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

NCT05431504 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-BC-II-033
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, single-arm, open-label, Simon's two-stage exploratory clinical trial. 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I. If the study enter stage 2 and continue to include 53 assessable subjects (35 in stage 2). All eligible patients will receive Dalpiciclib plus endocrine therapy chosen by the Physicians until disease progression, death or intolerable toxicity. Tumor assessment was conducted according to RECIST 1.1 criteria.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 6-month-OS rate

  6-month-Overall Survival rate. Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death.

  From the start of treatment to 6 month

Secondary Outcomes (9)

• Overall Survival (OS)

  From the start of treatment to 36 month

• 1-year-OS rate

  From the start of treatment to 12 month

• Progression-Free Survival (PFS)

  From the start of treatment to 36 month

• Time to treatment failure (TTF)

  From the start of treatment to 36 month

• Objective Overall Response Rate (ORR)

  From the start of treatment to 36 month

Study Arms (1)

Treatment group

EXPERIMENTAL

Dalpiciclib in combination with endocrine therapy by physicians choice

Drug: Dalpiciclib in combination with endocrine therapy by Physicians choice

Interventions

Dalpiciclib in combination with endocrine therapy by Physicians choice DRUG

Dalpiciclib 150 mg orally once daily for 3 weeks, followed by 1 week off in each 4-week cycle. Endocrine therapy including but not limited to fulvestran, tanastrozole, letrozole or exemestane In regular doses

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal or premenopausal/perimenopausal women aged ≥18 meet one of the following:
• A) Previous bilateral oophorectomy, or age ≥60 years; or B) age\<60. Natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; or C) premenopausal/perimenopausal women must receive LHRH agonists therapy during the study.
• Female breast cancer patients diagnosed as HR-positive or HER2-negative by pathological examination are not suitable for surgical resection or radiotherapy for the purpose of cure.
• A) ER-positive and/or PR-positive are defined as: ≥ 1% of all tumor cells are positively stained (confirmed by investigator review at the site); B) HER2-negative are defined as: 0/1 + by standard immunohistochemistry (IHC); HER2/CEP17 ratio less than 2.0 by ISH or HER2 gene copy number less than 4 (confirmed by investigator review at the site).
• Any clinical signs or symptoms of symptomatic brain metastasis or visceral metastasis (at least one of the following: carcinomatous meningitis or leptomeningeal metastasis; pleural effusion; ascites; abdominal pain caused by liver or peritoneal metastasis; dyspnea caused by pleural effusion or pulmonary lymphangitis; elevated liver enzymes (\> 2 × ULN); rapid elevation of bilirubin \> 1.5 × ULN in the absence of Gilbert's syndrome or biliary obstruction; pathologically confirmed bone marrow metastasis; hemoglobin less than 10 g) and patients who cannot tolerate chemotherapy or are considered by the investigator to be inappropriate for chemotherapy or chemotherapy.
• Adequate bone marrow function. Definitions are as follows: a) neutrophil count (ANC) ≥ 1,500/mm3 (1.5 x 109L) (14 without growth factors); b) platelet count (PLT) ≥ 100,000/mm3 (100 x 109L) (7 without correction); c) hemoglobin (Hb) ≥ 8 g/dL (80 g/L) (7 without correction).
• Female subjects who are not postmenopausal or surgically sterile must have a serum pregnancy test within 7 days before the first dose and have a negative result, and are willing to abstain from sexual intercourse or use a medically recognized highly effective contraceptive measure after signing the informed consent, during the study, and for 1 year after administration of the study drug.
• Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

You may not qualify if:

• Patients contraindicated with dalpiciclib.
• Patients with primary resistance to endocrine therapy. Relapse within 2 years of adjuvant endocrine therapy, or disease progression within 6 months of advanced first-line endocrine therapy.
• Patients with more than 3 lines of prior endocrine therapy.
• Patients previously treated with any CDK4/6 inhibitor.
• Patients with simple bone metastasis.
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method) or combined hepatitis B and C co-infection.
• Within 6 months before enrollment, the following conditions occur: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, ≥ grade 2 persistent arrhythmia (according to NCI CTCAE v5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack) or symptomatic pulmonary embolism.
• Severe infection occurring within 4 weeks (such as intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical practice) before the first dose, or unexplained fever \> 38.5℃ during screening/before the first dose.
• Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption.
• Known hypersensitivity to dalpiciclib and any of its excipients.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Known history of psychiatric drug abuse or drug use;
• Female patients who are pregnant or lactating.
• Any other condition that the investigator considers the subject unsuitable for this study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

dalpiciclib

Study Officials

• Fei Ma

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ma

CONTACT

86-10-87788060; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)