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Metastatic Breast Carcinoma / Biopsy Procedure / Abemaciclib · Phase 1 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration (NCT03939897) testing copanlisib added to fulvestrant and abemaciclib in metastatic HER2-negative, hormone receptor-positive breast cancer. The study is actively recruiting or closed to recruitment with an actual enrollment of 24 participants. No efficacy or safety results are reported in this registry record.
Phase 1, Interventional, Randomized, Sequential, Open label, Treatment purpose. Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Ca…; age from 18 Years. Intervention: Phase I Part A Dose 1 (copanlisib, abemaciclib, fulvestrant); Phase I Part A Dose 2 (copanlisib, abemaciclib, fulvestrant); Phase I Part B Dose 1b (copanlisib, abemaciclib, fulvestran…. Compared with: Phase I Part B Dose 2b (copanlisib, abemaciclib, fulvestran… — Active Comparator. n = 24. 14 sites: United States.
This is a Phase 1 trial registration (NCT03939897) testing copanlisib added to fulvestrant and abemaciclib in metastatic HER2-negative, hormone receptor-positive breast cancer. The study is actively recruiting or closed to recruitment with an actual enrollment of 24 participants. No efficacy or safety results are reported in this registry record.
This registry record reports no study results; outcomes for safety, tolerability, or efficacy are not yet posted. Phase 1 design focuses on dose-limiting toxicity; efficacy data not available.
The source did not state who this applies to in practice.
Phase 1 trial of a three-drug combination in metastatic breast cancer with dose-limiting toxicity as the primary endpoint; no results posted in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03939897). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 24 participants (ACTUAL). Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma, Recurrent Breast Carcinoma. Interventions: DRUG: Abemaciclib; PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; DRUG: Copanlisib Hydrochloride; PROCEDURE: Diagnostic Imaging Testing; PROCEDURE: Echocardiography Test; DRUG: Fulvestrant; PROCEDURE: Multigated Acquisition Scan. Primary outcome measures: Dose-limiting Toxicity (DLT) , Up to 28 days from drug administration. Brief summary: This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread from where it first started (breast) to other places in the body (metastatic). Some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer.
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