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NCT06613516: CaptAin
Effect of Capivasertib on ctDNA in ER Positive Breast Cancer
Phase 2 trial testing Capivasertib in Breast Cancer. Withdrawn.
16 September 2025
Quick facts
| Lead sponsor | Imperial College London |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 February 2025 |
| Primary completion | 16 September 2025 |
| Estimated completion | 16 September 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Capivasertib — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Oestrogen Receptor Positive Breast Cancer — all drugs for Oestrogen Receptor Positive Breast Cancer →
Sponsor
Imperial College London
Who can join
18 and older, female only, with Breast Cancer or Oestrogen Receptor Positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There is growing evidence that cancer DNA (called circulating tumour DNA - ctDNA) in the blood is often an early sign that the cancer is likely to return. The aim of this study is to investigate whether treating women who have detectable ctDNA in their blood with a drug called Capivasertib can help control ctDNA levels and prevent developing metastatic or secondary breast cancer. A recruitment of 20 women with oestrogen receptor (ER) positive breast cancer (who are already on standard of care hormone therapy who are being treated with curative intent) is aimed for; which means that the disease has not yet spread to distant parts of the body. Each subject will be dosed with 400mg of Capivasertib twice a day for a maximum period of two years.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Precision-Guided Use of PI3K Pathway Inhibitors for the Treatment of Solid Malignancies.
Schmitz AE, Udgata S, Johnson KA, Deming DA. · · 2025 · cited 5× · PMID 40564038 · DOI 10.3390/biomedicines13061319 -
Liquid biopsy in breast cancer: Redefining precision medicine.
Schiavone ML, Scarpitta R, Ravera F, Bleve S, et al · · 2025 · cited 3× · PMID 40740670 · DOI 10.1016/j.jlb.2025.100312 -
Circulating Tumor DNA in Early and Metastatic Breast Cance-Current Role and What Is Coming Next.
Tegeler CM, Hartkopf AD, Banys-Paluchowski M, Krawczyk N, et al · · 2024 · cited 2× · PMID 39682108 · DOI 10.3390/cancers16233919
Verify or expand the search:
- PubMed search for NCT06613516
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Capivasertib
Trials testing the same drug.
- NCT07175415 — HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological · Phase 1, PHASE2 · not yet recruiting
- NCT07241065 — A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in · Phase 1 · recruiting
- NCT07287917 — Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07343960 — A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Imp · Phase 1 · recruiting
- NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI · Phase 3 · recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Imperial College London trials
Trials by the same sponsor.
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- NCT07397455 — Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants · Phase 1 · not yet recruiting
- NCT07422532 — A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing · NA · not yet recruiting
- NCT07389031 — Maralixibat for Intrahepatic Cholestasis of Pregnancy · Phase 2 · not yet recruiting
- NCT07358897 — Gender Affirming Hormone Therapy and Immune Function in Trans Individuals - The GIFT Study · not yet recruiting
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 NCT06613516 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Imperial College London
- Last refreshed: 24 December 2025
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/NCT06613516.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing