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NCT07405801
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
Phase 2 trial testing Inavolisib in Breast Cancer in 80 participants. Currently enrolling.
19 December 2028
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 30 April 2026 |
| Primary completion | 19 December 2028 |
| Estimated completion | 26 February 2030 |
| Sites | 10 locations across Canada, Brazil, South Korea |
Drugs / interventions tested
- Inavolisib (INAVOLISIB) — full drug profile →
- Ribociclib (ribociclib) — full drug profile →
- Fulvestrant (fulvestrant) — full drug profile →
- Placebo
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07405801
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07405801 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07405801.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing