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NCT07195227: CADILLAC
Phase II Study to Evaluate the Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Hormone Receptor Positive (HR+) Breast Cancer
Phase 2 trial testing Camizestrant in Hormon Receptor Positive Breast Cancer in 150 participants. Currently enrolling.
1 February 2028
Quick facts
| Lead sponsor | MedSIR |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 24 March 2026 |
| Primary completion | 1 February 2028 |
| Estimated completion | 1 March 2028 |
| Sites | 16 locations across Germany, Spain |
Drugs / interventions tested
- Camizestrant — full drug profile →
- Ribociclib (ribociclib) — full drug profile →
Conditions studied
- Hormon Receptor Positive Breast Cancer — all drugs for Hormon Receptor Positive Breast Cancer →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
MedSIR — full company profile →
Who can join
18 and older, any sex, with Hormon Receptor Positive Breast Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Progression Free Survival (PFS)
Time frame: Up to 28 months
PFS, defined as the time from the date of the first dose until the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1.
Sponsor's own description
This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS). The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy are projected to outweigh the risks of this treatment. This Study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07195227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Camizestrant
Trials testing the same drug.
- NCT07427394 — Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Br · Phase 2 · not yet recruiting
- NCT06547164 — A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investiga · Phase 1 · completed
- NCT06380751 — Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-P · Phase 3 · recruiting
- NCT06188520 — A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Com · Phase 1, PHASE2 · recruiting
- NCT05952557 — An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) · Phase 3 · recruiting
Other MedSIR trials
Trials by the same sponsor.
- NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07178938 — Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases · Phase 2 · not yet recruiting
- NCT05708235 — A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population · Phase 2 · recruiting
- NCT05659563 — Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% · Phase 2 · completed
- NCT05520723 — Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED · Phase 2 · completed
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 NCT07195227 (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 MedSIR
- Last refreshed: 27 May 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/NCT07195227.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing