Clinical trial · Interventional
A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
NCT05654623CI-TRIAL-00105843VERITAC-2active not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARV-471 | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARV-471
- interventionNames
- Drug: ARV-471
- type
- ACTIVE_COMPARATOR
- label
- Fulvestrant
- interventionNames
- Drug: Fulvestrant
Primary outcomes (2)
- measure
- Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants
- timeFrame
- From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
- description
- PFS assessed by BICR was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) per RECIST v1.1, or death due to any cause, whichever occurred first. PD as per RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to the timepoint under evaluation), with a minimum absolute increase of 5 millimeters (mm) relative to nadir or unequivocal progression of existing non-target lesions or the presence of new lesions. PFS was censored on the date of last adequate disease assessment for those who did not have a PFS event, discontinued the study treatment due to withdrawal of consent prior to an event, started a new anticancer therapy prior to an event, had an event after a gap of 2 or more missing disease assessments, or lost to follow-up. Kaplan-Meier method was used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy * Confirmed diagnosis of ER+/HER2- breast cancer * Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria: * One line of CDK4/6 inhibitor therapy in combination with endocrine therapy. Only one line of CDK4/6 inhibitor is allowed in any setting. * ≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET * Most recent endocrine treatment duration must have been given for ≥6 months prior to disease progression. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy. * Radiological progression during or after the last line of therapy. * Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Participants should be willing to provide blood and tumor tissue Exclusion Criteria: * Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term * Prior treatment with: * ARV-471, fulvestrant, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting * other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting * prior chemotherapy for advanced/metastatic disease * Inadequate liver, kidney and bone marrow function * Active brain metastases * Participants with significant concomitant illness
References
Publications (2)
- DERIVEDCampone M, De Laurentiis M, Jhaveri K, Hu X, Ladoire S, Patsouris A, Zamagni C, Cui J, Cazzaniga M, Cil T, Jerzak KJ, Fuentes C, Yoshinami T, Rodriguez-Lescure A, Sezer A, Fontana A, Guarneri V, Molckovsky A, Mouret-Reynier MA, Demirci U, Zhang Y, Valota O, Lu DR, Martignoni M, Parameswaran J, Zhi X, Hamilton EP; VERITAC-2 Study Group. Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer. N Engl J Med. 2025 Aug 7;393(6):556-568. doi: 10.1056/NEJMoa2505725. Epub 2025 May 31. PMID 40454645
- DERIVEDHamilton EP, Ma C, De Laurentiis M, Iwata H, Hurvitz SA, Wander SA, Danso M, Lu DR, Perkins Smith J, Liu Y, Tran L, Anderson S, Campone M. VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER degrader, versus fulvestrant in ER+/HER2- advanced breast cancer. Future Oncol. 2024;20(32):2447-2455. doi: 10.1080/14796694.2024.2377530. Epub 2024 Jul 29. PMID 39072356