Trials / Completed
CompletedNCT02379247
BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer
Phase I/II Study of BYL719 and Nab-Paclitaxel in Subjects With Locally Recurrent or Metastatic HER-2 Negative Breast Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Priyanka Sharma · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Investigate the use of BYL719 (alpelisib) as combination therapy with Nab-Paclitaxel in locally recurrent or metastatic HER-2 negative breast cancer.
Detailed description
Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Despite recent improvement in the treatment of breast cancer, 40,000 women still die each year in the US as a result of breast cancer. Chemotherapy (usually consisting of sequential single agent) remains the backbone of treatment for patients with HER-2 negative metastatic breast cancer. A majority of patients show an initial response to treatment, but all eventually show disease progression. The purpose of this study is to determine the highest dose of BYL719 (alpelisib) combined with Nab-Paclitaxel that results in no serious side effects. The safety and effectiveness of BYL719 combined with Nab-Paclitaxel to treat patients with HER-2 negative metastatic breast cancer will be assessed, along with the determination of how long this drug combination will keep the disease from getting worse. The study will be done in two parts: Part 1 will determine the highest dose of BYL719 that is safe and tolerable to take in combination with Nab-Paclitaxel. Part 1 will be completed before Part 2 begins. Part 2 will investigate whether taking BYL719 (at the dose determined in Part 1) + Nab-Paclitaxel is safe and effective for patients with HER-2 negative metastatic breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BYL-719 (alpelisib) | Oral PI3K inhibitor |
| DRUG | Nab-paclitaxel | IV taxane |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2017-09-21
- Completion
- 2022-03-01
- First posted
- 2015-03-04
- Last updated
- 2022-06-07
- Results posted
- 2021-09-28
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02379247. Inclusion in this directory is not an endorsement.