Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.

NCT ID: NCT06133088

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-08-31

Brief Summary

This is a single-arm, Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK4/6 treatment failed.

Detailed Description

Dalpiciclib: According to the standard dose, 150mg orally for three weeks and stop for one week.

Fluvestrant: At the standard dose, 500mg once every four weeks. A further 500mg dose two weeks after the first dose.

Compound gossypol acetate tablets: 20mg once a day.

Conditions

Advanced HR-positive and HER2-negative Breast Cancer; CDK4/6 Inhibitor Treatment Failed

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

This is a single-arm, Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK4/6 treatment failed.

Group Type: EXPERIMENTAL

dalpiciclib; fluvestrant; compound gossypol acetate tablets

Intervention Type: DRUG

Darcilie: 150mg orally for three weeks and stop for one week. Fluvestrant: 500mg every four weeks. A further 500mg dose two weeks after the first dose.

Compound gossyrol acetate tablet: 20mg daily.

Interventions

dalpiciclib; fluvestrant; compound gossypol acetate tablets

Darcilie: 150mg orally for three weeks and stop for one week. Fluvestrant: 500mg every four weeks. A further 500mg dose two weeks after the first dose.

Compound gossyrol acetate tablet: 20mg daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1.Written informed consent. 2.Women aged 18 years or older. 3.Eastern Cooperative Oncology Group(ECOG) has a physical fitness score of 0 or 1. 4.Life expectancy is more than six months. 5.Diagnosed as HR-positive HER2-negative metastatic breast cancer. 6.There was at least one measurable lesion according to RECIST 1.1. 7.Failed in treating with CDK4/6 inhibitors combined with endocrine therapy at the metastatic stage. 8.Good organ function. 9.Fertile female patients must have a negative serum pregnancy test within seven days prior to study treatment and consent to effective contraceptive use for 180 days from screening to the last dose of study treatment. 10.Female patients must agree not to breastfeed during the study period or for 180 days after the last dose of study therapy.

Exclusion Criteria

1.Patients enrolled in any interventional clinical trial at the same time and received the investigational therapy ≤ four weeks prior to initiation of the regimen or at least five half-lives of the investigational drug. 2.Patients who had received radiation therapy with bone marrow coverage >20% within two weeks before the start of treatment, except for minor palliative radiation therapy more than one week before the first day of the study. 3.Patients with a visceral crisis, and requiring chemotherapy. 4.Patients allergic to dalpiciclib or compound gossyrol acetate tablets. 5.A history of platelet transfusion for chemotherapy-induced thrombocytopenia or prior cancer treatment (lasting > 4 weeks and associated with recent treatment) is known to result in ≥ grade 3 hematological toxicity. 6.The patient had any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 7.Patients have a severe, uncontrolled medical condition, a non-malignant systemic disease, or an active, uncontrolled infection. 8.Patients diagnosed, detected, or treated for another type of cancer within ≤2 years prior to beginning regimen therapy.

Patients with brain metastases or pial metastases uncontrolled. 9.Patients have received an allogeneic bone marrow transplant or double umbilical cord blood transplant. 10.Patients cannot swallow oral medications. 11.Patients with gastrointestinal disorders that may interfere with the absorption of investigational drugs. 12.Patients have had systemic active autoimmune disease (i.e., disease modulators, corticosteroids, or immunosuppressants) within the past two years. 13.Patients with a history of human immunodeficiency virus, active-hepatitis -B or C. 14.Pregnant or nursing women. Fertile adults without effective contraceptive methods.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shao Xiying

Medical team leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

zhejiangCH

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ying Xi Shao, doctor

Role: primary

15824113524@163.com

15824113524

Other Identifiers

HIM-B002a

Identifier Type: -

Identifier Source: org_study_id