enrolled….With a median follow-up of 10.5 mo, dalp-fulv significantly improved INV-assessed PFS versus PBO-fulv (median, 15.7 [95% CI 11.1-NR] vs 7.2 [95% CI 5.6-9.2] mo...The study met its primary endpoint, demonstrating that dalpiciclib plus fulvestrant significantly improved PFS versus placebo plus fulvestrant, with a manageable safety profile. Our findings support dalpiciclib plus fulvestrant as a new treatment...
Secondary therapy:
fulvestrant
DOI:
10.1200/JCO.2021.39.15_suppl.1002
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Excerpt:
...Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy

Excerpt:
...Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Dalpiciclib Plus Letrozole and Capecitabine

Excerpt:
...HR-positive, HER2-negative breast cancer diagnosed by pathology, patients have evidence of focal recurrence or metastasis, are...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

Excerpt:
...Female breast cancer patients diagnosed as HR-positive or HER2-negative by pathological examination are...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Excerpt:
...Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)

Excerpt:
...- The recent pathology results showed HR-positive and HER2-negative....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)

Excerpt:
...- HR-positive, HER2-negtive invasive breast cancer, Ki67≥20% or PgR<20%...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Excerpt:
...Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Neoadjuvant stereotactic body radiotherapy plus dalpiciclib and exemestane for hormone receptor-positive, HER2-negative breast cancer.

Published date:
05/25/2023
Excerpt:
The results met the primary endpoint as the therapy resulted in RCB 0-I of 16.7% (2/12, 95% CI 3.5%-46.0%) with the ORR of 91.7% (11/12, 95% CI 62.5%-100%). 2 (16.7%, 95% CI 3.5%-46.0%) patients achieved pCR in the breast and axilla (ypT0/is ypN0). 3 (25.0%, 95% CI 8.3%-53.9%) patients reached pCR in the breast (ypT0/is)…Neoadjuvant SBRT followed by dalpiciclib and exemestane seems effective and tolerable, which may offer an alternative for patients with HR+/HER2- breast cancer.
Secondary therapy:
exemestane
DOI:
10.1200/JCO.2023.41.16_suppl.e12604
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Dalpiciclib in combination with letrozole/anastrozole or fulvestrant in HR+/HER2- advanced breast cancer: A phase Ib study

Published date:
05/26/2022
Excerpt:
Dalp 150 mg was associated with a numerically higher objective response rate in both ET-untreated (67.6%, 95% CI 49.5-82.6) and ET-pretreated (53.3%, 95% CI 26.6-78.7) patients per investigator. The median progression-free survival with Dalp 150 mg was 20.3 mo (95% CI 16.9-not reached [NR]) and 16.7 mo (95% CI 1.9-24.1) in ET-untreated and ET-pretreated patients respectively.
Secondary therapy:
letrozole + anastrozole; fulvestrant
DOI:
10.1200/JCO.2022.40.16_suppl.1066
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A phase 1 study of dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor in Chinese patients with advanced breast cancer

Published date:
04/12/2021
Excerpt:
Between Apr 15, 2016 and Dec 21, 2018, 40 patients were enrolled; all were diagnosed of hormone receptor-positive and HER2-negative ABC. Dalpiciclib 100 mg, 125 mg, and 150 mg cohorts were expanded to 10 patients…Among the three expansion cohorts, the 150 mg cohort had the numerically highest DCR of 80.0% (95% CI: 44.4-97.5) and longest median progression-free survival of 8.4 months (95% CI: 2.1-not reached).
DOI:
10.1186/s40364-021-00271-2
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A phase I study of SHR6390, a cyclin-dependent kinase 4/6 inhibitor in patients with advanced breast cancer (ABC).

Published date:
05/13/2020
Excerpt:
All pts were diagnosed of hormone receptor positive and HER2-negative ABC...The disease control rate was 62.5% (25/40, 95% CI 45.8% to 77.3%). Two pts (5%, one in 125 mg, one in 150 mg cohort) achieved partial response, with responses lasting 169 and 356+ days, respectively.
DOI:
10.1200/JCO.2020.38.15_suppl.1095
Trial ID: