Phase 2
Completed N=169
Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer
Breast Cancer · Breast Tumors · Malignant Neoplasm of Breast
Source: ClinicalTrials.gov NCT02187991 ↗
Enrolled (actual)
169
Serious AEs
12.4%
Results posted
Oct 2024
Primary outcomePrimary: Time to Disease Progression - Tumor Response Based on RECIST 1.1 Criteria — 7.1; 10.2; 5.7; 9.6 months
Summary
The goal of this clinical research study is to learn if the study drug, alisertib (MLN8237), in combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative or HR-negative, HER2-negative (triple negative) locally recurrent or metastatic breast cancer (MBC). The safety of alisertib in combination with paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if alisertib plus paclitaxel is safe and effective in patients with this type of breast cancer.
Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer, including breast cancer, and preclinical studies suggest that blocking the activity of this protein can lead to the death of cancer cells.
Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer, including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in cancer therapy, combinations of drugs are often more effective as a treatment than either of the same drugs used alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Progression - Tumor Response Based on RECIST 1.1 Criteria |
7.1; 10.2; 5.7; 9.6 | — |
| SECONDARY Overall Survival |
25.1; 26.3; 12.7; 16.0 | — |
Eligibility Criteria
Inclusion Criteria
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care, and signed Health Insurance Portability and Accountability Act (HIPAA) form.
- Female subject (≥18 years old), who is either:
- post-menopausal for at least one year before the screening visit, or
- surgically sterilized, or
- willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide) for the duration of the study.
- Metastatic or locally recurrent breast cancer with histologic confirmation (on either primary or metastatic tumor) of one of the following:
- ER+, HER2- invasive breast cancer (any progesterone receptor [PgR] status)
- Poorly differentiated and/or Grade 3 invasive TNBC, defined as:
- HER2 negative status (based on most recently analyzed biopsy) is defined as immunohistochemistry (IHC) status of 0, 1+ or 2+ (if IHC 2+, a negative FISH test is required, i.e., HER2 fluorescence in situ hybridization (FISH) ratio 1500/mm³, platelets > 100,000/mm³, Hgb > 9 g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days, however, erythrocyte growth factor is allowed as per published American Society of Clinical Oncology (ASCO) guidelines (available at: http://www.asco.org/quality-guidelines/asco-ash-clinical-practice-guideline-update-use-epoetin-and-darbepoetin-adult).
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN), serum glutamic-oxaloacetic transaminase (SGOT) (AST) and serum glutamic-pyruvic transaminase (SGPT) (ALT) grade 1
- Known severe hypersensitivity to paclitaxel
Data sourced from ClinicalTrials.gov (NCT02187991). 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. Informational only — not medical advice.