Combination treatment for women with advanced breast cancer after previous therapy failure
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.
This study is testing a new combination treatment for women with advanced breast cancer who haven't had success with previous therapies to see if it can help them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06133088 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical study investigates the safety and efficacy of a combination therapy involving dalpiciclib, fulvestrant, and compound gossypol acetate tablets in women with advanced HR-positive and HER2-negative metastatic breast cancer who have previously failed CDK4/6 inhibitor treatment. Participants will receive dalpiciclib orally for three weeks followed by a one-week break, fulvestrant administered every four weeks, and daily doses of compound gossypol acetate. The study aims to evaluate the potential benefits of this combination therapy in a single-arm design.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with HR-positive HER2-negative metastatic breast cancer who have failed previous CDK4/6 inhibitor treatments.
Not a fit: Patients currently enrolled in other interventional clinical trials or those with a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for women with advanced breast cancer who have exhausted other treatment avenues.
How similar studies have performed: While this approach is novel, previous studies have shown promise in combining targeted therapies for similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- zhejiangCH — Hangzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.