Phase II randomized controlled study of the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in Luminal B1 (HR+) breast cancer at high risk of recurrence

Phase II randomized controlled study of the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in Luminal B1 (HR+) breast cancer at high risk of recurrence - Phase II randomized controlled study of the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in Luminal B1 (HR+) breast cancer at high risk of recurrence

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072950

Enrollment

Unknown

Registered

2023-06-28

Start date

2023-07-01

Completion date

Unknown

Last updated

2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Experimental group:Neoadjuvant chemotherapy combined with endocrine therapy

Control group:Neoadjuvant chemotherapy

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Female subjects, aged 18-70 years; 2) meeting criteria for neoadjuvant treatment; 3) Subjects with confirmed primary invasive LuminalB1 breast cancer (LuminalB1 breast cancer defined as ER+, HER2- and meeting any of the following criteria: Ki67 = 20%, PR- or <20%,); 4) At high risk of recurrence: regional lymph node positive, ER/PR positive and HER2 negative when one of the following conditions is met: histology grade III; tumor size = 5 cm; or Ki67 = 20%. 5) Never experienced treatment related to breast cancer, including drugs and surgery, prior to the visit; 6) Subjects were evaluated by a relevant experienced physician prior to treatment ECOG physical status score ranging from 0 to 2; 7) normal blood biochemical parameters and normal liver and kidney function; 8) No history of other systemic tumors; 9) Ability to understand the study protocol and resources to participate in the study and sign the informed consent form 10) good compliance, able to cooperate with the examination and follow-up;

Exclusion criteria

Exclusion criteria: 1) who refuse or are unable to use acceptable methods of contraception during the course of neoadjuvant treatment for breast cancer 2) women who are pregnant and breastfeeding after pregnancy 3) women with distant metastases from breast cancer and confirmed 4) Subjects with sensory or motor neuropathy and confirmed by the relevant department 5) Subjects with severe cardiovascular disease, cardiopulmonary insufficiency, active infection and HIV infection 6) subjects with a history of other malignancies 7) allergic to therapeutic drugs or their excipients, etc; 8) Contraindications to chemotherapy 9) serious mental illness or other diseases that affect patient compliance

Design outcomes

Primary

Measure	Time frame
Pathological remission rate;	—

Secondary

Measure	Time frame
RR;iDFS;OS;DRFS;AEs;	—

Countries

China

Contacts

Public ContactHong-Guang Liu

Shenzhen Second People's Hospital

lhguang2006@126.com+86 186 7475 2925

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026