Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
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
This phase I trial studies the side effects and best dose of alpelisib when given together with enzalutamide in treating patients with androgen receptor and PTEN positive breast cancer that has spread to other places in the body. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgen receptor can cause the growth of breast cancer cells. Hormone therapy using enzalutamide may fight breast cancer by lowering the amount of androgen the body makes. Giving alpelisib and enzalutamide may work better in treating patients with breast cancer.
PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVES: 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT05673200 -
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03218826 -
PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
| Completed |
NCT04535323 -
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT05464810 -
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
|
Early Phase 1 | |
| Active, not recruiting |
NCT04249622 -
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
|
Phase 2 | |
| Withdrawn |
NCT03666819 -
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
|
Phase 2 | |
| Not yet recruiting |
NCT05930483 -
Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT04862585 -
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT05967286 -
Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
|
Phase 2 | |
| Recruiting |
NCT04593277 -
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
|
N/A | |
| Active, not recruiting |
NCT05086731 -
Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
|
N/A | |
| Recruiting |
NCT05368428 -
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
|
N/A | |
| Recruiting |
NCT04673448 -
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT05539365 -
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04086875 -
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
|
N/A | |
| Completed |
NCT00507923 -
Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
|
N/A | |
| Recruiting |
NCT06058377 -
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Recruiting |
NCT05455658 -
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05674578 -
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
|
N/A |