NCT06125522CompletedPhase 1/2
TACTIVE-U: An Umbrella Study to Investigate the Safety and Antitumor Activity of vepdegestrant (ARV-471) in Combination With Other Medicines in Adults With ER+ Advanced or Metastatic Breast Cancer, Sub-study C (ARV-471 and Samuraciclib)
C4891024 - TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Nov 2025
Brief summary (registry, in English)
Phase 1b: To assess safety and tolerability of ARV-471 in combination with samuraciclib in participants with ER+/HER2- A/MBC to select up to 2 RDEs for the combination. Phase 2: To assess the clinical antitumor activity of ARV-471 in combination with samuraciclib. DDI Assessment Cohort(s): To evaluate the effect of samuraciclib on PK of ARV-471, To evaluate the effect of ARV-471 on PK of samuraciclib.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 31 Oct 2023
- Start date
- 25 Mar 2024
- Lead sponsor
- Pfizer Inc.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06125522
- EU CT number
- 2023-507125-41-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 48
- 13 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with active bleeding, history of hemolytic anemia or marrow aplasia.
- Refractory nausea and vomiting and other gastrointestinal (GI) conditions precluding adequate absorption of study interventions
- History of any other malignancies within the past three years, except for (1) adequately treated basal or squamous cell carcinoma of the skin and (2) curatively treated in situ carcinoma of the cervix.
Other
- Participants in visceral crisis at risk of life-threatening complications in the short term
- Participants with newly diagnosed brain metastases
Who the study is looking for
- Participants must be patients with ER+/HER2- A/MBC, who have been previously treated with up to 2 lines of prior therapies for advanced/metastatic disease including 1 line of any prior CDK4/6 inhibitor-based regimen. The current A/MBC disease must have at least 1 measurable lesion as per RECIST v1.1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Universidad de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | St Herblain | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.