Phase 2
N=33
Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer
Breast Adenocarcinoma · Deleterious BRCA1 Gene Mutation · Deleterious BRCA2 Gene Mutation · HER2/Neu Negative · Invasive Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02282345 ↗Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Feb 2022
Primary outcome: Primary: Number of Participants With Overall Pathological Complete Response (pCR) — 7; 10; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Talazoparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Pathological Complete Response (pCR) |
7; 10; 3; 2; 3; 5 | — |
| PRIMARY Number of Participants With Grade 4 Toxicities |
0; 1 | — |
| SECONDARY Median Clinical Response to Single Agent Talazoparib |
88 | — |
Summary
This phase II trial studies the side effects of talazoparib when given before standard therapy in treating patients with breast cancer that has spread to nearby healthy tissue and has a mutation in a breast cancer, early onset (BRCA) gene. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may be especially effective in patients with BRCA mutations. It is not yet known whether adding talazoparib before standard treatment is safe in treating patients with BRCA mutated breast cancer.
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent
- Histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1 cm on imaging by either mammography, ultrasound or breast magnetic resonance imaging (MRI)
- Negative human epidermal growth factor receptor 2 (HER-2)/neu- disease defined as patients with fluorescence in situ hybridization (FISH) ratio = 3 years prior to current diagnosis and there is no clinical evidence of metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Baseline multi gated acquisition scan (MUGA) or echocardiogram scans with left ventricular ejection fraction (LVEF) of > 50%
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelets >= 100,000/uL
- Hemoglobin (Hgb) >= 9 g/dL
- Creatinine clearance > 50 ml/min
- Total bilirubin = class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy
- Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols
- Unable to take oral medications
- Known to be human immunodeficiency virus positive
- Known active hepatitis C virus, or known active hepatitis B virus
- Concurrent disease or condition that would interfere with study participation or safety, such as any of the following:
- Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug
- Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders
- Non-healing wound, ulcer, or bone fracture
- Known hypersensitivity to any of the components of talazoparib
Data sourced from ClinicalTrials.gov (NCT02282345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.