Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05909397 · ClinicalTrials.gov registry record · Phase 3
Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT05909397: Active Phase 3 study of Breast Cancer, sponsored by Pfizer.
NCT05909397 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 59 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05909397, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to understand the safety and effects of the study medicine vepdegestrant (ARV-471/PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of vepdegestrant plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. Vepdegestrant is a new medicine under study. This study is seeking participants who have breast cancer that: * Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. * Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. * Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with vepdegestrant will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with vepdegestrant. In the Phase 3, half of the participants will take vepdegestrant plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.
Primary Outcome
It is defined as the number of participants with Grade 4 neutropenia AE (graded by NCI CTCAE v.5.0) with onset within the first 4 cycles divided by the number of participants.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Vepdegestrant (ARV-471/PF-07850327)
- COMBINATION_PRODUCT Palbociclib
Study Locations (20)
Rio Grande do Sul
- Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa - Porto Alegre
- Centro de Pesquisa Clínica - Área Administrativa - Porto Alegre
- Hospital Mae de Deus - Porto Alegre
Florida
- BRCR Global - Plantation
- BRCR Medical Center Inc - Plantation
Virginia
- Virginia Oncology Associates - Norfolk
South Australia
- Cancer Research SA - Adelaide
Victoria
- Barwon Health - Geelong
Espírito Santo
- Hospital Santa Rita de Cassia - Vitória
Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Science - Beijing
Guangdong
- Sun Yat-sen University Cancer Center - Guangzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2023-08-09 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 3 |
What the registry record for NCT05909397 still lists
NCT05909397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Letrozole is the first listed.
NCT05909397 names 20 study sites across 17 states, led by Rio Grande do Sul, Florida, Virginia.
Frequently Asked Questions
What is clinical trial NCT05909397 about?
NCT05909397 is a clinical study titled "Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer". The purpose of this study is to understand the safety and effects of the study medicine vepdegestrant (ARV-471/PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of vepdegestrant plus palbociclib to standard of care therapy (...
What is the current status of trial NCT05909397?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2023-08-09. Estimated completion is 2026-12-30.
What conditions does trial NCT05909397 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05909397?
The interventions under investigation include: Letrozole (DRUG), Vepdegestrant (ARV-471/PF-07850327) (DRUG), Palbociclib (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05909397?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05909397 being conducted?
This trial has 20 study locations across Florida, Virginia, South Australia, Victoria, Espírito Santo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05909397's enrollment target sits among peer trials
59 758th of 1224 higher than 465 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
RECRUITING · Phase 3
-
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
RECRUITING · Phase 3
-
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
RECRUITING · Phase 3
-
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
RECRUITING · Phase 3
-
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03801083 · 59 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
- NCT04332367 · 59 participants · Phase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
- NCT05489575 · 59 participants · NA
CPAP for the Treatment of Supine Hypertension
- NCT06721689 · 59 participants · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI