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

NCT07405801 · ClinicalTrials.gov registry record · Phase 2

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer

A Phase 2 study, sponsored by Hoffmann-La Roche.

Recruiting
Registry status
Phase 2
Development phase
80
Enrollment target

NCT07405801: Recruiting Phase 2 study, sponsored by Hoffmann-La Roche.

NCT07405801 is a Phase 2 study that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT07405801, a Phase 2 study, is actively recruiting participants, sponsored by Hoffmann-La Roche.

RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).

Interventions

  • DRUG Placebo
  • DRUG Fulvestrant
  • DRUG Ribociclib
  • DRUG Inavolisib

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2026-04-07
Est. Completion 2030-02-26
Phase Phase 2
Hoffmann-La Roche

909 total trials

What NCT07405801 shows while recruiting

NCT07405801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT07405801 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07405801 about?

NCT07405801 is a clinical study titled "A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer". A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth fact...

What is the current status of trial NCT07405801?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2026-04-07. Estimated completion is 2030-02-26.

What interventions are being tested in trial NCT07405801?

The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Ribociclib (DRUG), Inavolisib (DRUG).

Who is sponsoring clinical trial NCT07405801?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07405801's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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

  • NCT01243931 · 80 participants · NA

    Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

  • NCT01659203 · 80 participants · Phase 1

    Proton or Photon RT for Retroperitoneal Sarcomas

  • NCT01803451 · 80 participants · Early Phase 1

    Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

  • NCT01964859 · 80 participants · Phase 2

    Feasibility Study for Fibroblast Autologous Skin Grafts

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

Source: ClinicalTrials.gov NCT07405801, the US trial registry maintained by the National Library of Medicine. NCT07405801 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.