Not yet recruiting NCT07745257
Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Culmerciclib, Anlotinib, Endocrine Therapy.
- Who it may be relevant to
- Registry conditions: HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases：a Multicenter, Single-arm, Phase Ⅱ Trial
Overview
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.
Interventions
- Drug Culmerciclib
180 mg orally once daily - Drug Anlotinib
12 mg orally once daily on Days 1-14 of every 3-week cycle - Drug Endocrine Therapy
administered per approved prescribing information
Primary outcome measures
- CNS progression-free survival(CNS-PFS) [Time frame: From enrollment to the end of treatment at 8 months]
Secondary outcome measures (5)
- progression-free survival (PFS) [Time frame: From enrollment to the end of treatment at 8 months]
- objective response rate (ORR) [Time frame: From enrollment to the end of treatment at 8 months]
- intracranial objective response rate（IC-ORR) [Time frame: From enrollment to the end of treatment at 8 months]
- Overall Survival (OS) [Time frame: From enrollment to the end of treatment at 18 months]
- Safety and Adverse Events [Time frame: From enrollment to the end of treatment at 9 months]
Eligibility criteria
Inclusion criteria
- Women aged ≥ 18 years
- ECOG PS of 0-1
- Life expectancy of at least 12 weeks
- histologically or cytologically documented HR+/HER2- breast cancer
- radiologically confirmed brain parenchymal metastases without the need for immediate local therapy
- measurable brain metastasis lesion according to RANO-BM criteria
- Must have active brain metastases, defined as newly diagnosed brain metastases or progressive brain metastases following prior local therapy
- Prior systemic therapy must meet all the following criteria：
- No more than 3 lines of prior systemic therapy for advanced disease
- No more than 1 line of chemotherapy or antibody-drug conjugate (ADC) administered in the advanced setting
- No prior CDK4/6 inhibitor therapy for advanced disease, or only 1 line of CDK4/6 inhibitor therapy with treatment duration > 6 months
- Adequate hematological, hepatic and renal function
- Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 180 days after the last dose of experiment treatment
- Patients must be able to participate and comply with treatment and follow-up
Exclusion criteria
- Patients with leptomeningeal metastases, brainstem metastases or skull metastases
- Prior receipt of anti-angiogenic agents or Culmerciclib
- Unresolved Grade ≥2 toxicities (per CTCAE Version 6.0) attributable to any prior therapy, except alopecia
- Patients with visceral crisis,defined as severe organ dysfunction assessed by symptoms, signs, laboratory examinations and rapid disease progression
- Inability to swallow capsules or tablets
- Any severe and/or uncontrolled medical disease
- Other malignancies diagnosed within 5 years, excluding cured non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma
- Radiographic evidence of tumor invasion of major vessels, or high risk of tumor invasion into major vessels resulting in life-threatening hemorrhage as assessed by the investigator
- Patients with arterial or venous thromboembolic events within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism
- Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment
- Any other condition that the investigator considers inappropriate to participate in this trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 9 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- The Fourth Hospital of Hebei Medical University — Shijiazhuang
- Anyang Tumor Hospital — Anyang
- Henan Cancer Hospital — Zhengzhou
- Nanjing Drum Tower Hospital — Nanjing
- Nanchang People's Hospital — Nanchang
- The Second Affiliated Hospital of Dalian Medical University — Dalian
- Sichuan Provincial People's Hospital — Chengdu
- … and 1 more center
Identifiers
NCT: NCT07745257 · SL-B2026-363-01