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Efficacy and Safety of Dalpiciclib Plus Toremifene in the Treatment of Advanced First-line HR Positive and HER2 Negative Breast Cancer: a Multicenter, Single Arm, Exploratory Phase II Clinical Study

NCT06495515 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-07-10

No results posted yet for this study

Summary

Experimental population:Advanced first-line HR+, HER2 metastatic breast cancer patients

Research endpoint:

Main research endpoint:

PFS evaluated by researchers (according to RECIST 1.1 standard)

Secondary study endpoint:

ORR、CBR、DCR、OS The incidence of adverse events (AE) and severe adverse events (SAE)

Exploratory study endpoint:

Tumor infiltrating lymphocytes (sTIL) Peripheral blood lymphocyte ratio Distribution of fecal microbiota Research overall design:This study adopts a prospective, single arm design, and plans to include 36 postmenopausal or premenopausal/perimenopausal patients with metastatic breast cancer who are HR positive and HER2 negative, and receive maintenance treatment with darcy plus toremifene. In this study, the screening period did not exceed 28 days. After completing the screening examination and evaluation, eligible subjects entered the study treatment period and received maintenance treatment with darcilib combined with toremifen, for a period of 4 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or termination of medication as determined by the investigator. Conduct research according to the plan regulations Treatment and visits. Perform tumor imaging evaluation every 2 cycles (8 weeks ± 7 days) during the first 13 treatment cycles (52 weeks) of the treatment period; Afterwards, tumor imaging evaluation will be conducted every 3 cycles (12 weeks ± 7 days). Subjects should visit the research center at the end of treatment/withdrawal from the study to complete corresponding safety checks and imaging evaluations; And visit the research center 28 days after the last treatment to complete the corresponding safety assessment.

Conditions

  • CANCER
  • BRAEST CANCER
  • Late Frontline

Interventions

DRUG

Dalpiciclib，Toremifen

1. Dalpiciclib : 150mg orally, once a day, taken for 3 weeks, stopped for 1 week, with a cycle of 4 weeks. It is recommended to take medication at the same time every day, with warm water for delivery. It is recommended to do so on an empty stomach and fast for at least 1 hour before and after taking the medication. 2. Toremifen: 60mg orally, once a day If it is a premenopausal or perimenopausal patient, it is necessary to combine with OFS (OFS includes bilateral ovariectomy or GnRHa drugs).

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-07-30
Completion
2026-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06495515 on ClinicalTrials.gov