Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04862663 · ClinicalTrials.gov registry record · Phase 3

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

A Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 3
Development phase
895
Enrollment target
20
Study locations

NCT04862663: Recruiting Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer, sponsored by AstraZeneca.

NCT04862663 is a Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 895 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04862663, a Phase 3 study of Locally Advanced (Inoperable) or Metastatic Breast Cancer, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 3
Development phase
895 participants
Enrollment target
20
Study locations

Study Summary

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Primary Outcome

Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria.

Conditions Studied

Locally Advanced (Inoperable) or Metastatic Breast Cancer

Interventions

  • DRUG Fulvestrant
  • DRUG Palbociclib
  • DRUG Abemaciclib
  • DRUG Ribociclib
  • DRUG Capivasertib

Study Locations (20)

California

  • Research Site - Fountain Valley
  • Research Site - Glendale
  • Research Site - Los Angeles
  • Research Site - Los Angeles
  • Research Site - Napa
  • Research Site - Newport Beach
  • Research Site - San Francisco
  • Research Site - Santa Barbara
  • Research Site - Santa Rosa

Kentucky

  • Research Site - Louisville
  • Research Site - Louisville

Louisiana

  • Research Site - Baton Rouge
  • Research Site - Covington

Arizona

  • Research Site - Tucson

Colorado

  • Research Site - Aurora

Connecticut

  • Research Site - New Haven

Delaware

  • Research Site - Newark

Illinois

  • Research Site - Quincy

Trial Details

FieldValue
Enrollment Target 895 participants
Start Date 2021-05-10
Est. Completion 2029-08-14
Phase Phase 3
AstraZeneca

1,285 total trials

What NCT04862663 shows while recruiting

NCT04862663 is an interventional study that assigns participants to a tested intervention. The registered 895 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher).

The record links to 1 condition, with Locally Advanced (Inoperable) or Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.

NCT04862663 names 20 study sites across 10 states, led by California, Kentucky, Louisiana.

Frequently Asked Questions

What is clinical trial NCT04862663 about?

NCT04862663 is a clinical study titled "Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)". A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

What is the current status of trial NCT04862663?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 895 participants. The study started on 2021-05-10. Estimated completion is 2029-08-14.

What conditions does trial NCT04862663 study?

This clinical trial studies the following conditions: Locally Advanced (Inoperable) or Metastatic Breast Cancer.

What interventions are being tested in trial NCT04862663?

The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), Capivasertib (DRUG).

Who is sponsoring clinical trial NCT04862663?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04862663 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Locally Advanced (Inoperable) or Metastatic 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 NCT04862663's enrollment target sits among peer trials

895 361st of 2000 higher than 1,639 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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

  • NCT05855200 · 892 participants · Phase 3

    Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

  • NCT02352116 · 900 participants · NA

    Evaluation of Post-PACU Pain Management in Pediatric Surgery

  • NCT02414347 · 900 participants

    F 18 T807 Tau PET Imaging of Alzheimer's Disease

  • NCT02670408 · 900 participants

    Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation

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

More recruiting context for NCT04862663

Source: ClinicalTrials.gov NCT04862663, the US trial registry maintained by the National Library of Medicine. NCT04862663 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.