--- title: "Advanced Breast Cancer HR+ HER2- WO45654 | Sutter Health" description: "A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer" url: "https://www.sutterhealth.org/research/clinical-trials/advanced-breast-cancer-hr-her2-wo45654-2044043570" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Clinical trials](https://www.sutterhealth.org/research/clinical-trials) / 4. Advanced Breast Cancer HR+ HER2- WO45654 # Advanced Breast Cancer HR+ HER2- WO45654 **Status:** Open to Enrollment [Email us to enroll](https://www.sutterhealth.org/research/clinical-trials/advanced-breast-cancer-hr-her2-wo45654-2044043570#enroll) #### Study details View study details on [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06790693). #### Locations - San Mateo - Sunnyvale - Mountain View #### Clinical trial FAQs Information for patients and study volunteers, including [frequently asked questions](https://www.sutterhealth.org/research/faqs). A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer ![Tanya Gupta, M.D.](https://dyn.mktgcdn.com/p/CPzK5LScISvhHOk2tx5EPqk547IeQTsDz-wwsjId1Bo/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Tanya Gupta, M.D. Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/tanya-gupta-md-2087176158) ## Sub-Investigators [Natalia Colocci, M.D., Ph.D.](https://www.sutterhealth.org/research/investigators/natalia-colocci-md-phd-1049680997) , [Judy M Cheng, M.D., PhD](https://www.sutterhealth.org/research/investigators/judy-m-cheng-md-phd-2087172375) ## Email us to enroll - [Email San Mateo](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Advanced%20Breast%20Cancer%20HR%2B%20HER2-%20WO45654%20in%20San%20Mateo&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) - [Email Sunnyvale](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Advanced%20Breast%20Cancer%20HR%2B%20HER2-%20WO45654%20in%20Sunnyvale&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) - [Email Mountain View](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Advanced%20Breast%20Cancer%20HR%2B%20HER2-%20WO45654%20in%20Mountain%20View&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) ## Related clinical trials [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) - Clinical trial ### [Adjuvant Breast Cancer A012103 OptimiCE-PCR](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-a012103-optimice-pcr-1094794503) OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy **Status:** Open to Enrollment - Clinical trial ### [Adjuvant Breast Cancer ER-pos/HER2-neg EA1242](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-cancer-er-pos-her2-neg-ea1242-2072227055) A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS≤25 (RxFINE-Low) **Status:** Open to Enrollment - Clinical trial ### [Adjuvant Breast NRG-BR009](https://www.sutterhealth.org/research/clinical-trials/adjuvant-breast-nrg-br009-1049142000) A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) **Status:** Open to Enrollment - Clinical trial ### [Adjuvant Triple NegativeBreast Cancer Ascent-05](https://www.sutterhealth.org/research/clinical-trials/adjuvant-triple-negative-breast-cancer-ascent-05-2022817141) A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy **Status:** Open to Enrollment - Clinical trial ### [Advanced or Metastatic Breast Cancer C4551002](https://www.sutterhealth.org/research/clinical-trials/advanced-or-metastatic-breast-cancer-c4551002-2060622373) An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy **Status:** Open to Enrollment [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter 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