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Trial Title:
Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy
NCT ID:
NCT05806671
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fulvestrant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
Dalpiciclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off
Arm group label:
Dalpiciclib, Fulvestrant With Pyrotinib
Other name:
SHR6390
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
Pyrotinib 320mg/day orally continuously
Arm group label:
Dalpiciclib, Fulvestrant With Pyrotinib
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
Fulvestrant 500mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each
subsequent 28 day cycle
Arm group label:
Dalpiciclib, Fulvestrant With Pyrotinib
Summary:
The purpose of this study is to determine if the triplet combination of dalpiciclib,
fulvestrant, and pyrotinib is safe and effective in the treatment of hormone
receptor-positive, HER2-low locally advanced/metastatic breast cancer following treatment
with an aromatase inhibitor plus a CDK4/6 inhibitor (palbociclib abemaciclib or
ribociclib).
The study will employ a Bayesian Optimal Phase II (BOP2) design which explicitly controls
the type I error rate, thereby bridging the gap between Bayesian designs and frequentist
designs, and has favorable operating characteristics with higher power and lower risk of
incorrectly terminating the trial than some existing Bayesian phase II designs.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men or women at least 18 years of age with histologically or cytologically confirmed
adenocarcinoma of the breast with unresectable or metastatic disease.
2. Most recent tumor biopsy or surgical resection specimen must be either
estrogen-receptor (ER) positive, progesterone receptors (PgR) positive, or both, as
defined by immunohistochemistry (IHC) ≥1% (as per the American Society of Clinical
Oncology (ASCO)-College of American Pathologists (CAP) guidelines).
3. HER2-low breast cancer defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested). (as per
the ASCO-CAP guidelines).
4. Postmenopausal status or receiving ovarian ablation with a GnRH agonist such as
goserelin. Postmenopausal status is defined by any one of the following criteria:
- Prior bilateral oophorectomy.
- Age ≥60 years.
- Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy,
tamoxifen, toremifen, or ovarian suppression) and FSH, LH, and estradiol in the
postmenopausal range per local normal If the patient does not meet criteria for
postmenopausal status but is receiving ovarian ablation therapy with a
gonadotropin-releasing hormone (GnRH) agonist such as goserelin, the patient is
eligible for this study, provided that the GnRH agonist is started at least 2
weeks prior to C1D1 of anti-estrogen therapy.
5. Patient must have either measurable disease by RECIST 1.1 or only bone lesions in
absence of measurable disease.
6. Eastern Cooperative Group (ECOG) performance status of 0 or 1.
7. Previously treated on CDK 4/6 inhibitor(palbociclib, abemaciclib or ribociclib) with
AI for at least 6 months
8. Adequate bone marrow and organ function.
Exclusion Criteria:
1. Patient with symptomatic visceral disease or any disease burden.
2. Patient has received more than one line of chemotherapy for advanced disease.
3. Previous treatment with Dalpiciclib /Pyrotinib /ADCe for advanced disease.
4. Progressed on more than one CDK 4/6 inhibitor
5. Patients with persistent symptoms and unstable brain metastases;
6. Any condition that makes the patient ineligible for endocrine therapy per the
investigator's best judgment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Country:
China
Start date:
May 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806671
