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Laboratory Biomarker Analysis / Metastatic Breast Carcinoma / Veliparib · Phase 1 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 dose-escalation trial of cyclophosphamide plus veliparib in locally advanced or metastatic breast cancer, currently active but not recruiting. No results have been posted to the registry; the study aims to determine the recommended Phase 2 dose and assess safety and tolerability over a 21-day cycle.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Ca…; age from 18 Years. Intervention: Treatment (veliparib, cyclophosphamide). n = 35. 5 sites: United States.
This is a Phase 1 dose-escalation trial of cyclophosphamide plus veliparib in locally advanced or metastatic breast cancer, currently active but not recruiting. No results have been posted to the registry; the study aims to determine the recommended Phase 2 dose and assess safety and tolerability over a 21-day cycle.
This is a registry record only; no results are posted and no efficacy, safety, or dosing data are available.
The source did not state who this applies to in practice.
This is a Phase 1 dose-escalation study with no results yet posted; it addresses safety and recommended dose, not efficacy or clinical benefit.
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 (NCT01351909). 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: 35 participants (ACTUAL). Conditions: Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7. Interventions: DRUG: Cyclophosphamide; OTHER: Laboratory Biomarker Analysis; DRUG: Veliparib. Primary outcome measures: Recommended phase II dose of veliparib and cyclophosphamide , 21 days. Brief summary: This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib when given together in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with veliparib may work better in treating breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.