Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03207529|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Androgen Receptor Positive Estrogen Receptor Negative Estrogen Receptor Positive HER2/Neu Negative Metastatic Breast Carcinoma Progesterone Receptor Negative Progesterone Receptor Positive Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 PTEN Positive Recurrent Breast Carcinoma Refractory Breast Carcinoma Triple-Negative Breast Carcinoma||Drug: Alpelisib Drug: Enzalutamide||Phase 1|
I. To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of the combination of alpelisib (BYL719) and enzalutamide in patients with androgen receptor (AR)-positive and PTEN-positive metastatic breast cancer.
I. To determine the dose-limiting toxicity (DLT) of the combination of BYL179 and enzalutamide.
II. To determine the safety profile of BYL179 and enzalutamide used in combination.
III. Progression-free survival (PFS) and clinical benefit rate (CBR) (complete response or partial response + prolonged stable disease) after a 16-week treatment of BYL719 and enzalutamide per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
I. To determine the association between aberrant circulating tumor cells (CTCs), circulating tumor deoxyribonucleic acid (ctDNA), and CBR at 16 weeks.
II. To determine the association between PIK3CA and PTEN mutations and treatment response to the combination of BYL179 and enzalutamide.
III. To determine the association between PIK3CA mutation status change in ctDNA and treatment response.
IV. To determine the molecular (CTC, ctDNA) profile of tumors that become resistant to treatment in comparison with those prior to treatment.
V. To determine the association between the AR expression level measured by immunohistochemistry (IHC) staining of tumor and CBR at 16 weeks.
OUTLINE: This is a dose-escalation study of alpelisib.
Patients receive alpelisib orally (PO) and enzalutamide PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer|
|Actual Study Start Date :||June 7, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Treatment (alpelisib, enzalutamide)
Patients receive alpelisib PO and enzalutamide PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Maximum tolerated dose (MTD) of alpelisib in combination with enzalutamide [ Time Frame: Up to 28 days ]
- Incidence of adverse events [ Time Frame: Up to 16 weeks ]Standard descriptive analysis will be used to summarize the data.
- Profession-free survival (PFS) [ Time Frame: up to 16 weeks ]Will be estimated using Kaplan-Meier survival curves.
- Clinical benefit rate (CBR) (complete response or partial response + prolonged stable disease) [ Time Frame: Up to 16 weeks ]Will be evaluated according to RECIST version 1.1. Standard descriptive analysis will be used to summarize the data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207529
|Contact: Meghan S. Karuturi, MDfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Meghan Karuturi 713-792-2817|
|Principal Investigator: Meghan Karuturi|
|Principal Investigator:||Meghan Karuturi||M.D. Anderson Cancer Center|