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

Conditions

Luminal B/HER2-negative Breast Cancer

Brief summary

Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.

Zhou Y, Zhang Z, Chen H, Huang F, Shen L, Tao S, Qian W, Hong H, Pan C, Wang Z, Zhang J, Hu Y, Shen Y, Fu J, Mao W, Wu S, Guo X, Wang H, Ma M, Ma T, Pan L, Chen Y.

2025-10-11

10.1002/mco2.70402

Biomarkers of neoadjuvant dalpiciclib in patients with operable HER2-negative luminal B breast cancer in the DANCER trial.

Yunxiang Zhou, Zhiyun Zhang, Yiding Chen

Journal of Clinical Oncology2025-05-28

10.1200/jco.2025.43.16_suppl.600

Neoadjuvant dalpiciclib combined with aromatase inhibitors in stage I-III HER2 negative luminal B breast cancer (DANCER): Preliminary findings from an ongoing phase II study.

Yunxiang Zhou, Zhiyun Zhang, Huihui Chen, Yuyang Miao, Yiding Chen

Journal of Clinical Oncology2024-06-011 citations

10.1200/jco.2024.42.16_suppl.e12622

Interventions

DRUGDalpiciclib combined with aromatase inhibitors

Dalpiciclib combined with letrozole or anastrozole

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Patient is ≥ 18 years-old at the time of consent to participate this trial * Famale stage I-III breast cancer patients * HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR\<20% * No prior anti-cancer treatment * ECOG 0-1

Exclusion criteria

* Known to have other aggressive malignant tumor in the past 5 years. * Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology. * There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. * Female patients during pregnancy or lactation. * The investigator determines that subjects are not appropriate to participate in the study due to other factors.

Design outcomes

Primary

Measure	Time frame	Description
Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment	3 years	Assess ki67 level through biopsy samples of patients

Secondary

Measure	Time frame	Description
Objective response rate (ORR)	3 years	the proportion of people with clinical complete response(CR) or partial response(PR), per RECIST v1.1

Countries

China

Contacts

Primary ContactYunxiang Zhou

yxzhou@zju.edu.cn+8615868131018

Outcome results

None listed