Please ensure that you have obtained local R&D approval for this amendment before using these documents. All documents require a username and password login to access; please contact the Trial Office if you require these.
- SA23 MHRA Approval Documents v1.0 [PDF, 659 KB]
- SA23 MHRA Cover Letter [404KB]
- MHRA CTA Application [1.67MB]
- SA23 HRA Approval Documents v1.0 [PDF, 256 KB]
- SA23 REC Cover letter [458KB]
- SA23 REC Approval Documents v1.0 [PDF, 734 KB]
- SA23 Locked Amendment Tool [428KB]
- Trial Protocol v11.0 08-Sep-2021 CLEAN [PDF, 5.02 MB]
- Trial Protocol v11.0 08-Sep-2021 TRACKED [PDF, 5.02 MB]
- Trial Protocol Synopsis 11.0 01-Apr-2021 CLEAN [PDF, 325 KB]
- Trial Protocol Synopsis 11.0 01-Apr-2021 TRACKED [PDF, 325 KB]
- Summary of Protocol Changes [147KB]
- Protocol Signature page v11.0 [184KB]
- Arm C: Palbociclib – PIS & ICF v11.0 20-Jul-21 CLEAN [Word, 244 KB]
- Arm C: Palbociclib – PIS & ICF v11.0 20-Jul-21 tracked [Word, 247KB]
- Arm J: AZD6738 & Durvalumab – PIS & ICF v3.0 22-Jun-21 [Word, 356 KB]
- Arm J: AZD6738 & Durvalumab – PIS & ICF v3.0 22-Jun-21 tracked [Word, 359 KB]
- Archive Tissue PIS&ICF_v1.0-12-Mar-2021 [Word, 880KB]
Please note: Investigators Brochures (IBs) will be sent to sites via email.
Please note: Patient Documents should be localised using hospital headed paper.